Month: September 2024

Credit: abdelaziz@771 | stock.adobe.com Carvykti (ciltacabtagene autoleucel) was found to produce a significant improvement in overall survival (OS) in patients with relapsed or lenalidomide-refractory multiple myeloma, according to long-term data from the Phase…

Credit: Saiful52 | stock.adobe.com Bristol Myers Squibb (BMS) and 2seventy bio announced the discontinuation of enrollment in the Phase III KarMMa-9 trial (NCT06045806) evaluating Abecma (idecabtagene vicleucel) in newly diagnosed multiple myeloma (NDMM)…

ACT: How can the integration of real-world data (RWD) reduce burden for key stakeholders in a trial such as sites, sponsors, and patients? Gliklich: I believe that the research paradigm is rapidly…

This webinar, hosted by Avacare Clinical Research Network, will provide a comprehensive understanding of why clinical trial diversity matters and the key barriers that impede diverse participation. We will explore actionable strategies…

ACT: What are some key regulatory requirements or challenges that need to be addressed when using real-world data (RWD)? Gliklich: Before I dive into what’s good and bad, I would say that…

Credit: GoodIdeas | stock.adobe.com Findings from the Phase III REGENCY trial (NCT04221477) demonstrated that Gazyva/Gazyvaro (obinutuzumab; Roche) in combination with standard therapy of mycophenolate mofetil and glucocorticoids achieved the primary endpoint of…

Image Credit: © NicoElNino – stock.adobe.com As the field of clinical research undergoes rapid evolution, so too must the methodologies employed to safeguard patient participants. Whereas the focus of recent decades was…

Image Credit: © Blue Planet Studio – stock.adobe.com Medidata has announced the launch of its newest solution, Patient Payments. Headlined by the use of automation, this offering aims to streamline trial-related stipends…

Results from the ADjoin long-term extension study (NCT04392154) show that more than 80% of patients with moderate-to-severe atopic dermatitis (AD) who responded to treatment with Ebglyss (lebrikizumab-lbkz) in the ADvocate 1 and…

Image Credit: © Jakub Krechowicz – stock.adobe.com While cancer affects all demographics, there is a noticeable difference in burden within underrepresented populations. According to the National Cancer Institute, there are a number…

Credit: photon_photo | stock.adobe.com Clinical trial advertisements are a significant way through which prospective patients learn about and act upon clinical trial participation opportunities. During the recruitment phase of a clinical trial,…

ACT: How important is the role of real-world data (RWD) in clinical research for cancer and other rare diseases? Gliklich: When I think about real-world data, I think both in terms of…

Credit: gpointstudio | stock.adobe.com Results from the Phase II AGAVE-201 trial (NCT04710576) show that (Niktimvo) axatilimab monotherapy is effective and safe in the treatment of patients with recurrent or refractory chronic graft-versus-host-disease…

ACT: You have an upcoming session on “Transforming Clinical Trials: From Reactive to Predictive.” What are some of the main points that will be discussed during the session? Baara: I’ll be talking…

ACT: Is there any potential for the use of AI when it comes to decision-making and enrollment? Lwoff: In the trial development process, AI algorithms can analyze existing data to predict trial…

DPHARM’s “Aligning Innovations to Solve the Big Problems in Clinical Trials in a Resource-Constrained Environment” session When it comes to addressing pain points in the clinical trial space, many would agree that…

DPHARM’s “How Pharma is Shifting Operating Models for More Efficient Clinical Trials” session Sometimes, the innovation in things is to just stop and simplify. DPHARM 2024 carried on with a leadership panel…

Image credit: freshidea | stock.adobe.com Findings from the Phase III NIAGARA trial (NCT03732677) show that Imfinzi (durvalumab) in combination with chemotherapy significantly improved event-free survival (EFS) and overall survival (OS) compared to…

Image credit: THITIPORN | stock.adobe.com Results from the Phase III CABINET trial (NCT03375320) demonstrated that cabozantinib (Cabometyx, Cometriq) produced a significant improvement in progression-free survival (PFS) compared to placebo in patients with…

Matt Cooper, PhD is an Executive Director and Therapeutic Strategy Lead, Oncology, at Worldwide Clinical Trials Jim Eamma is an Executive Director and Therapeutic Strategy Lead, Oncology, at Worldwide Clinical Trials As…

ACT: You hosted a session on how to “Unlock the Power of the Patient for Better Patient Recruitment Outcomes.” What was the premise of the presentation? Pellegrino: It was talking about a…

DPHARM’s “How Do You Make Scaling eSource EHR a Reality?” session Along its “New Approaches to Scale eSource EHR and Accelerate Clinical Development” track, Day 2 of DPHARM welcomed a presentation that…

ACT: What are some key considerations sponsors should be mindful of when aligning their decision-making process with the timeline of a trial? Lwoff: Ultimately, understanding the need to have some flexibility with…