Protocol Design Featured Articles
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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.
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4 Pitfalls Of Poor-Performing Clinical Trial Teams — And How To Prevent Them
9/25/2023
Sudden teammate departure? Unexpected shift in strategy? Learn about the four common pitfalls (related to communications and team expectations) of clinical operations teams — and how to avoid them — with these pointers from consultant Monica Roy.
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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.
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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.
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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.
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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.
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Use PBPK Modeling To Design More Accurate Clinical Trials
9/5/2023
The data gained via PBPK modeling has the potential to produce a more effective and less burdensome trial experience for patients while saving resources for sponsors.
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What You Need To Know About The New ICH GCP E6(R3) Draft Guidelines
8/31/2023
The ICH’s updated draft guidelines for planning, designing, conducting, recording, and reporting clinical trials introduce a dynamic, risk-based approach to trial design and create universal standards for data.
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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.
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What To Include In (And What To Leave Out Of) Your Clinical Trial Protocol
8/23/2023
To create a trial protocol that adequately captures your data requirements in a simple and streamlined fashion, consult early and often with patients and regulators to leverage their perspective.