Pirates of Clinical Trials

The increasing number of clinical trials has created intense competition among sponsors for research subjects, often jeopardizing the scientific rigor of investigations. Contract research organizations (CROs), initially specialized in niche functions, now play a broader role in trial management. However, the system allows sponsors with greater financial resources to outbid others, creating a competitive marketplace that disadvantages smaller CROs and start-ups. This paper explores the challenges of subject recruitment, highlighting the ethical concerns of international trials, and the financial pressures faced by CROs due to this competitive bidding process. The authors propose potential solutions, including broader educational interventions, stronger site integrity, and the exploration of decentralized trials and digital twins.

Joseph Pergolizzi Jr, Claudio Pergolizzi, Ann K Lequang