Protocol Design Featured Articles
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Is Osteoarthritis Cure — ARPA-H NITRO — Rocket Fuel Or TNT?
8/21/2023
The U.S. federal government just unveiled a moonshot to fix osteoarthritis. Rumored to be funded at $1 billion and launched out of the new Advanced Research Project Agency for Health (ARPA-H), the Novel Innovations for Tissue Regeneration in Osteoarthritis, or NITRO program, plans to cure OA in five years. But can it be done?
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How To Design A Clinical Trial Protocol With Patient And FDA Collaboration
8/18/2023
On a recent episode of Clinical Leader Live!, a panel of seasoned drug developers sat down to discuss the quintessential do’s and don’ts of modern clinical trials.
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The Dos and Don’ts Of Patient Centricity
8/15/2023
New, exciting methodologies like DCTs and wearables can improve patient centricity, but only when participants’ lifestyles and preferences are kept in mind.
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Drug Development Must Meet Complex, Diverse Needs Of The Opioid Use Disorder Community
8/7/2023
With almost 80,000 opioid overdose deaths in 2022, the surge in opioid-related overdoses and deaths in the United States has continued at a relentless pace. Treatments are available, but with more diverse therapies and flexible trial designs, more patients will be able to begin their journey to recovery.
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How Can Non-randomized RWE Studies Complement RCTs?
8/4/2023
While RWE can provide deep insights into the drug development process, inform regulatory decisions, and supplement clinical research, it does have its limitations. Researchers with the RCT-DUPLICATE Initiative have emerged with key learnings to further inform the industry on the capabilities of RWE.
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Gilead Addresses Health Equity In HIV Prevention Challenges By Designing Next-Gen Clinical Trials, Aiming For New Options
8/3/2023
Despite progress being made toward global HIV elimination goals, HIV transmission persists, and pre-exposure prophylaxis (PrEP) uptake is lower than desired. In the U.S. alone, only 20% of people who would benefit from PrEP actually take it. Gilead Sciences aims to improve uptake by developing new preventative medicines and implementing novel trial designs, starting with its PURPOSE program.
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Diversifying Site Location, Trial Design, & Community Partnerships To Drive Diversity In Clinical Trials
8/2/2023
Creating a diverse and equitable clinical trial requires strategic planning and careful execution — and a balanced approach. Experts at Mirati Therapeutics show how intentional site selection, trial design, and community relationships result in more diverse patient populations for clinical research.
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6 Tips For Collaboration In Rare Disease Clinical Research
7/28/2023
What does it mean to truly collaborate within industry in clinical research, particularly as it relates to advancing cures for rare disease? Baylor University Medical Center Program Director for the Department of Internal Medicine Ankit Mehta, MD, shares six ways clinical research professionals can better work alongside each other.
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Study Participant Consenting — Can We Do A Better Job?
7/24/2023
Informed consent documents (ICDs) can be long and complicated, for consenting patients, for auditors, and, sometimes, for regulators. So what can be done to make them better? Guest expert Kamila Novak shares real-life examples of ICDs gone wrong and a few ways to make things right.
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Why Do So Many Alzheimer’s Clinical Trials Fail?
7/19/2023
Over the past 20 years, 98% of Alzheimer’s disease treatment clinical trials have failed. But why? INmune Bio CEO and Chief Medical Officer RJ Tesi, MD explores what he says are the three main reasons why so few AD clinical trials succeed.