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Promise: A review of protocols of clinical trials to summarise what types of evidence are currently used for demonstrating the promise of an intervention
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Description: Increasingly funders are asking researchers to provide evidence of 'promise' (or 'evidence the intervention can work') when submitting bids for randomised controlled trials (RCTs) or feasibility studies of interventions. To avoid research waste, it is important to establish that an intervention has some promise before proceeding with a series of expensive clinical research studies that may be unwarranted if an intervention has little or no effect on patient outcomes. There is no shared understanding among stakeholders about what constitutes ‘promise’, and what study designs and research methods are appropriate for 'promise' studies. Nor is it clear whether it is appropriate to undertake 'promise' research alongside or separately from feasibility and pilot studies. This uncertainty leads to research waste, as expensive studies may be performed on unpromising treatments, while promising treatments may not be pursued. Guidance is needed on how to evaluate the promise of an intervention, to ensure that effective interventions are introduced in an efficient fashion. Other terms used to describe ‘promise’ are ‘proof of concept’ and ‘evidence of efficacy’. This review represents the second stage in a project (the Promise study) aiming to develop guidance on how to define, report, and evaluate ‘promise’, and will review protocols for clinical trials to understand what research designs for ‘promise’ are reported by applicants. The first stage was a review to examine what funders at looking for in terms of ‘promise’ (Stage 1 protocol - OSF Registries | Promise: A review of research funder guidance relating to promise of the intervention). Subsequent stages will develop guidance on suitable research designs and methods for 'promise' in clinical research, to guide relevant stakeholders, including researchers, funders and research users. Part of the scope of the Promise study is to define ‘promise of the intervention’. Here, we adopt an inclusive working definition, which includes any evidence presented by the protocol authors intended to suggest that there is likely to be a benefit of the intervention.
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