Image Credit: Adobe Stock Images/toa555 Topline Findings Rapid LDL-C Goal Achievement: Leqvio (inclisiran) enabled 84.9% of high-risk hypercholesterolemia patients to reach guideline-recommended LDL-C targets within 90 days. Reduced Muscle-Related Adverse Effects: Patients…
Category: Medicine
2025 Veeva R&D and Quality Summit Clinical Opening Keynote
Jim Reilly, president, Development Cloud, and EVP, global strategy, Veeva Image Credit: Andy Studna In the opening keynote of the clinical operations zone, Jim Reilly, president, Development Cloud, and EVP, global strategy,…
Why Many Health Tech Startups Miss the Mark in Clinical Trials
In a recent video interview with Applied Clinical Trials, Sunny Kumar, MD, partner, Informed Ventures, discussed the slow adoption of DCT models despite their benefits in retention and diversity. Key barriers include…
Roche, Alnylam Launch Phase III Trial for Novel RNAi Therapeutic in Uncontrolled Hypertension
Image Credit: Adobe Stock Images/wutzkoh Roche and Alnylam are launching the Phase III ZENITH cardiovascular outcomes trial (CVOT) to evaluate zilebesiran in patients with uncontrolled hypertension. The RNAi therapeutic was designed to…
What Resilient Trial Design Means for Clinical Teams
In a recent video interview with Applied Clinical Trials, Sunny Kumar, MD, partner, Informed Ventures, discussed the slow adoption of DCT models despite their benefits in retention and diversity. Key barriers include…
FDA Lifts Clinical Hold on Rocket Pharmaceuticals’ Phase II Novel Investigative Gene Therapy Trial for Danon Disease
Image Credit: Adobe Stock Images/nature_photo by ice Topline Findings FDA lifts clinical hold on RP-A501 trial: Rocket Pharmaceuticals’ pivotal Phase II study for Danon disease resumes less than three months after the…
Theravance Biopharma Completes Phase III CYPRESS Trial Enrollment for Novel Norepinephrine Reuptake Inhibitor in Multiple System Atrophy
Image Credit: Adobe Stock Images/Fitry Topline Findings Phase III CYPRESS Enrollment Completed: Theravance Biopharma finishes open-label patient enrollment in the pivotal trial evaluating ampreloxetine for neurogenic orthostatic hypotension in multiple system atrophy….
How Research Sites Balance Funding Cuts and Efficiency Pressures
Lipset: Clearly, this is a very polarizing time politically for a lot of folks, but I think objectively, most would say that efficiencies are needed, and that would be a good thing….
Evrysdi Helps Presymptomatic Infants with Spinal Muscular Atrophy Sit, Stand, and Walk in Phase II Trial
Credit: Dzmitry | stock.adobe.com Infants with spinal muscular atrophy (SMA) administered early treatment with Evrysdi (risdiplam) demonstrated motor milestone achievements that would not have been reached without pharmaceutical intervention, according to new data…
An Evidence-Based Framework for Assessing Site Selection Decisions
Credit: photon_photo | stock.adobe.com Background Clinical trial success depends on selecting appropriate clinical sites. Poor site selection can lead to delayed recruitment, compromised data quality, increased costs, and regulatory risks.16 Despite technological…
Phase III NIMBLE Trial Demonstrates Cemdisiran Efficacy in Generalized Myasthenia Gravis
Image Credit: Adobe Stock Images/Robin What clinops professionals need to know The Phase III NIMBLE trial demonstrated that cemdisiran, given once every 12 weeks, achieved significant improvements in MG-ADL scores in patients…
Why Clinical Trial Innovations Take Years to Gain Adoption
In a recent video interview with Applied Clinical Trials, Sunny Kumar, MD, partner, Informed Ventures, discussed the slow adoption of DCT models despite their benefits in retention and diversity. Key barriers include…
Reimagining Clinical Trials for Remote Populations
Credit: kentoh | stock.adobe.com Decentralized clinic trials are more than a mere trend, they are a revolution in the ways we support, reach and retain populations of patients historically known to have…
Navigating CGM and BGM Decisions in GLP-1 Clinical Trials
Credit: Proxima Studio | stock.adobe.com As GLP-1 therapies expand from diabetes into obesity, cardiovascular disease, and rare conditions, clinical trial teams face a broader choice of measurement and depth of data collection…
Addressing the Digital Divide in Decentralized Trials
In a recent video interview with Applied Clinical Trials, Sunny Kumar, MD, partner, Informed Ventures, discussed the slow adoption of DCT models despite their benefits in retention and diversity. Key barriers include…
FDA Authorizes New COVID Vaccines with Restrictions on Eligibility
Image Credit: © JHVEPhoto – stock.adobe.com For individuals who fall outside of the conditions listed under the new CDC recommendations, the cost of updated vaccines may depend on whether their insurance covers…
Phase I/II RAINFOL-01 Trial Results Lead to FDA Breakthrough Designation for Genmab’s Rina-S for Advanced Endometrial Cancer
Image Credit: Adobe Stock Images/MKS The FDA has granted Breakthrough Therapy Designation (BTD) to Genmab’s Rina-S (rinatabart sesutecan) for the treatment of advanced endometrial cancer (EC) in patients whose disease has progressed…
Why Decentralized Trials Face Slow Adoption Despite Strong Data
In a recent video interview with Applied Clinical Trials, Sunny Kumar, MD, partner, Informed Ventures, discussed the slow adoption of DCT models despite their benefits in retention and diversity. Key barriers include…
FDA Expands Transparency With Daily Adverse Event Reporting
Image Credit: © JHVEPhoto – stock.adobe.com What clinops professionals need to know The FDA will now publish FAERS adverse event data daily, a shift aimed at faster and more transparent safety monitoring….
Bias Starts Early in Research. So Can AI.
