Cardiovascular research 2018 handbook:
How to apply to do a clinical trial

doi:10.5837/bjc.2018.s11 Leave a comment
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Sponsorship Statement: This handbook was initiated and funded by Novartis. Editorial control, however, was retained by the authors/presenters and editors. Novartis reviewed the handbook for technical accuracy only before publication.
Date of preparation: August 2018.
CVM18-R012

Conducting clinical research is an ambition of many cardiologists and academic clinicians. Over the past decade, the NHS has indicated that research is a clear priority in improving healthcare for patients. The processes leading to permission to start a clinical trial in the UK are, however, often poorly understood, and can be labyrinthine (figure 2), lengthy and fraught with difficulty. To share their knowledge of how to start a clinical trial, two investigators wrote an article for the BJC (doi:10.5837/bjc.2016.007) about the different organisations involved and about the essential documents and communication required using a case study to illustrate the various stages of the process.

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‘The NHS has indicated that research is a clear priority in improving healthcare for patients’

Figure 1. The case trial timeline, intervals are in days

CV research applications

    A summary of the article’s key learning points

CV research applications

  • Obtaining approval for conducting clinical research can be an extremely lengthy endeavor (see figure below). The process makes a four-month term in research almost useless, unless you begin the application process at least nine months in advance of a trial’s expected start date. You will need more than a year if you are applying for external funding.
  • Work closely with the relevant organisations, particularly the R&D department of your Trust, the Research and Ethics Committee and the Medicines Health Research Agency to reduce the risk of avoidable errors and delay.
  • A robust study protocol is essential for a successful application and trial.
  • Be guided by your academic supervisor: his/her advice is invaluable.
  • Complete the online or face-to-face Good Clinical Practice (GCP) course offered by the National Institute of Health Research. It improves your understanding of clinical research. Successful completion of a GCP course is mandatory for those conducting clinical trials.
  • Be ready to learn. You will acquire many skills during the application process: patience and endurance; effective communication and time management; critical appraisal; appreciation of ethical issues and patient safety.
  • To be successful, the investigators have to communicate their capacity to manage potential complications, complete the trial and present the results of a relevant, well-designed study.

Figure 2. The complexity of a clinical trial: good practice requirements in blue and legal requirements in red. An informative pathway found on www.ct-toolkit.ac.uk/routemap

The complexity of a clinical trial: good practice requirements in blue and legal requirements in red. An informative pathway found on www.ct-toolkit.ac.uk/routemap

Articles in the handbook

1. Introduction
2. National Institute for Health Research
3. Optimising clinical research using electronic medical records
4. Recent research at the Institute of Cardiovascular Medicine and Science
5. Clinical trials in the UK from a commercial perspective
6. Brexit: threat or opportunity
8. Useful organisations

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