Efficient management of randomised controlled trials: nature or nurtureBMJ 1998; 317 doi: https://doi.org/10.1136/bmj.317.7167.1236 (Published 31 October 1998) Cite this as: BMJ 1998;317:1236
- Barbara Farrell, trial manager (Barbara.Farrell@ndm.ox.ac.uk)
- Institute of Health Sciences, Oxford OX3 7LF
- Accepted 5 October 1998
A randomised controlled trial sets out to do just one thing—to discover the truth. Pick up any medical journal, and you can read about the need for a good randomised clinical trial to answer a burning clinical question. A trial that will inform, enhance, and, when applicable, change clinical practice. Experienced research committees prioritise the clinical questions that need answering to ensure the health of the nation. They also set guidelines on what constitutes good clinical practice within a research context.1 Furthermore, the scientific and clinical communities ensure that good scientific modelling is central to trial methodology. How a trial actually happens and how the conclusions that affect clinical practice are arrived at are often less prescribed.
Little is written about the day to day and strategic management of such trials. There are no clearly defined operational models established or any code of practice for managing a randomised controlled trial. The apparent lack of recognition for the role of efficient management in the effective delivery of a trial needs to be addressed. Randomised controlled trials need to be managed like any other organisation. Many clinical trials fail to deliver because of the lack of a practical businesslike approach to getting the job done.
Although the scientific validity of a randomised controlled trial is subject to intense scrutiny, the actual management of the trial often receives little attention
The knowledge and expertise gained on running earlier trials are not widely disseminated, so new trials are begun from scratch
Trials need to be marketed properly to ensure that sufficient numbers of participating centres and patients are recruited
For the day to day running of the trial, robust systems and procedures must be designed that are efficient, effective, and flexible (generic models that can be customised)
A trial team is needed for …