Image Credit: © Shuo – stock.adobe.com What clinops professionals need to know Early-stage research is vulnerable to bias due to the vast volume of biomedical data and the limits of time and…
Supreme Court Ruling, VK2735 Obesity Trial, and Padcev-Keytruda Survival Gains
This is the Applied Clinical Trials Brief—your fast track to the latest insights in clinical research operations. In under three minutes, we’ll recap top stories, highlight expert interviews, and keep you current…
NCX 470 Meets Phase III Goal in Glaucoma With Strong Intraocular Pressure Reductions
Image Credit: © Pixel-Shot – stock.adobe.com Nicox has shared positive results from the Phase III Denali clinical trial (NCT04630808) evaluating its NCX 470 0.1%, a novel nitric oxide (NO)-donating bimatoprost eye drop,…
Celldex Therapeutics’ Novel Humanized Monoclonal Antibody Falls Short in Phase II Trial Treating Eosinophilic Esophagitis
Image Credit: Adobe Stock Images/Ti Studio Topline Findings Primary Endpoint Not Met: Barzolvolimab did not improve eosinophilic esophagitis (EoE) symptoms, endoscopic scores, or eosinophil infiltration despite robust mast cell depletion. Mast Cell…
Supreme Court Upholds NIH Funding Cuts Affecting DEI in Clinical Research
Image Credit: © WESTOCK – stock.adobe.com What clinops professionals need to know Recent NIH funding cuts tied to DEI policies are creating uncertainty across the research landscape. Site budgets and staffing remain…
Dynavax Technologies’ Investigational Shingles Vaccine Achieves Complete Antibody Response in Phase I/II Shingles Trial
Image Credit: Adobe Stock Images/Suriyawut Topline Findings Z-1018 Shingles Vaccine Shows Comparable Immunity: In part 1 of the Phase I/II trial (NCT06569823), Dynavax’s Z-1018 achieved antibody and CD4⁺ T-cell responses similar to…
DEI & Clinical Trials: Navigating Policy Shifts
This presentation was generated based on two articles written by Rebecca Johnson, PhD: The Impact of DEI Ban On Clinical Research Ecosystem The Mandate Myth: What Actually Moves the Needle on Inclusive…
Building Partnerships to Better Serve Underrepresented Trial Communities
In a recent video interview Applied Clinical Trials, Caroline Potts, general manager of sites and patient services, Medical Research Network (MRN), discussed operational flexibility in clinical trials, emphasizing the need to avoid…
Phase II Trial Launches of Anktiva in Long COVID Patients
Image Credit: © Production Perig – stock.adobe.com ImmunityBio has initiated a new Phase II study, COVID-4.019-Long (NCT07123727), to evaluate the safety and effectiveness of Anktiva (nogapendekin alfa inbakicept-pmln) in patients with long…
How Flexible Site Models Can Cut Recruitment Costs and Timelines
In a recent video interview Applied Clinical Trials, Caroline Potts, general manager of sites and patient services, Medical Research Network (MRN), discussed operational flexibility in clinical trials, emphasizing the need to avoid…
How Digital Twins and AI Are Reshaping Clinical Trials
This is the Applied Clinical Trials Brief—your fast track to the latest insights in clinical research operations. In under three minutes, we’ll recap top stories, highlight expert interviews, and keep you current…
Overcoming Budget Barriers to Patient-Centric Trial Models
In a recent video interview Applied Clinical Trials, Caroline Potts, general manager of sites and patient services, Medical Research Network (MRN), discussed operational flexibility in clinical trials, emphasizing the need to avoid…
How In-Home and Community Strategies Boost Recruitment and Diversity
In a recent video interview Applied Clinical Trials, Caroline Potts, general manager of sites and patient services, Medical Research Network (MRN), discussed operational flexibility in clinical trials, emphasizing the need to avoid…
Phase II Trial Data Lead to FDA Breakthrough Therapy Designation for Ifinatamab Deruxtecan in Extensive-Stage Small Cell Lung Cancer
Image Credit: Adobe Stock Images/Bartek Topline Findings FDA Breakthrough Therapy Designation (BTD): I-DXd (ifinatamab deruxtecan) receives FDA BTD for pretreated extensive-stage small cell lung cancer, underscoring its potential as a novel therapeutic…
The Reality of Operational Flexibility for Trial Sites
In a recent video interview Applied Clinical Trials, Caroline Potts, general manager of sites and patient services, Medical Research Network (MRN), discussed operational flexibility in clinical trials, emphasizing the need to avoid…
How Policy Changes Could Impact Vaccine Trials and Public Participation
In a recent interview with Applied Clinical Trials, Ron Lanton, partner at Lanton Law, discussed the pivotal role clinical operations professionals play in maintaining the integrity of clinical research and ensuring regulatory…
Vedanta’s Microbiome-Based Candidate Fails to Meet Primary Endpoint in Phase II Trial for Mild-to-Moderate Ulcerative Colitis
Image Credit: Adobe Stock Images/Sean Topline Findings VE202 Phase II Results: Vedanta Biosciences’ VE202 did not meet the trial’s primary endpoints treating mild-to-moderate ulcerative colitis (UC), highlighting ongoing challenges for microbiome-based therapies….
Future-Proofing Trial Protocols to Avoid CRLs
In a recent video interview with Applied Clinical Trials, Meri Beckwith, Co-CEO, Lindus Health, discussed the evolving perception of breakthrough designation amid the FDA’s recent Complete Response Letters (CRLs) issued to Replimune…
Embracing Proactive Multi-Indication Development for Metabolic Therapies
Alan Baldridge, MD, Senior Director, Gastroenterology and Hepatology, Drug Development Solutions, ICON What clinops professionals need to know A 2025 survey of cardiometabolic drug developers found strong interest in multi-indication strategies, yet…
Apreo Health Launches Pivotal BREATHE-3 Trial for Severe Emphysema
Image Credit: Adobe Stock Images/Vii Topline Findings First Patient Treated: Apreo Health has enrolled the first patient in the pivotal BREATHE-3 trial testing the BREATHE Airway Scaffold for severe emphysema. Minimally Invasive…
Phase II Trial Demonstrates Vision Gains in Stargardt Disease With MCO-010
Image Credit: © Pixel-Shot – stock.adobe.com What clinops professionals need to know The Phase II STARLIGHT trial evaluated a single intravitreal injection of MCO-010 in patients with Stargardt disease, demonstrating meaningful gains…
The Critical Role of Clinical Ops Teams in Maintaining Clinical Trial Integrity
In a recent interview with Applied Clinical Trials, Ron Lanton, partner at Lanton Law, discussed the pivotal role clinical operations professionals play in maintaining the integrity of clinical research and ensuring regulatory…
Phase II B-SUPREME Trial Launches for ALG-000184 in Chronic Hepatitis B
Image credit: © Destina – stock.adobe.com What clinops professionals need to know The Phase II B-SUPREME trial is evaluating ALG-000184, a first-in-class oral capsid assembly modulator, in approximately 200 treatment-naïve adults with…
What the Future Holds for Clinical Trials as AI and Digital Twins Become More Embedded
In a recent interview with Applied Clinical Trials, Jon Walsh, founder and chief scientific officer of Unlearn, discussed how AI-designed therapies and digital twin technologies are reshaping the clinical trial landscape. While…
Breaking Down Data Silos to Accelerate Clinical Trials
This is the Applied Clinical Trials Brief—your fast track to the latest insights in clinical research operations. In under three minutes, we’ll recap top stories, highlight expert interviews, and keep you current…
Phase III EV-303/KEYNOTE-905 Shows Padcev Plus Keytruda Improves Event-Free and Overall Survival in Muscle-Invasive Bladder Cancer
Image Credit: © Matthieu – stock.adobe.com Summary The Phase III EV-303/KEYNOTE-905 trial showed that Padcev (enfortumab vedotin) plus Keytruda (pembrolizumab), given before and after surgery, significantly improved event-free survival, overall survival, and…
Phase III VAYHIT2 Trial Demonstrates Ianalumab Plus Eltrombopag Extends Disease Control in Primary Immune Thrombocytopenia
Image Credit: © AkuAku – stock.adobe.com Summary The Phase III VAYHIT2 trial evaluated ianalumab plus eltrombopag versus placebo plus eltrombopag in adults with primary ITP previously treated with corticosteroids. The combination significantly…
FDA Review Changes and the Impact on Trial Design
In a recent video interview with Applied Clinical Trials, Meri Beckwith, Co-CEO, Lindus Health, discussed the evolving perception of breakthrough designation amid the FDA’s recent Complete Response Letters (CRLs) issued to Replimune…
The Power of Digital Twins in Predicting Outcomes for Clinical Trials
In a recent interview with Applied Clinical Trials, Jon Walsh, founder and chief scientific officer of Unlearn, discussed how AI-designed therapies and digital twin technologies are reshaping the clinical trial landscape. While…
Breaking Down Data Silos to Enable Real-Time Trial Oversight
In a recent video interview with Applied Clinical Trials, Luke Wilson, senior director, biotech, pharma services, Thermo Fisher Scientific, discussed the role of data visibility in clinical trials, emphasizing the need for…
FDA Supports Continued Development of Eftilagimod Alfa in PD-L1–Negative Head and Neck Cancer
Credit: Lars Neumann | stock.adobe.com Summary The FDA has endorsed further development of Immutep’s eftilagimod alfa (efti) in combination with Keytruda for first-line HNSCC patients with PD-L1 CPS <1, following positive Phase…
How Integrated Systems Help Biotechs Stay Inspection-Ready
In a recent video interview with Applied Clinical Trials, Luke Wilson, senior director, biotech, pharma services, Thermo Fisher Scientific, discussed the role of data visibility in clinical trials, emphasizing the need for…
Strategies to Accelerate Modern Clinical Trials
Cindy Henderson, chief strategy officer, Veristat Summary Protocol complexity is rising across therapeutic areas, driving costly delays and frequent amendments—now affecting 76% of trials. New guidance emphasizes early cross-functional collaboration, site and…
Roche Reports Five-Year Data Supporting Long-Term Durability of Susvimo in Neovascular Age-Related Macular Degeneration
Image Credit: © Pixel-Shot – stock.adobe.com Summary The five-year Phase III Portal data reinforce the long-term durability of Susvimo in neovascular AMD, showing that 95% of patients required no supplemental treatment between…
Why Real-Time Data Visibility Is Essential for Biotech Clinical Trials
In a recent video interview with Applied Clinical Trials, Luke Wilson, senior director, biotech, pharma services, Thermo Fisher Scientific, discussed the role of data visibility in clinical trials, emphasizing the need for…
Placebos, Politics, and the Ethics of Vaccine Trials
This is the Applied Clinical Trials Brief—your fast track to the latest insights in clinical research operations. In under three minutes, we’ll recap top stories, highlight expert interviews, and keep you current…
Cardiff Reports 49% Response Rate With Onvansertib in RAS-Mutated Colorectal Cancer
Image Credit: © Sebastian Kaulitzki – stock.adobe.com Key takeaways The 30 mg onvansertib arm demonstrated a 49% confirmed ORR versus 30% with standard-of-care alone, with early PFS trends and dose-dependent efficacy supporting…
Kisunla Slows Cognitive and Functional Decline Over Three Years in Phase III Alzheimer Long-Term Extension Trial
Image Credit: Adobe Stock Images/Orawan Key Takeaways Sustained Benefit Over Three Years: Kisunla continued to slow cognitive and functional decline in patients with early Alzheimer disease (AD), with benefits growing over time….
