Preparing for what the reporting checklists will not tell you: The PREPARE trial guide for planning clinical research to avoid research waste

Thomas Bandholm, Robin Christensen, Kristian Thorborg, Shaun Patrick Treweek, Marius Henriksen

Research output: Contribution to journalArticle

14 Citations (Scopus)

Abstract

Poor planning of clinical trial research may lead to a trial that is too hard to do, irrelevant, or both, leading to wasted research efforts. Planning of a trial is as important as running or analysing it, since flaws or mistakes made in the conception or planning phase cannot always be rectified, once the trial starts. We contend that early career researchers and PhD students in their research training do not have easy access to information on how to plan clinical trial research for success.

It is the aim of the PREPARE Trial guide to provide information to assist in the preparation and planning of clinical trial research. The intent is to inform preparatory decisions prior to the start of the trial, instead of “putting out fires” later on.

The guide describes key steps in the initial trial pathway and presents related key literature, which covers: formulating the research question, objective, and hypothesis; initial pilot or feasibility studies to inform a full-scale trial; writing the protocol using the SPIRIT checklist; registering the trial, and publishing the protocol. The emphasis is to convey tacit information and complex knowledge on practical issues that are not readily available (and thus not easily transferable) in existing protocol or reporting checklists, such as SPIRIT and CONSORT.

We intend for the PREPARE Trial guide to be used by early career researchers who are about to undertake their first research, or by experienced PhD-supervisors, trialists, and lecturers as preparation for research meetings, or curriculum for courses on research methodology.
Using the PREPARE Trial guide could lead to enhanced research quality and reduced research waste.
Original languageEnglish
Pages (from-to)1494-1501
Number of pages8
JournalBritish Journal of Sports Medicine
Volume51
Issue number20
Early online date7 Sep 2017
DOIs
Publication statusPublished - Oct 2017

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Keywords

  • clinical trial
  • methods
  • research design
  • clinical protocol

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