Protocol Design Featured Articles
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Electronic Data Capture In Clinical Trials: What Needs To Improve?
11/14/2023
Integrated technologies enhance clinical trial support, boosting the potential for quicker time-to-market. Key sponsors and CROs favoring operational efficiency prioritize "holistic study design," involving the integration of technologies (e.g., EDC, eCOA, and IRT) aligned with protocol, as opposed to constructing the study in individual tools.
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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.
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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.
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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.
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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.
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Accelerated Approval, Sponsor Alliances, Master Protocols: Three Ways To Increase Odds Of Regulatory Approval
9/29/2023
As drug sponsors work to ensure FDA and ex-U.S. approval, further exploring how to design integrated master protocols across multiple sponsors could yield major advantages for patients.
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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.
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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.
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Why Clinical Trials In The APAC Region Cost Less
9/26/2023
Clinical trials in APAC countries cost 30%-40% less than in other regions, making the area very attractive to pharmaceutical and biotech companies looking to conduct efficient, high-quality global trials.
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Finding Biomarkers With Clinical Benefit And FDA Appeal For Neurodegenerative Diseases
9/26/2023
By identifying biomarkers that will be supported by the FDA, sponsors increase their chances of designing a successful trial protocol, gaining FDA approval, and delivering their drugs to patients.