When clinical trials compete: prioritising study recruitment

Abstract

It is not uncommon for multiple clinical trials at the same institution to recruit concurrently from the same patient population. When the relevant pool of patients is limited, as it often is, trials essentially compete for participants. There is evidence that such competition is a predictor of low study accrual, with increased competition tied to increased recruitment shortfalls. But there is no consensus on what steps, if any, institutions should take to approach this issue. In this article we argue that an institutional policy that prioritizes some trials for recruitment ahead of others is ethically permissible and indeed prima facie preferable to alternative means of addressing recruitment competition. We motivate this view by appeal to the ethical importance of minimizing the number of studies that begin but do not complete, thereby exposing their participants to unnecessary risks and burdens in the process. We then argue that a policy of prioritization can be fair to relevant stakeholders, including participants, investigators, and funders. Finally, by way of encouraging and helping to frame future debate, we propose some questions that would need to be addressed when identifying substantive ethical criteria for prioritizing between studies.

A Framework for Assessing Scientific Merit in Ethical Review of Clinical Research

“…Knowledge of a large, ongoing trial (e.g., the anacetrapib CVD trial, which was designed to enroll approximately 30,000 patients; see figure S1) should factor into an ethics committee’s evaluation of study value. Since trials may compete to recruit patients, these other ongoing activities in a portfolio of research can represent obstacles to timely recruitment and trial completion 37 . If there are many competing trials, ethics committees may wish to request clarification from investigators about their plans for recruitment.…”

Against pandemic research exceptionalism

“…They should instead seek out opportunities to join larger, carefully orchestrated protocols to increase the prospect that highquality studies will be completed quickly and generate the information needed to advance individual and public health. Academic medical centers can facilitate such coordination by surveying the landscape of ongoing studies and establishing mechanisms for "prioritization review" to triage studies (14). The goal would be to incentivize participation in efforts that uphold the criteria outlined here and to foster robust participation in multicenter studies so that data can be generated from different institutions before their capacity to meet fastidious research requirements is overwhelmed by surging medical demand.…”

The limits of research institutions in setting research priorities

“…If each institution makes independent decisions about how to prioritise among the studies they host, we would not expect those priorities to align. Indeed, Gelinas et al 6 suggest that institutional self-interest may lead research institutions to prioritise studies for which they are the main site over studies for which they are not. Even if no self-interested motivations were in play, as the number of institutions involved in a given study increased, the likelihood that at least one institution would postpone recruitment for that study would grow.…”