Obicetrapib Shows Alzheimer’s Biomarker Reduction in Phase III BROADWAY Trial
Image Credit: Adobe Stock Images/MUdaylah Key takeaways Obicetrapib 10 mg significantly reduced plasma p-tau217 levels over 12 months in both the full analysis set and ApoE4 carriers, suggesting potential to slow Alzheimer’s…
FDA Clears Alphamab’s Anti-HER2 Biparatopic Antibody-Drug Conjugate for Phase II Ovarian Cancer Trial
Image Credit: Adobe Stock Images/Pete Key Takeaways FDA Approval for JSKN003 Trial: Alphamab Oncology received FDA approval to start a Phase II trial for the novel therapy for platinum-resistant ovarian cancer, expanding…
Monthly Ivermectin Cuts Malaria Infection by 26% in Kenyan Phase III BOHEMIA Trial
Image Credit: © Dr_Microbe – stock.adobe.com Key takeaways Monthly ivermectin administration reduced malaria incidence by 26% versus albendazole, meeting WHO efficacy thresholds and demonstrating potential as a community-wide vector-control strategy. The BOHEMIA…
Adapting to a Changing Research Funding Landscape
In a recent video interview with Applied Clinical Trials, Michael Miller, chief operating officer, Quanterix, discussed how the clinical research industry is increasingly integrating biomarkers. Biomarkers are particularly beneficial in neurology, where…
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What Clinical Ops Teams Must Know About Biomarkers in Trials
In a recent video interview with Applied Clinical Trials, Michael Miller, chief operating officer, Quanterix, discussed how the clinical research industry is increasingly integrating biomarkers. Biomarkers are particularly beneficial in neurology, where…
VYNE Ends Phase IIb Vitiligo Trial of Repibresib After Missing Primary Endpoint
Image Credit: © Axel Bueckert – stock.adobe.com Key takeaways Repibresib missed both primary and key secondary endpoints in Phase IIb, but showed nominally significant improvements in percent F-VASI and T-VASI reduction at…
Jaypirca Demonstrates Strong Efficacy Treating Chronic Lymphocytic Leukemia, Small Lymphocytic Lymphoma in Phase III Trial
Image Credit: Adobe Stock Images/peerawat Key Takeaways Jaypirca Shows Superior Overall Response Rate (ORR) to Imbruvica: In the Phase III BRUIN CLL-314 trial, Jaypirca (pirtobrutinib) achieved a statistically significant improvement in ORR…
AbbVie Submits sNDA to FDA for Venclexta-Acalabrutinib Combo in Frontline CLL
Image Credit: © chayantorn – stock.adobe.com Key takeaways The AMPLIFY trial supports a fixed-duration, all-oral regimen of venetoclax and acalabrutinib, showing a 35% reduction in risk of disease progression or death in…
Growing Excitement Around Biomarkers in Clinical Trials
In a recent video interview with Applied Clinical Trials, Michael Miller, chief operating officer, Quanterix, discussed how the clinical research industry is increasingly integrating biomarkers. Biomarkers are particularly beneficial in neurology, where…
Ilumya Achieves Positive Phase III Results in Psoriatic Arthritis Trials
Credit: Andrii | stock.adobe.com Key takeaways Ilumya demonstrated statistically significant ACR20 responses at Week 24 in both biologic-experienced and biologic-naïve patients with psoriatic arthritis. Safety outcomes remained consistent with Ilumya’s established profile,…
How Research Institutions Can Future-Proof Compliance Programs
In a recent video interview with Applied Clinical Trials, Kate Gallin Heffernan, life sciences attorney, Epstein Becker Green, discussed the challenges clinical research teams face with compliance due to evolving executive orders…
The Quiet Risks of Ignoring Executive Orders in Research
In a recent video interview with Applied Clinical Trials, Kate Gallin Heffernan, life sciences attorney, Epstein Becker Green, discussed the challenges clinical research teams face with compliance due to evolving executive orders…
Clinical Trial Searches Delay Treatment for Nearly 75% of Physicians
Image Credit: Adobe Stock Images/jam Key Takeaways Clinical trial searches are delaying treatment: Around 72% of physicians in the United States say finding relevant trials takes too long, slowing patient access to…
Balancing DEI Reporting With Legal Risk
In a recent video interview with Applied Clinical Trials, Kate Gallin Heffernan, life sciences attorney, Epstein Becker Green, discussed the challenges clinical research teams face with compliance due to evolving executive orders…
What July’s CRLs to Replimune and Capricor Mean for Sponsors
Image Credit: © JHVEPhoto – stock.adobe.com Key takeaways Expect heightened scrutiny of trial design: Recent CRLs underscore that even previously aligned study protocols can be challenged if the FDA determines the design…
Alexion’s Dual-Binding Nanobody Demonstrates Statistically Significant Improvements in Generalized Myasthenia Gravis
Image Credit: Adobe Stock Images/Robin Key Takeaways Gefurulimab shows promise in generalized myasthenia gravis (gMG) treatment: Phase III PREVAIL trial results demonstrate statistically significant and clinically meaningful improvements in Myasthenia Gravis Activities…
Performing Risk Assessments Amid Shifting Federal Guidelines
In a recent video interview with Applied Clinical Trials, Kate Gallin Heffernan, life sciences attorney, Epstein Becker Green, discussed the challenges clinical research teams face with compliance due to evolving executive orders…
Obefazimod Achieves Clinical Remission in Phase III Ulcerative Colitis Trials
Image Credit: Adobe Stock Images/Bungon Key Takeaways Obefazimod delivers statistically significant clinical remission in Ulcerative Colitis (UC): The 50 mg oral dose met the primary endpoint at week eight in both ABTECT-1…
Astegolimab Shows Mixed Results in COPD Trials, Meeting Endpoint in ALIENTO but Not in ARNASA
Image Credit: © peterschreiber.media – stock.adobe.com Key takeaways The ALIENTO Phase IIb study met its primary endpoint, demonstrating a 15.4% reduction in annualized exacerbation rate with astegolimab administered every two weeks. The…
FDA’s Elsa AI Tool Raises Accuracy and Oversight Concerns
Image Credit: © JHVEPhoto – stock.adobe.com Key takeaways FDA’s internal AI assistant, Elsa, has experienced accuracy issues, including generating false citations and data hallucinations. While Elsa aims to expedite tasks like protocol…
FDA Issues Complete Response Letter to Replimune for RP1 Combination Therapy in Advanced Melanoma
Image Credit: Adobe Stock Images/Markus Key Takeaways FDA cites trial design concerns in Complete Response Letter (CRL) to Replimune: The agency rejected the RP1 Biologics License Application (BLA) due to issues with…
Understanding Executive Orders and Trial Compliance
In a recent video interview with Applied Clinical Trials, Kate Gallin, Heffernan, life sciences attorney, Epstein Becker Green, discussed the challenges clinical research teams face with compliance due to evolving executive orders…
What Clinical Researchers Need to Know About Global Obesity Drug Development
In an interview with Applied Clinical Trials, Shipra Patel, global therapeutic area section head for endocrinology and global head of pediatrics at Parexel, discussed the evolving landscape of obesity drug development and what…
