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How to set up a clinical trial
  1. Rachel A B Thomas1,
  2. Emma Louise Aitken2,
  3. Jean Antonelli3,
  4. Lorna Marson1,4
  1. 1The Edinburgh Transplant Centre, Royal Infirmary of Edinburgh, Edinburgh, UK
  2. 2Transplant Surgery, Queen Elizabeth University Hospital, Glasgow, UK
  3. 3Edinburgh Clinical Trials Unit, The University of Edinburgh, Edinburgh, UK
  4. 4QMRI, The University of Edinburgh, Edinburgh, UK
  1. Correspondence to Dr Rachel A B Thomas, The Edinburgh Transplant Centre, Royal Infirmary of Edinburgh, Edinburgh EH16 4SA, UK; rab_thomas{at}hotmail.co.uk

Abstract

Clinical trials are considered the gold-standard method for the evaluation of healthcare interventions. However, randomised control trials are complex to perform and many researchers, especially those in the early stages of their career, can find it challenging to know where to start set up, contribute to or lead a trial. This guide provides an introduction to trials and also practical advice to help potential investigators complete their clinical trial to time and to budget by signposting the pathway through the complex regulatory landscape. The authors draw on their own recent experiences of running clinical trials and provide tips and tricks for troubleshooting common problems encountered including trial design and documentation.

  • statistics & research methods
  • clinical trials
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Footnotes

  • Twitter Rachel A B Thomas @rab_thomas

  • Contributors RT was responsible for writing the bulk of the manuscript. EA assisted in writing the manuscript and producing the figures. RT, EA, JA and LM were all responsible for revising the manuscript. LM has overall oversight for the work.

  • Funding The authors have not declared a specific grant for this research from any funding agency in the public, commercial or not-for-profit sectors.

  • Competing interests All authors have completed the ICMJE uniform disclosure form at www.icmje.org/coi_disclosure.pdf.

  • Patient consent for publication Not required.

  • Provenance and peer review Not commissioned; externally peer reviewed.

  • Author note Resources like the new NIHR Clinical Trials Register provide excellent information for patients, however there is limited practical information for new researchers starting out in the concept stage of a clinical trial. Both RT and EA have been involved in the design, initiation and management of high impact clinical research studies in recent years as clinical trainees. At the outset, we struggled to find simple, relevant help and advice geared to the UK clinical trial system and our article could bridge the deficit. Subsequently, we have been approached by and provided support for other junior researchers endeavouring to navigate the clinical trials paperwork and legislation. We have written this article in an attempt to address their questions. Given the rapidly increasing number of investigator-led clinical trials in the UK, we believe such practical advice will have far-reaching demand among professionals and also the general public. All of the authors have experience of successfully setting-up, running and coordinating clinical trials, the results of which have been published in Lancet and Transplantation. RT and EA are full-time clinicians who have acted as CI and PI in multiple clinical trials. JA is employed as a Clinical Trials Manager in the Edinburgh Clinical Trials Unit. LM is a Professor of Transplantation with extensive experience in running clinical trials. She acts as guarantor for the article.

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