Article Text
Abstract
Research Ethics Committees (RECs) play a critical gatekeeping role in clinical trials. This role is meant to ensure that only those trials that meet certain ethical thresholds proceed through their gate. Two of these thresholds are that the potential benefits of trials are reasonable in relation to risks and that trials are capable of producing a requisite amount of social value. While one ought not expect perfect execution by RECs of their gatekeeping role, one should expect routine success in it. This article reviews a range of evidence showing that substantial numbers of ethically tainted trials are receiving REC approvals. Many of the trials are early phase trials that evidence shows have benefits that may not be reasonable compared with their risks and many others are later trials that evidence shows may lack sufficient social value. The evidence pertains to such matters as methodologically inadequate preclinical studies incapable of supporting the inferences that REC members must make about the prospects for potential benefit needed to offset the risks in early phase trials and sponsorship bias that can cause improperly designed, conducted, analysed and reported later phase trials. The analysis of the evidence makes clear that REC practices need to be strengthened if they are to adequately fulfil their gatekeeping role. The article also explores options that RECs could use in order to improve their gatekeeping function.
- drugs and drug industry
- regulation
- research ethics
- scientific research
This is an open access article distributed in accordance with the Creative Commons Attribution Non Commercial (CC BY-NC 4.0) license, which permits others to distribute, remix, adapt, build upon this work non-commercially, and license their derivative works on different terms, provided the original work is properly cited, appropriate credit is given, any changes made indicated, and the use is non-commercial. See: http://creativecommons.org/licenses/by-nc/4.0/.
Statistics from Altmetric.com
Footnotes
Funding A portion of the author’s time was supported by the National Center for Advancing Translational Sciences, National Institutes of Health, through Grant Number UL1 TR001860.
Disclaimer The content is solely the responsibility of the author and does not necessarily represent the official views of the NIH.
Competing interests None declared.
Provenance and peer review Not commissioned; externally peer reviewed.
Other content recommended for you
- Assessing risk/benefit for trials using preclinical evidence: a proposal
- Mapping the preclinical to clinical evidence and development trajectory of the oncolytic virus talimogene laherparepvec (T-VEC): a systematic review
- Study protocol for a randomised controlled trial of enhanced informed consent compared to standard informed consent to improve patient understanding of early phase oncology clinical trials (CONSENT)
- A Plutocratic Proposal: an ethical way for rich patients to pay for a place on a clinical trial
- Moving towards less biased research
- Large scale clinical trials: lessons from the COVID-19 pandemic
- Early phase clinical trials extension to guidelines for the content of statistical analysis plans
- Protocol for the systematic review of the reporting of transoral robotic surgery
- Research made simple: ethics committee approval
- Dementias Platform UK Clinical Studies and Great Minds Register: protocol of a targeted brain health studies recontact database