Social Media Outperforms Traditional Methods for Recruiting Patients with Depression in Clinical Trials
Image Credit: Adobe Stock Images/Jorm Sangsorn Key Takeaways Online recruitment boosts trial efficiency and diversity: Social media platforms such as Instagram and Facebook enabled faster enrollment and improved representation in mental health…
Viatris Updates Phase III Blepharitis Trial of MR-139, Highlights Progress in Presbyopia and Night Vision Programs
Image Credit: © Pixel-Shot – stock.adobe.com Key takeaways The MR-139 blepharitis trial missed its primary endpoint, prompting reevaluation of future study plans. Positive outcomes from MR-141 and MR-142 programs highlight continued momentum…
How Parexel Supports Cross Functional Trials for Emerging GLP-1 Therapies
In an interview with Applied Clinical Trials, Shipra Patel, global therapeutic area section head for endocrinology and global head of pediatrics at Parexel, discussed the evolving landscape of obesity drug development and…
Anselamimab Misses Primary Endpoint in Phase III CARES Trials for AL Amyloidosis
Image Crddit: © yanapopovaiv – stock.adobe.com Key takeaways The Phase III CARES program evaluating anselamimab did not meet its primary endpoint in the overall population but showed promise in a prespecified subgroup….
The Future of Clinical Trials in Community-Based Settings
In a recent video interview with Applied Clinical Trials, Ramita Tandon, chief biopharma officer, Walgreens, discussed the company’s three-year milestone of leading clinical trials. Tandon highlighted several of Walgreens’ initiatives in the…
Managing Side Effects and Dosing in Off-Label GLP-1 Use with Help from Real-World Evidence
In an interview with Applied Clinical Trials, Shipra Patel, global therapeutic area section head for endocrinology and global head of pediatrics at Parexel, discussed the evolving landscape of obesity drug development and…
ODAC Votes Against Risk-Benefit Profile of GSK’s Blenrep Combinations in Relapsed/Refractory Multiple Myeloma
Image Credit: Adobe Stock Images/Khella Key Takeaways ODAC vote raises safety concerns over Blenrep combinations: FDA advisory panel cited significant ocular adverse events and voted against Blenrep-based regimens for relapsed/refractory multiple myeloma….
Phase IIIb VOLITION Trial Shows Strong Patient Preference for Long-Acting HIV Therapy After Rapid Suppression on Oral Treatment
Image Credit: © Ezume Images – stock.adobe.com Key takeaways 89% of eligible participants in the VOLITION trial chose to switch from daily oral treatment to long-acting injectables after viral suppression. Real-world data…
Gilead’s Yeztugo Demonstrates Strong HIV Prevention Results in Underserved Populations
Image Credit: Adobe Stock Images/Nurillo Key Takeaways Twice-yearly pre-exposure prophylaxis (PrEP) shows strong efficacy: Yeztugo prevented HIV infections in pregnant women and young people across both PURPOSE 1 and PURPOSE 2 Phase…
Advice for CROs and Sponsors Partnering With Retail Trial Sites
In a recent video interview with Applied Clinical Trials, Ramita Tandon, chief biopharma officer, Walgreens, discussed the company’s three-year milestone of leading clinical trials. Tandon highlighted several of Walgreens’ initiatives in the…
SurVaxM Shows Continued Promise in Glioblastoma as Phase IIb SURVIVE Trial Progresses
Image Credit: © stockdevil – stock.adobe.com Key takeaways Interim analysis from the randomized Phase IIb SURVIVE trial supports continued evaluation of SurVaxM in newly diagnosed glioblastoma. The SURVIVE study builds on earlier…
Inside the GLP-1 Strategy Driving Competitive Edge in Obesity Clinical Research
In an interview with Applied Clinical Trials, Shipra Patel, global therapeutic area section head for endocrinology and global head of pediatrics at Parexel, discussed the evolving landscape of obesity drug development and…
GLP-1 Avexitide Continues to Show Promise in Reducing Hypoglycemia After Bariatric Surgery in Phase II Trials
Image Credit: © cacaroot – stock.adobe.com Key takeaways Phase II data show avexitide significantly reduces Level 2 and 3 hypoglycemic events in patients with post-bariatric hypoglycemia. The ongoing Phase III LUCIDITY trial…
Building Clinical Trial Infrastructure Inside Pharmacies
In a recent video interview with Applied Clinical Trials, Ramita Tandon, chief biopharma officer, Walgreens, discussed the company’s three-year milestone of leading clinical trials. Tandon highlighted several of Walgreens’ initiatives in the…
Merck Launches Phase III Trials of Once-Monthly Oral HIV PrEP Candidate MK-8527
Image Credit: © Ezume Images – stock.adobe.com Key takeaways Merck has launched the Phase III EXPrESSIVE program to evaluate MK-8527, a once-monthly oral PrEP candidate, in populations at high risk for HIV,…
KEYNOTE-689 Trial Shows Perioperative Keytruda Significantly Improves Survival in Resectable Locally Advanced HNSCC
Credit: steph photographies | stock.adobe.com Key Takeaways Perioperative Immunotherapy Boosts EFS. The KEYNOTE-689 trial demonstrated that adding neoadjuvant and adjuvant Keytruda to standard-of-care (SOC) radiotherapy significantly improved event-free survival in patients with…
Once-Weekly Efsitora Matches Daily Glargine in Type 2 Diabetes Management
Image Credit: © Proxima Studio – stock.adobe.com Key takeaways Once-weekly efsitora may streamline insulin initiation for insulin-naïve type 2 diabetes patients, with comparable glycemic control to daily glargine and reduced need for…
EMBARK Trial Shows Xtandi Combination Demonstrates Significant Overall Response in Non-Metastatic Hormone-Sensitive Prostate Cancer
Image Credit: Adobe Stock Images/MohammedElAmine Key Takeaways Xtandi plus leuprolide significantly improves overall survival: In patients with non-metastatic hormone-sensitive prostate cancer (nmHSPC) and high-risk biochemical recurrence, the combination reduced the risk of…
Arcus’ Quemliclustat Earns Orphan Drug Designation as Phase III Pancreatic Cancer Trial Advances
Image Credit: © Matthieu – stock.adobe.com Key takeaways Orphan drug designation for quemliclustat highlights regulatory momentum and unmet need in pancreatic cancer treatment development. PRISM-1 Phase III trial design reflects gold-standard methodologies…
New FDA Initiative Reveals Common Reasons for Drug Application Rejection
Image Credit: Adobe Stock Images/Tada Images Key Takeaways FDA publishes over 200 complete response letters (CRLs): The agency released CRLs from 2020 to 2024 to improve transparency and regulatory predictability in drug…
New FDA Initiative Reveals Common Reasons for Drug Application Rejection
Image Credit: Adobe Stock Images/Tada Images Key Takeaways FDA publishes over 200 complete response letters (CRLs): The agency released CRLs from 2020 to 2024 to improve transparency and regulatory predictability in drug…
How AI Teammates Will Finally Bring Us Into the Modern Era
