Featured Clinical Leader Editorial
-
Establishing TMF Quality Goals For Greater Trial Efficiency
9/14/2023
Does your clinical development group rely on its TMF as a resource for designing and conducting trials efficiently? Would maintaining timeliness in filing complete, ALCOA-compliant documents to the TMF be enough if efficiency were a goal of every clinical trial? Consultant Ken Keefer discusses the importance of creating TMF quality goals to improve overall trial performance.
-
Pursuing Smaller, Faster Clinical Trials For Progressive Neurological Disorders
9/11/2023
Current progression measures of neurodegenerative disease are clinically focused, highly subjective, and can take years to reveal the effects of therapeutic intervention. Knowing that, the pursuit of smaller and faster clinical trials, particularly at the proof-of-concept stage, can be an innovative way to counteract some risks and sidestep the limitations of larger trials.
-
Vulnerable Populations Need Safer, More Effective COVID-19 Antivirals
9/8/2023
Although COVID-19 is no longer a public health emergency, elderly and immunocompromised individuals remain vulnerable to severe outcomes. Drug developers, therefore, must adapt to deliver next-gen oral antivirals through clinical trials that incorporate the lessons we have learned during the pandemic and address the needs of these high-risk patients.
-
What Do You MENA? The Arab World And Its Opportunities For Clinical Research
9/6/2023
Looking beyond the imperative of involving more Arab Americans in clinical trials, there’s more to be said about involving the Middle East and North Africa (MENA) region in clinical research. Arab Board of Clinical Research Chair and President Hadi Danawi, Ph.D. explores the challenges to and benefits of conducting clinical trials in this underserved region.
-
Biomarkers, E-Diaries, & Enrollment: Lessons Learned From An E-cigarette Cessation Trial
8/29/2023
Six percent of American adults reported using e-cigarettes in 2022, and many would like to quit. Achieve Life Sciences is aiming to help them do just that and is sharing details of its trial design, implementation, and lessons learned from a evaluating a novel e-cigarette cessation therapy, including how to prepare for the unlikely over-enrollment of a trial.
-
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?
-
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.
-
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.
-
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.
-
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.