Clinical trial safety committees: the devil's spoon
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Pharmaceutical industry sponsored clinical research should be run independently with an independent data monitoring and safety committee overseeing trials, argues Professor John Hampton in a personal paper in this week's BMJ.
Doctors working in the pharmaceutical industry must contend with the competing demands of drug development and patient safety, says the author and this situation, he suggests, was borne out in the British Biotech affair, which showed the pharmaceutical industry "at its worst". Hampton details what happened at British Biotech and how in the best interests of the patients involved, Dr Andrew Millar, the director of clinical research at the company, blew the whistle on drug trials that were not going as well as the company directors had claimed.
To avoid this situation, Hampton suggests that the pharmaceutical industry "must be kept at arm's length from the development of its own drugs". He concludes that a means of achieving this is the appointment of a data monitoring and safety committee which could protect patients (both those included in a trial and those with the disease in question) and could ensure the integrity of the study, yet have no other responsibility to the pharmaceutical sponsors.
Contact:
Professor John Hampton, Professor of Cardiology, Division of Cardiovascular Medicine, Queen's Medical Centre, Nottingham
Tel: +44 (0)115 970 9346
Fax: +44 (0)115 970 9384
Email: John.Hampton@nottingham.ac.uk