Gaurav Bhatnagar, Chief Growth Officer, Tilda Research In an era where artificial intelligence (AI) writes poetry, self-driving cars navigate complex city streets, and algorithms predict consumer behavior with uncanny accuracy, one might…
Designing Trials Around the Full Patient Journey
In a recent video interview with Applied Clinical Trials, Heather Horville, solutions consultant, Greenphire, discussed the challenges of retention and trial timelines due to increasing financial and logistical burdens on patients. Horville…
Moderna’s mRNA-1010 Flu Vaccine Meets Efficacy Goals in Phase III Trial of Adults 50+
Image Credit: © Dr_Microbe – stock.adobe.com Key takeaways Large-Scale, Multinational Trial Design: The P304 study enrolled over 40,000 participants across 11 countries, showcasing the complexity and operational scale required for global Phase…
Removing Financial Barriers to Boost Trial Diversity
In a recent video interview with Applied Clinical Trials, Heather Horville, solutions consultant, Greenphire, discussed the challenges of retention and trial timelines due to increasing financial and logistical burdens on patients. Horville…
Final ENLIVEN Trial Results Confirm Long-Term Benefit of Turalio in Tenosynovial Giant Cell Tumor
Image Credit: © Aerial Mike – stock.adobe.com Key takeaways Long-term ENLIVEN data reinforce the value of extended follow-up in rare disease trials, especially for demonstrating durable response. Safety monitoring remains critical over…
Improving Retention in Long-Term Trials with Human-Centered Design
In a recent video interview with Applied Clinical Trials, Heather Horville, solutions consultant, Greenphire, discussed the challenges of retention and trial timelines due to increasing financial and logistical burdens on patients. Horville…
Obsolete Trial Marketing Guidelines and Missing Processes Hurt Patient Enrollment
Christine Senn, PhD, FACRP is the SVP of Site-Sponsor Innovation at Advarra Key takeaways Modernize processes for site-initiated ads: Sponsors and CROs must establish clear, timely workflows for reviewing and approving site-generated…
Removing Barriers for Underserved Patients
In a recent video interview with Applied Clinical Trials, Heather Horville, solutions consultant, Greenphire, discussed the challenges of retention and trial timelines due to increasing financial and logistical burdens on patients. Horville…
FDA Expands Farapulse PFA Approval to Persistent AF After Strong ADVANTAGE AF Trial Results
Credit: magicmine | stock.adobe.com Key takeaways The expanded FDA approval of Farapulse introduces a non-thermal ablation option for persistent AF, potentially shifting treatment pathways and protocol design. ADVANTAGE AF data reinforce the…
MariTide Shows Up to 20% Weight Loss in Phase II Trial for Obesity, Type 2 Diabetes
Credit: New Africa | stock.adobe.com Key Takeaways Up to 20% Weight Loss Achieved with Monthly Dosing. MariTide demonstrated mean weight reductions of up to 20% in participants with obesity without type 2…
The Impact of ICH E6(R3) on Biospecimen Management
With the EMA adopting ICH E6(R3) in July, sponsors with EU trial operations must now meet stricter regulations that directly impact sample management; this demands tighter data governance, risk-based approaches, and increased…
How CRO Partnerships Are Evolving to Meet Changing Industry Demands
In a recent video interview with Applied Clinical Trials, Judith Ng-Cashin, MD, chief medical officer, Novotech discussed the company’s recent accomplishment of winning the Citeline CRO Partnership of the Year Award in…
Phase III PROMINENT Trial Initiated to Evaluate Felzartamab for Primary Membranous Nephropathy
Credit: Crystal light | stock.adobe.com Key Takeaways First Phase III Trial for Felzartamab in PMN: Biogen has initiated dosing in the global PROMINENT study, evaluating the efficacy of felzartamab versus tacrolimus in…
Phase III GEMZ Trial Meets Primary Endpoint for Fenfluramine in CDKL5 Deficiency Disorder
Image Credit: © rost9 – stock.adobe.com Key takeaways Rare disease trial design requires careful structuring: The GEMZ trial’s two-part, multi-phase design highlights the complexity of running rigorous studies in low-prevalence populations like…
REDEFINE 1 Trial Finds Cagrilintide–Semaglutide Combo Delivers Over 20% Weight Loss in Majority of Patients
Credit: Daniel Krasoń | stock.adobe.com. Key Takeaways Unprecedented Weight Loss Outcomes. In the REDEFINE 1 trial, 60% of participants receiving once-weekly CagriSema (cagrilintide–semaglutide) achieved at least 20% weight loss, and 23% lost…
FDA Grants Priority Review to Merck’s sBLA for Winrevair After Early Success in ZENITH PAH Trial
Credit: samunella | stock.adobe.com Key takeaways Early trial termination for efficacy signals strong clinical benefit: The ZENITH trial was halted ahead of schedule due to overwhelming efficacy, underscoring the importance of robust…
The Next Leap in Clinical Trial Delivery
Image Credit: © putilov_denis – stock.adobe.com Key takeaways Automation must evolve into intelligence: Traditional automation has reached its limits—future-ready trials require self-adjusting, data-driven systems that can respond in real time. AI integration…
AI Levels the Playing Field in Trial Recruitment
In a recent video interview with Applied Clinical Trials, Kyle McAllister, co-founder, CEO, Trially, discussed the impact of funding cuts on underrepresented populations in medical research, emphasizing the importance of diversity-focused research….
Amgen’s Bemarituzumab-Chemotherapy Combination Significantly Improves Overall Survival in Unresectable Locally Advanced or Metastatic G/GEJ Cancer
Image Credit: Adobe Stock Images/mi_viri Key Takeaways Bemarituzumab Shows Survival Benefit: The Phase III FORTITUDE-101 trial met its primary endpoint, with bemarituzumab plus chemotherapy significantly improving overall survival in FGFR2b-positive, HER2-negative gastric…
How AI Can Ease Recruitment Burdens in Resource-Strained Trials
In a recent video interview with Applied Clinical Trials, Kyle McAllister, co-founder, CEO, Trially, discussed the impact of funding cuts on underrepresented populations in medical research, emphasizing the importance of diversity-focused research….
Using Real-World Data to Bridge the Clinical Trial Divide
Image Credit: © photon_photo – stock.adobe.com Key takeaways Clinical trial populations often don’t reflect the diversity or complexity of real-world patients, particularly in community care settings. Real-world evidence (RWE) studies are essential…
How Sites and Sponsors Are Adapting to Clinical Trial Budget Cuts
In a recent video interview with Applied Clinical Trials, Kyle McAllister, co-founder, CEO, Trially, discussed the impact of funding cuts on underrepresented populations in medical research, emphasizing the importance of diversity-focused research….
How Funding Cuts Are Undermining Patient Recruitment in Clinical Trials
In a recent video interview with Applied Clinical Trials, Kyle McAllister, co-founder, CEO, Trially, discussed the impact of funding cuts on underrepresented populations in medical research, emphasizing the importance of diversity-focused research….
