Introduction

For the early career researcher or PhD student about to have a leading role in a clinical trial, it would be a tremendous help to have a ‘How to’ guide, consisting of advice and key literature to help the researcher move successfully along the initial trial pathway from research question to protocol completion. While the ideal trial team should include experienced trialists, who participate in the preparatory research meetings, this support is not always available. The PREPARE Trial guide is intended to assist the early career researcher in this situation, but not replace an experienced trial team and regular research meetings. The guide may also serve as preparation for research meetings, or part of curricula for courses on research methodology, to be used by experienced PhD supervisor, trialist or lecturer.

Evidence from randomised controlled trials (RCTs) is often wasted1 2 (for a collection of papers relating to this issue, please see http://researchwaste.net/). Many trials are not published, and hence the results are not reported, which is indeed a waste. There are many reasons for this waste, but we believe that at least some trials are discontinued because of poor trial planning. Similarly, many completed and published trials suffer from fundamental flaws or poor conduct due to lack of preparation and careful planning. Some flaws in the conception or planning phase prior to the finalised trial protocol and registration are difficult to rectify once the trial starts. For example, patients may decline participation if the study involves delaying or withholding treatment, or if the experimental condition is deemed unfeasible by patients. This can be avoided, for example, by involving patients in the planning of the trial or by conducting pilot or feasibility studies prior to the full-scale trial. In many cases, the planning of a trial is as least as important as …