Abstract
BackgroundThis paper highlights the issues that one of the 90 Italian Research Ethics Committees (RECs) might encounter during the approval phase of a clinical trial to identify corrective and preventive actions for promoting a more efficient review process and ensuring review quality. Publications on the subject from Italy and the rest of Europe are limited; encouraging constructive debate can improve RECs’ service to the subject of the clinical trial.MethodsWe retrospectively reviewed a cohort of 822 clinical trial protocols, initially reviewed by REC, from June 2014 to December 2018. Data collected for each protocol were type of trial, sample size, use of placebo, number and kind of revisions requested by the REC before approval, and time taken for approval. Data for each protocol were collected by a trained clinical research assistant using the REC’s files and electronic archives.ResultsAlmost 45% of the reviewed studies (374/822) required clarifications, significant changes to the documentation, or minor changes before final approval.ConclusionsPreventive measures are needed to reduce the number of requested corrections and thus also the time required for approval, while maintaining review quality. All critical points and proposals presented in this paper require harmonization through updates to European regulations, as regulatory harmonization produces better compliance with rules and reduces the number of changes required before the trials’ final approval. Such updates include the development of standardized formats for informed consent, the verification of any evidence in favor of using off-label treatments over placebo as comparators, using multidisciplinary staff in clinical trials with children and adolescents, improving the legal definition of RECs to assign responsibilities and ensure independence, and providing guidance for RECs to engage clinical research assistants in internal audits.
Highlights
This paper highlights the issues that one of the 90 Italian Research Ethics Committees (RECs) might encounter during the approval phase of a clinical trial to identify corrective and preventive actions for promoting a more efficient review process and ensuring review quality
Only 20 of the 822 protocols were rejected by the REC, 17% of studies required more than one re-evaluation, due to necessary clarifications and significant changes to the documentation, while 34% were approved with minor changes before the final approval
We suggest that quality support for RECs could be a useful path to attract promoters to clinical centers and, at the same time, emphasize the ethical expertise required by the REC, ensuring the patient’s best interest and promoting the ever-needed change in the regulation
Summary
This paper highlights the issues that one of the 90 Italian Research Ethics Committees (RECs) might encounter during the approval phase of a clinical trial to identify corrective and preventive actions for promoting a more efficient review process and ensuring review quality. Publications on the subject from Italy and the rest of Europe are limited; encouraging constructive debate can improve RECs’ service to the subject of the clinical trial. A clinical trial (CT) may be initiated if a Research Ethics Committee (REC) and/or competent authority decides that anticipated therapeutic and public health benefits. While many studies have evaluated the structure, process, and outcome of the Institutional Review Board (IRB) review in the United States and have documented inconsistencies and inefficiencies there [4], little research. The study was conducted in accordance with the ethical principles specified in legally and non-legally binding instruments covering biomedical research related to protocol evaluation during the REC approval phase
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