Leveraging remote-based regional hubs in FSP partnerships
April 30th 2025 Article We are amidst a data revolution in healthcare and the life sciences. With advances in DNA sequencing, multiomics, wearables, imaging, and clinical data capture, there is more data…
Establishing a Bespoke Outsourcing Arrangement with Hybrid FSP/FSO Partnerships
April 30th 2025 Article We are amidst a data revolution in healthcare and the life sciences. With advances in DNA sequencing, multiomics, wearables, imaging, and clinical data capture, there is more data…
2025 FSP Trends Report
April 30th 2025 Article We are amidst a data revolution in healthcare and the life sciences. With advances in DNA sequencing, multiomics, wearables, imaging, and clinical data capture, there is more data…
Efruxifermin Shows Long-Term Promise in MASH-Related Cirrhosis Despite Missing Primary Endpoint in Phase IIb Trial
Credit: Sebastian Kaulitzki | stock.adobe.com Key Takeaways Missed Primary Endpoint at 36 Weeks. Efruxifermin did not significantly reduce fibrosis without worsening of MASH at week 36 compared to placebo, the trial’s primary…
Talvey and Tecvayli Combo Shows Strong, Durable Responses in High-Risk Multiple Myeloma with Extramedullary Disease in Phase II Trial
Credit: David A Litman | stock.adobe.com. Key Takeaways High Overall Response Rate. Talvey and Tecvayli combination achieved a 78.9% overall response rate in patients with triple-class exposed relapsed or refractory multiple myeloma…
Key Examples From ASCO 2025
Shadi Cinpinski, MHA, Director, Therapeutic Strategy, Oncology, IQVIA Jim Routt, Vice President and Unit Head, Oncology Global Therapeutic Delivery, IQVIA Jennifer Underwood, MSc, Senior Director, Therapeutic Strategy, Oncology, IQVIA Key takeaways AI…
Funding Cuts Threaten Diversity in Clinical Research
In a recent video interview with Applied Clinical Trials, Kyle McAllister, co-founder, CEO, Trially, discussed the impact of funding cuts on underrepresented populations in medical research, emphasizing the importance of diversity-focused research….
Pfizer Reports Strong Phase III Results for Hympavzi in Hemophilia Patients with Inhibitors
Image Credit: © Design Cells – stock.adobe.com Key takeaways Strong Prophylactic Efficacy: Hympavzi achieved a 93% reduction in annualized bleeding rate versus on-demand treatment in patients with hemophilia A or B with…
AI-Augmented Data, Processes, and People
Key takeaways Data and AI are redefining clinical trial operations, requiring end-to-end data strategies, trustworthy AI frameworks, and a shift toward data-centric approaches aligned with regulatory changes like ICH E6(R3). Cross-functional, digital…
STEP UP Trial Shows Higher Dose of Wegovy Produces Significant Weight Loss in Adults With Obesity Without Diabetes
Credit: Key design | stock.adobe.com. Higher-Dose Semaglutide Shows Enhanced Efficacy Key Takeaways Higher-Dose Semaglutide Shows Enhanced Efficacy. The investigational 7.2 mg dose of Wegovy (semaglutide) achieved a mean weight loss of 21%…
How AI and Machine Learning Can Improve Patient Reported Outcomes in Clinical Trials
In an interview with Applied Clinical Trials, Brian Ongioni, chief product officer, uMotif, discussed how the company actively incorporates patient and site feedback throughout the digital health product lifecycle to ensure its…
The Unsexy Plumbing of Clinical Research
Image Credit: © putilov_denis – stock.adobe.com Key takeaways Tokenization enhances real-world evidence integration: Tokenization enables researchers to securely link clinical trial data with real-world data sources such as EHRs, claims data, and…
The Importance of Early Patient Feedback in Digital Endpoint Development
In an interview with Applied Clinical Trials, Brian Ongioni, chief product officer, uMotif, discussed how the company actively incorporates patient and site feedback throughout the digital health product lifecycle to ensure its…
How Human-Centered Design Unlocks AI’s Promise in Pharma
Eric Karofsky is an award-winning CX, UX, and employee engagement industry expert who leads VectorHX, a human experience agency. Key Takeaways Human-Centered AI Design Drives Clinical Impact. AI success in pharma hinges…
Building Patient Centricity into Clinical Trial Software from Day One
In an interview with Applied Clinical Trials, Brian Ongioni, chief product officer, uMotif, discussed how the company actively incorporates patient and site feedback throughout the digital health product lifecycle to ensure its…
FDA to Launch National Priority Voucher Program to Speed Drug Reviews for Critical Therapies
Credit: Tada Images | stock.adobe.com Key Takeaways FDA fast-tracks reviews for priority drugs: The new Commissioner’s National Priority Voucher (CNPV) program reduces review times from 10–12 months to as little as 1–2…
Phase II TRANSCEND FL Shows Breyanzi Achieves Strong Efficacy, Durable Response in Relapsed Marginal Zone Lymphoma
Credit: Lisa | stock.adobe.com Key Takeaways Breyanzi Achieves High Overall Response Rate in R/R MZL. In the Phase II TRANSCEND FL trial, Breyanzi demonstrated a 95.5% overall response rate and a 62.1% complete…
Why AI and Automation Are Set to Become the New Normal in Clinical Research
At the DIA Annual Meeting, Peter Ronco, CEO, Emmes, emphasized the under-recognized but impactful role of the public sector—particularly the NIH and FDA—in advancing tech-enabled clinical development. These agencies have pioneered the…
Phase III OASIS-4 Trial Shows Elinzanetant Significantly Reduces Endocrine Therapy–Related Vasomotor Symptoms in Patients with HR-Positive Breast Cancer
Credit: steph photographies | stock.adobe.com Key Takeaways Elinzanetant Significantly Reduces Vasomotor Symptoms. Patients receiving elinzanetant experienced a statistically significant reduction in moderate-to-severe vasomotor symptoms at both four and 12 weeks compared to…
Bridging Communication Gaps to Strengthen CRO-Sponsor Collaboration
In a recent video interview with Applied Clinical Trials, Judith Ng-Cashin, MD, chief medical officer, Novotech discussed the company’s recent accomplishment of winning the Citeline CRO Partnership of the Year Award in…
Building Strong CRO-Sponsor Partnerships to Improve Clinical Trial Success
In a recent video interview with Applied Clinical Trials, Judith Ng-Cashin, MD, chief medical officer, Novotech discussed the company’s recent accomplishment of winning the Citeline CRO Partnership of the Year Award in…
Preparing Operational Teams for AI Workflows in Drug Development
At the DIA Annual Meeting, Peter Ronco, CEO, Emmes, emphasized the underrecognized but impactful role of the public sector—particularly the NIH and FDA—in advancing tech-enabled clinical development. These agencies have pioneered the…
The Truth About AI Adoption Speed in Clinical Research
At the DIA Annual Meeting, Peter Ronco, CEO, Emmes, emphasized the underrecognized but impactful role of the public sector—particularly the NIH and FDA—in advancing tech-enabled clinical development. These agencies have pioneered the…
Designing Patient Friendly Digital Health Solutions
In an interview with Applied Clinical Trials, Brian Ongioni, chief product officer, uMotif, discussed how the company actively incorporates patient and site feedback throughout the digital health product lifecycle to ensure its…
How Wearable ECGs Enhance Patient Monitoring in Drug Trials
Image Credit: © photon_photo – stock.adobe.com Key takeaways Wearable ECG devices are transforming cardiac safety monitoring by enabling continuous, real-world data collection, reducing patient burden, and improving detection of transient cardiac events…
