Table 1 Types of reviews for clinical trials
From: A maturity model for the scientific review of clinical trial designs and their informativeness
Review type | Definition |
|---|---|
Pre-funding peer review | Researchers, academics, and scientists—recruited by funders to volunteer their efforts—assess applications from their peers that solicit funding for clinical studies. This evaluation, performed by experts external to the funder, is “used to decide whether studies will be funded” [7,8,9] |
Regulatory review | “An investigation of the proposed CT protocol to assess whether the CT will expose subjects to unnecessary risks, qualifications of investigators, commitments to obtain informed consent, intent to both gain approval from an independent review board and comply with drug regulations” [10]. Alternately, “assessment and validation of the submitted regulatory documents, assessment of study protocol, scientific evidence to show the product is safe for the study, the risk and benefits of patients’ participation in the study; qualification of the study team, commitment to follow regulatory and Good Clinical Practice guidelines and to protect participants, and ensuring ethical clearance has been achieved.” (communication, Dr. Beno Yakubu, Nigeria Agency for Food & Drug Administration, April 16, 2022) |
Ethical/bioethical review | Joint consideration by expert group members on a CT’s ability to follow best practices in seven areas: “respect for subjects, informed consent, independent review, favorable risk–benefit ratio, fair subject selection, social and clinical value, and scientific validity” [11]. “The process must assess risk–benefit in areas such as participant consent, confidentiality, data security, minimizing harms to participants; in return for patient risk, the study must conform to scientific principles, and take into account the existing body of evidence, and make a contribution to generalizable knowledge” [12,13,14] |
Scientific design review | An evaluation focused on study protocol details that estimates and describes risks of not achieving statistically sound and meaningful results—such a review must evaluate biostatistical methods, question formulation, inclusion and exclusion criteria, commonality of endpoints, site selection, prudence of prevalence and effect assumptions, and more, without focus on generic good clinical practice, ethics, and regulatory topics that will be covered by others. A research unit wrote “[our] protocol review monitoring committee is the scientific review panel, responsible for ensuring the scientific merit and rigor of the protocol, while the Institutional Review Board ensures that the study is ethical and safe” [15, 16] |