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Pirates of Clinical Trials

Medicine and Health

Pirates of Clinical Trials

J. P. Jr, C. Pergolizzi, et al.

The escalating operational dynamics of clinical trials have led to fierce competition for research subjects, raising ethical concerns and financial pressures for contract research organizations. Authored by Joseph Pergolizzi Jr, Claudio Pergolizzi, and Ann K Lequang, this paper delves into the challenges of subject recruitment and proposes innovative solutions to enhance trial integrity and inclusivity.... show more
Abstract
With the burgeoning numbers of clinical trials, the competition among sponsors for research subjects has grown intensely. Many clinical trials fail to meet their recruitment goals. Contract research organizations (CROs) that help conduct all or portions of a clinical study have transitioned from highly specialized niches, such as biostatistical analysis or regulatory compliance, to more overall functions to keep a trial moving forward. CROs establish agreements with sponsors, including how much a site will be paid per study subject. CROs are locked into that pricing, but over the course of a study's recruitment period, sponsors with deeper pockets may step in and offer more compensation per subject. The result is a competitive market place that favors big sponsors and puts smaller CROs and start-ups at a disadvantage.
Publisher
Cureus
Published On
Oct 27, 2023
Authors
Joseph Pergolizzi Jr, Claudio Pergolizzi, Ann K Lequang
Tags
clinical trials
contract research organizations
subject recruitment
ethical concerns
financial pressures
decentralized trials
digital twins
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