Denise Bronner Ph.D., director of diversity, equity, and inclusion in clinical trials at Johnson & Johnson Innovative Medicine (JJIM) talks about some of the types of datasets that can be leveraged to improve diversity in clinical trials.
The absence of clear biological indicators for fatigue makes diagnosing and finding effective treatments difficult. Cambridge Cognition's Michele Veldsman, Ph.D. is working to develop better biomarkers to improve diagnosis, care, and treatment.
Amylyx’s head of global clinical development Lahar Mehta, MD, talks multi-stakeholder trial design, purposeful site selection, the importance of caregiver burden, and the benefits of an open label extension (OLE).
Having been a clinical research professional (CRP) for almost 25 years, Teri Crumb, MSN, RN, CRCC, has seen both operational transformation and stagnation. Here, she looks back — and into the future — asking, "What if?"
Bayer added three Phase 3 trials to its MOONRAKER clinical development program for the study of Kerendia (finerenone) as a potential treatment for heart failure. Overall, the goal for the program is to enroll 15,000 participants.
Are Institutional Review Boards (IRBs) and Independent Ethics Committees (IECs) the same? And if they're not, how are they different? Kamila Novak of KAN Consulting helps define the two bodies and their roles across the globe, as well as explains how we might rethink their roles in the future.
Steven Devine, MD, chief medical officer of National Marrow Donor Program (NMDP)/Be The Match, discusses theimpact of cryopreservation on hematopoietic stem cell (HSC) grafts and its implications for clinical trials.
Navigating the intersection of rare disease research in a patient population of pregnant individuals can be tricky. Janssen, however, is taking the challenge head on with its Phase 2 clinical trial of nipocalimab for the treatment of pregnant individuals at high risk for early-onset severe hemolytic disease of the fetus and newborn (HDFN). Katie Abouzahr, MD discusses the nuances of enrolling pregnant participants in clinical trials and considerations for future maternal-fetal disease research.