Image Credit: Andy Studna In a session at the 2024 DIA Global Annual meeting in San Diego, CA, Jane Myles, program director, Decentralized Trials and Research Alliance (DTRA); Joseph Unger, PhD, MS,…
Category: Medicine
Rob DiCicco of TransCelerate Biopharma Discusses the State of AI in Clinical Research
ACT: What do you think are some of the greatest opportunities for integrating artificial intelligence (AI) into clinical research? DiCicco: I think there are a couple of different ways to look at…
Pat Hughes of CluePoints Highlights Renewed Agreement With FDA, Utilizing AI in RBQM
ACT: What are you looking forward to working on and achieving with FDA under the renewed CRADA agreement? Hughes: We are so delighted to renew the agreement with the FDA; our cooperative…
Challenges and Opportunities for Industry Sponsors
Image credit: wladimir1804 | stock.adobe.com Introduction The increasing focus on diversity in clinical trials by regulatory authorities worldwide, combined with the ongoing need to expand pools of eligible patient participants, is leading…
Lokavant Launches Artificial Intelligence Clinical Trial Feasibility Solution
Image Credit: © Kaikoro – stock.adobe.com Lokavant has announced the launch of an artificial intelligence (AI) clinical trial feasibility software solution, Spectrum. According to Lokavant, the solution is the first of its…
Investigational COVID-19 Vaccine Shows Non-Inferior Efficacy vs. Spikevax in Phase III Trial
Image credit: rost9 | stock.adobe.com Findings from the Phase III NextCOVE (NCT05815498) trial of Moderna’s mRNA-1283 showed the next-generation, investigational SARS-CoV-2 vaccine achieved the primary efficacy endpoint of non-inferiorty vs. Spikevax (mRNA-1273)…
FDA Grants Accelerated Approval to Bristol Myers Squibb’s Augtyro for the Treatment of NTRK-Positive Locally Advanced or Metastatic Solid Tumors
Image Credit: Adobe Stock Images/Oksana Smyshliaeva The FDA has granted accelerated approval to Bristol Myers Squibb’s (BMS) Augtyro (repotrectinib), a tyrosine kinase inhibitor (TKI), for treating adult and pediatric patients over 12…
Elrexfio Shows Deep and Durable Responses Extending Survival in Relapsed or Refractory Multiple Myeloma
Image credit: LASZLO | stock.adobe.com Findings from the Phase II MagnetisMM-3 trial (NCT04649359) showed a significant survival benefit with Elrexfio (elranatamab-bcmm) in patients with heavily pretreated relapsed or refractory multiple myeloma (RRMM).1…
Improving Quality of Care for Cancer Patients
ACT: How can we improve shared decision-making practices as ways to improve the quality of care for cancer patients? Buyse: Again, I think the method that we advocate and use at One2Treat,…
EQT Acquires Majority Stake in CluePoints
Image Credit: © lidiia – stock.adobe.com EQT has announced that the EQT Healthcare Growth Strategy and the EQT Growth Fund have agreed to acquire a majority stake in CluePoints. The management team…