Featured Clinical Leader Editorial

1. Identifying Digital Endpoints For Fatigue To Drive Better Clinical Care And Treatments 11/28/2023

   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.

2. How Pfizer Prioritizes Diversity When Implementing Multiple Myeloma Trials 11/21/2023

   Every patient deserves the chance to feel seen, heard, and prioritized in research and care — and for Black individuals with multiple myeloma, it’s a matter of urgency. 

3. Trial Site Selection And Design Insights For Neurodegenerative Diseases 11/16/2023

   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).

4. “What If” Musings From A 25-Year CRP 11/15/2023

   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?"

5. Bayer Launches Investigator-Sponsored Collaborative Studies 11/10/2023

   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.

6. Do We Need An IRB/IEC Revolution? 11/10/2023

   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.

7. What COVID-19 Taught Us About Fresh Vs. “Frozen” Allogeneic HSC Grafts 10/20/2023

   Steven Devine, MD, chief medical officer of National Marrow Donor Program (NMDP)/Be The Match, discusses the impact of cryopreservation on hematopoietic stem cell (HSC) grafts and its implications for clinical trials.

8. Lessons Learned Navigating First-In-Human Trial For Pediatric, LMIC Patients 10/19/2023

   Seth Bogner, chairman and CEO of HeartPoint Global, discusses HeartPoint Global’s first-in-human clinical trials and the challenges and opportunities that come with it. 

9. Pregnancy In Clinical Trials: Janssen Accepts The Challenge, Sees Value Beyond Maternal-Fetal Health 9/28/2023

   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.

10. Enabling “Good” Clinical Research In LMICs With The Good Clinical Trials Collaborative 9/27/2023

    Guided by the five scientific and ethical principles described in the Good Clinical Trials Collaborative's Guidance for Good RCTs, Good Trials Prism aims to enhance the quality of clinical research in Latin America, Southeast Asia, and South Africa by prioritizing collaborative, informative, and efficient research responses to pressing public health issues.