Public Sector Sets the Pace for AI in Drug Discovery and Approval
At the DIA Annual Meeting, Peter Ronco, CEO, Emmes, emphasized the underrecognized but impactful role of the public sector—particularly the NIH and FDA—in advancing tech-enabled clinical development. These agencies have pioneered the…
How Clinical Operations Teams Are Adapting to Oncology Trial Challenges
In a recent video interview with Applied Clinical Trials, Matt Robinson, PhD, senior director, oncology research program, National Comprehensive Cancer Network (NCCN), discussed the current state and challenges of cancer patient participation…
Putting Patients at the Center of Trial Design and Decision-Making
ACT: What are some of the most exciting themes or trends in clinical research you’re looking to explore at this year’s Global Annual Meeting? Pierce: I’m starting to hear more of an…
Leveraging Technology to Enhance Cancer Clinical Trial Recruitment
In a recent video interview with Applied Clinical Trials, Matt Robinson, PhD, senior director, oncology research program, National Comprehensive Cancer Network (NCCN), discussed the current state and challenges of cancer patient participation…
Rethinking Feasibility in the Attention Economy
Hugo Stephenson, MD, Co-Founder and Executive Chair, TrialScreen Key Takeaways Eligibility ≠ participation. While many users meet trial eligibility criteria, a significant drop-off occurs when asked to provide contact information—highlighting a gap…
Detecting Fraud in Clinical Trials Using Statistical Data Monitoring
Image Credit: © Murrstock – stock.adobe.com “Identifying … potential data manipulation and data integrity problems” are an International Council for Harmonization of Technical Requirements for Pharmaceuticals for Human Use (ICH) E6 (R3)…
Phase III POETYK PsA Trials Show Significant Clinical Benefit with Sotyktu in Psoriatic Arthritis
Credit: Andrii | stock.adobe.com Key Takeaways Sotyktu Meets Primary Endpoint in POETYK PsA-1 Trial. In the Phase III POETYK PsA-1 trial, 54.2% of patients receiving Sotyktu achieved an ACR20 response at week…
Science is Moving—Clinical Trials Must Catch Up
Allison Cuff Shimooka, Chief Operating Officer, TransCelerate BioPharma Key Takeaways Clinical trial processes lag behind scientific and technological advances. While the science and tools exist to run faster, more inclusive, and efficient…
What Actually Moves the Needle on Inclusive Research
Rebecca Johnson, PhD, Clinical Research Recruitment and Inclusion Executive and Strategist Key Takeaways Progress toward inclusive trials without mandates. Even before federal mandates such as FDORA (2022), stakeholders across industry, academia, and…
Empowering Clinicians to Communicate Clinical Trial Opportunities Effectively
In a recent video interview with Applied Clinical Trials, Matt Robinson, PhD, senior director, oncology research program, National Comprehensive Cancer Network (NCCN), discussed the current state and challenges of cancer patient participation…
Navigating the Intersection of Accessibility and Measurement Integrity in eCOA
Over the last half a century or so, clinical research has progressively shifted from a somewhat paternalistic focus on physiological or surrogate endpoints such as biomarkers or imaging, toward the inclusion of…
Understanding the Challenges Preventing Cancer Patients from Joining Trials
In a recent video interview with Applied Clinical Trials, Matt Robinson, PhD, senior director, oncology research program, National Comprehensive Cancer Network (NCCN), discussed the current state and challenges of cancer patient participation…
Preparing to Achieve with Joint Clinical Assessments
Graham Bell Director, Global Regulatory Strategy, ICON plc Key Takeaways Joint Clinical Assessment is now a parallel requirement under HTAR.Health technology developers must prepare for a JCA alongside EMA or notified body…
The Urgent Need to Boost Cancer Patient Enrollment in Clinical Trials
In this video interview, Matt Robinson, PhD, senior director, oncology research program, National Comprehensive Cancer Network (NCCN), discusses the persistent challenges of low cancer patient enrollment in clinical trials and why broader…
First Patient Dosed in Phase III Trial of Enhertu as First-Line Treatment for Endometrial Cancer
Image Credit: © LASZLO – stock.adobe.com Key takeaways Phase III Trial Explores Enhertu Combo in Endometrial Cancer: DESTINY-Endometrial01 is assessing Enhertu with rilvegostomig or Keytruda vs. chemo plus Keytruda in HER2-expressing, pMMR…
CONFIDENCE Trial Demonstrates Superior Outcomes With Kerendia and Jardiance Combination in CKD and T2D
Credit: Crystal light | stock.adobe.com Key Takeaways Early Combination Therapy Achieves Superior UACR Reduction. Simultaneous initiation of Kerendia (finerenone) and Jardiance (empagliflozin) led to a 52% reduction in urine albumin-to-creatinine ratio (UACR)…
Exploring Perspectives of Fair Market Value in Clinical Trial Budgeting
Image Credit: © putilov_denis – stock.adobe.com Key takeaways Transparent FMV practices are critical: Open and collaborative FMV calculations help build trust and reduce negotiation friction among sponsors, CROs, and sites. Flexibility drives…
Phase III MATTERHORN Trial Shows Imfinzi Combo Significantly Improves Event-Free Survival in Resectable Gastric and GEJ Cancers
Credit: Crystal light | stock.adobe.com. Key Takeaways First Immunotherapy to Achieve Statistically Significant EFS in Resectable Gastric and GEJ Cancers. Imfinzi (durvalumab) combined with FLOT chemotherapy significantly improved event-free survival (EFS) versus…
Rethinking Clinical Trial Efficiency Amidst Cost Pressures on Pharma
In a recent video interview with Applied Clinical Trials, Jim Kremidas, executive director, Association for MultiSite Research Corporations (AMRC), discussed the Trump Administration’s ‘Most Favored Nation’ pricing policy for pharmaceuticals, which aims…
Enhancing Obesity Trials with Integrated eCOA and Digital Endpoint Technologies
Join us for an insightful session IQVIA experts Anthony Mikulaschek and Michael Bruhns will share their experience on harnessing the power of eCOA and digital endpoint collecting devices to advance obesity trials….
Accelerating Site Activation and Recruitment with MCRC Partnerships
In a recent video interview with Applied Clinical Trials, Jim Kremidas, executive director, Association for MultiSite Research Corporations (AMRC), discussed the Trump Administration’s ‘Most Favored Nation’ pricing policy for pharmaceuticals, which aims…
Phase III IRAKLIA and Phase II IZALCO Trials Support Sarclisa On-Body Delivery for Relapsed/Refractory Multiple Myeloma
Credit: Saiful52 | stock.adobe.com Key Takeaways On-body delivery system (OBDS) proves non-inferior to IV Sarclisa in multiple myeloma treatment. Data from the Phase III IRAKLIA trial showed that subcutaneous Sarclisa administered via…
Otsuka’s Sibeprenlimab Demonstrates Meaningful Outcomes in Phase III Study for Immunoglobulin A Nephropathy
Image Credit: © Crystal light – stock.adobe.com Key takeaways Promising interim results support APRIL inhibition as a viable IgAN strategy: Sibeprenlimab achieved a 51.2% reduction in proteinuria at 9 months, marking a…
Lessons from a Multicentric Study in India
Image Credit: © photon_photo – stock.adobe.com Key takeaways Early regulatory engagement prevents delays: Proactively managing protocol amendments and aligning with regulatory authorities in advance can significantly reduce startup timelines in oncology trials….
