Clinical trials risk: a new assessment tool

Abstract

Purpose

Risk management is becoming an increasingly important topic in healthcare. The dangers of conducting clinical trials were brought to the attention of the public by the media in 2006 with the TGN1412 phase 1 clinical trial. Clinical trials are however important for the development of new drugs. There are a number of gatekeepers for the safety of trials but risk assessment is now becoming an important aspect. This paper aims to focus on clinical trials.

Design/methodology/approach

A new risk assessment tool was developed to collect data relating to the contributory factors and control measures associated with clinical trials. The responses to a series of 29 questions are then scored to inform a risk rating for the clinical trial

Practical implications

The theoretical model was converted into a Microsoft Excel spreadsheet with drop down boxes for the responses to the questions. Research management staff have found the tool simple and quick to use. A printout of the assessment can be placed in the study folder as evidence. Highlighted risks are then flagged up to the organisation's corporate risk register and an action plan developed.

Originality/value

The tool has been utilised to assess risks of all research projects from educational studies such as MSc, PhD to medical device trials and drug trials. Furthermore it has assessed risks in the acute, primary care and mental health sectors.

Citation

Brown, A.S. (2011), "Clinical trials risk: a new assessment tool", Clinical Governance: An International Journal, Vol. 16 No. 2, pp. 103-110. https://doi.org/10.1108/14777271111124455