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Strategies to Maximize Patient Participation in Clinical Trials
Eric H Rubin1, Mary J Scroggins1, Kirsten B Goldberg1
1From the Merck Research Laboratories, North Wales, PA; Pinkie Hugs, LLC, Washington, DC; U.S. Food and Drug Administration, Silver Spring, MD.
Abstract:
Despite considerable interest and success in oncology drug development, the minority of patients with cancer diagnoses enroll in clinical trials. Multiple obstacles account for this low enrollment rate. An improvement in patient participation in clinical trials could increase patient access to novel and potentially promising agents, provide faster trial results, and, with implementation of rational eligibility criteria, allow for a better understanding of the drug's safety and efficacy in a heterogeneous population. We present barriers and potential solutions to maximize patient participation, including a review of the ASCO and Friends of Cancer Research (FoCR) Modernizing Eligibility Criteria Project, U.S. Food and Drug Administration (FDA) regulatory considerations, an industry perspective, and a patient perspective.
Insights
Low patient enrollment in cancer clinical trials hinders drug development. Addressing barriers to participation can improve access to novel therapies and accelerate research findings for better cancer treatment outcomes.
Area of Science:
- Oncology
- Clinical Trials
- Drug Development
Background:
- Despite advances in oncology drug development, patient enrollment in clinical trials remains low.
- Numerous obstacles contribute to the limited participation of cancer patients in clinical research.
Purpose of the Study:
- To identify barriers to patient participation in oncology clinical trials.
- To propose solutions for maximizing patient enrollment and improving trial efficiency.
Main Methods:
- Review of the ASCO and Friends of Cancer Research (FoCR) Modernizing Eligibility Criteria Project.
- Consideration of U.S. Food and Drug Administration (FDA) regulatory perspectives.
- Inclusion of industry and patient viewpoints on trial participation.
Main Results:
- Identified key obstacles hindering patient enrollment in cancer clinical trials.
- Outlined strategies to enhance patient access to novel cancer therapies.
- Highlighted the importance of rational eligibility criteria for understanding drug safety and efficacy.
Conclusions:
- Improving patient participation in clinical trials is crucial for advancing cancer care.
- Collaborative efforts involving regulatory bodies, industry, and patients can overcome enrollment barriers.
- Optimized clinical trial participation leads to faster research outcomes and better patient access to innovative treatments.
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