CARTITUDE-1 Trial Shows Carvykti Achieves Durable, Treatment-Free Remissions in Relapsed or Refractory Multiple Myeloma
Image Credit: Adobe Stock Images/freshidea Key Takeaways Carvykti Delivers Long-Term Remission: One-third of patients in the CARTITUDE-1 trial achieved at least five years of treatment-free survival after a single CAR T-cell therapy…
How Trump’s Most Favored Nation Policy Could Impact Funding for Clinical Development
In a recent video interview with Applied Clinical Trials, Jim Kremidas, executive director, Association for MultiSite Research Corporations (AMRC), discussed the Trump Administration’s ‘Most Favored Nation’ pricing policy for pharmaceuticals, which aims…
HHS Cancels Moderna Grant for Late-Stage Development of mRNA Vaccine Candidate
Image Credit: © Tada Images – stock.adobe.com Key takeaways HHS has pulled a $590M grant from Moderna’s H5N1 mRNA flu vaccine, citing scientific and ethical concerns. Despite this, Moderna reported strong immune…
Phase III BREAKWATER Trial Shows Braftovi-Based Regimen Improves Survival in BRAF V600E-Mutant Metastatic Colorectal Cancer
Credit: Sebastian Kaulitzki | stock.adobe.com Key Takeaways First-Line Survival Milestone in BRAF V600E mCRCThe Braftovi (encorafenib) combination regimen is the first to show a statistically significant and clinically meaningful overall survival benefit…
Tecentriq and Zepzelca Combo Demonstrates Significant Survival Benefit in Phase III Study for Extensive-Stage Small Cell Lung Cancer
Image Credit: © iDoPixBox – stock.adobe.com Key takeaways Tecentriq plus Zepzelca significantly improved both PFS and OS in ES-SCLC maintenance therapy versus Tecentriq alone. IMforte’s design showcases the value of seamless transition…
How FDA Cuts Are Creating New Bottlenecks in Clinical Operations
In a recent video interview with Applied Clinical Trials, Ron Lanton, partner, Lanton Law, discussed the impact of drug cost increases on clinical research, predicting a reduction in government-sponsored trials due to…
AstraZeneca and Daiichi Sankyo Share Positive Data From Phase III DESTINY-Breast09 Trial of Enhertu Plus Pertuzumab
Image Credit: © Crystal light – stock.adobe.com Key takeaways Enhertu plus pertuzumab showed a 44% reduction in disease progression or death versus the current standard-of-care THP regimen. The combination therapy achieved a…
Realtime Electronic Data Capture at Investigator Sites: Laboratory Data and Beyond
Introduction Paper-based data capture has been the standard in clinical trials since their inception. In the 1990s, the FDA kicked off the digital era in clinical trials with their Computer-Assisted New Drug…
Clinical Trial Monitoring: Should Randomization Be Included?
Jennifer Ross, director of biostatistics, and Kevin Venner, group leader, biostatisticians; both with Almac Clinical Technologies Developing a clinical trial’s effective monitoring plan can be overwhelming. The FDA acknowledges that while they…
Investigational MK-1084 Demonstrates Antitumor Activity in Phase I Trial for Colorectal and Non-Small Cell Lung Cancers
Image Credit: © Dr_Microbe – stock.adobe.com Key takeaways Early-phase trial design should anticipate combination therapy pathways, as seen with MK-1084 across multiple arms. Safety and tolerability remain primary endpoints, even when exploring…
The Hidden Impact of Drug Pricing on Government Clinical Trials
In a recent video interview with Applied Clinical Trials, Ron Lanton, partner, Lanton Law, discussed the impact of drug cost increases on clinical research, predicting a reduction in government-sponsored trials due to…
Daiichi Sankyo and Merck Pull Back Patritumab Deruxtecan BLA Based on Phase III HERTHENA-Lung02 Outcomes
Image Credit: © Sebastian Kaulitzki – stock.adobe.com Key takeaways BLA withdrawn due to lack of OS benefit: The Phase III HERTHENA-Lung02 trial failed to meet its overall survival endpoint, prompting BLA withdrawal….
How to Stay Agile in a Fast-Moving Clinical Trial Ecosystem
© photon_photo – © photon_photo – stock.adobe.com. Key takeaways AI and tech expertise are becoming core clin ops requirements: Success increasingly depends on integrating AI, predictive analytics, and advanced data tools—requiring teams…
Pimicotinib Succeeds in Phase III MANEUVER Trial, Demonstrates Meaningful Improvements in Tenosynovial Giant Cell Tumor Patients
Image Credit: © Aerial Mike – stock.adobe.com Key takeaways Strong ORR validates trial design and execution: The trial achieved a 54% objective response rate vs. 3.2% for placebo, marking the highest ORR…
Gilead’s Trodelvy Meets Primary Endpoint of Progression-Free Survival in Phase III ASCENT-03 Breast Cancer Study
Image Credit: © Crystal light – stock.adobe.com Key takeaways Trodelvy achieves primary endpoint in first-line mTNBC: The ASCENT-03 Phase III trial demonstrated a statistically significant and clinically meaningful improvement in PFS for…
AI-Powered Predictions and Virtual Patient Models
In a recent video interview with Applied Clinical Trials, Michel van Harten, MD, CEO, myTomorrows, discussed the integration of artificial intelligence (AI) in clinical trials, highlighting its potential to reduce costs, accelerate…
New Phase III Data Show Bayer’s Nubeqa Significantly Improves Quality of Life for Prostate Cancer Patients
Image Credit: © Dr_Microbe – stock.adobe.com Key takeaways Quality of life metrics matter in mCSPC trials: Post-hoc ARANOTE data shows that Nubeqa + ADT significantly delays deterioration in HRQoL, including social, functional,…
A Disruption in the Clinical Research Enterprise
In a recent video interview with Applied Clinical Trials, Michael Liu, medical student and researcher at Harvard Medical School, discussed a recent study on National Institutes of Health (NIH) grant cuts. Among…
Monitoring NIH Funding Cuts
In a recent video interview with Applied Clinical Trials, Michael Liu, medical student and researcher at Harvard Medical School, discussed a recent study on National Institutes of Health (NIH) grant cuts. Among…
Bridging Innovation and Trust with Artificial Intelligence
In a recent video interview with Applied Clinical Trials, Michel van Harten, MD, CEO, myTomorrows, discussed the integration of artificial intelligence (AI) in clinical trials, highlighting its potential to reduce costs, accelerate…
Nerandomilast Meets Primary Endpoints in Phase III IPF and PPF Trials, Shows Significant Lung Function Preservation
Credit: mi_viri | stock.adobe.com Key Takeaways: Nerandomilast Phase III Trial Data Nerandomilast Demonstrates Statistically Significant FVC Preservation in IPF and PPFIn both the FIBRONEER-IPF and FIBRONEER-ILD Phase III trials, nerandomilast achieved the…
How AI Lowers the Real-World Barriers to Trial Participation
In a recent video interview with Applied Clinical Trials, Michel van Harten, MD, CEO, myTomorrows, discussed the integration of artificial intelligence (AI) in clinical trials, highlighting its potential to reduce costs, accelerate…
ARCHES and ENZAMET Trials Confirm Long-Term Xtandi Efficacy in Metastatic Hormone-Sensitive Prostate Cancer
Credit: Dr_Microbe | stock.adobe.com. Key Takeaways: Xtandi in mHSPC Long-Term Survival Confirmed. Five-year results from the Phase III ARCHES trial show a 30% relative improvement in overall survival (OS) with Xtandi (enzalutamide)…
Harnessing Technology and Adopting Unified Approaches to Optimize Pharmacovigilance Activities
Image Credit: © NicoElNino – stock.adobe.com Key takeaways Digital intake must be the default to ensure quality and efficiency: Prioritizing digital-first adverse event intake—tailored to the reporter’s persona—improves data quality and reduces…
Roche’s Susvimo Lands FDA Approval for Diabetic Retinopathy Based on Phase III Pavilion Trial Data
Image Credit: © Pixel-Shot – stock.adobe.com Key takeaways Susvimo sets a new standard for long-acting ophthalmic treatments: With FDA approval for a refill interval of nine months, Susvimo offers a breakthrough in…
The Role of AI in Solving Clinical Trial Diversity and Access Challenges
In a recent video interview with Applied Clinical Trials, Michel van Harten, MD, CEO, myTomorrows, discussed the integration of artificial intelligence (AI) in clinical trials, highlighting its potential to reduce costs, accelerate…