BMJ  2004;329:285 (31 July), doi:10.1136/bmj.329.7460.285

Commentary

Better support for investigators is essential

Sarah Meredith, clinical epidemiologist1

1 MRC Clinical Trials Unit, London NW1 2DA sm@ctu.mrc.ac.uk

The first 150 words of the full text of this article appear below.

Wald's description of his encounter with the new research ethics committee forms provides a graphic illustration of the frustration and bemusement of most researchers when faced with the hurdles that must now be surmounted to conduct a clinical trial.1 As well as the expansion in the volume of paperwork, the need to understand and comply with the regulatory requirements for good clinical practice, reporting of adverse events, and the supply and labelling of trial drugs make it almost impossible for a clinician to undertake a clinical trial without support. This is not necessarily a bad thing if it leads to better quality studies that are safer for patients, but training and support must be funded and provided if clinical trials in the public interest are to continue.

Wald was unfortunate to be initiating a clinical trial in the transitional period before all the systems to implement the new clinical trials . . . [Full text of this article]


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