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

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

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Authors: A summary of an article written by Dr Aaron Koshy and Professor Andrew L Clark

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.

‘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

A summary of the article’s key learning points

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.