Clinical trials guidelines revised in wake of TGN1412

Industry guidelines on the conduct of clinical trials in human volunteers are being revised in the wake of the inquiry by Professor Gordon Duff.

The Association of the British Pharmaceutical Industry (ABPI) had already started work, before the TGN1412 trial occurred, on producing new guidelines, which will be completed in consultation with other, relevant organisations, to replace those that have set the industry standard for many years.

The ABPI and the BIA jointly established a special task force to provide expert input to the inquiry, and its report was published earlier in the year. The ABPI will be examining the final report of the inquiry in detail. A full analysis of the inquiry's recommendations will now be carried out to ensure that all relevant points are included.

The guidelines cover all aspects of clinical trials - including those relevant to the very small number of compounds that act in a similar way to TGN1412. Areas to be covered by the new document will include:

• Justification for volunteer studies and the assessment of risk.
• Recruitment of volunteers.
• Ensuring participants in trials do not volunteer for too many studies
• and defining those groups of people who would not normally be included.
• Safeguards and the suitability of facilities.
• Design and protocol of such studies.

The revised guidelines will be made available on a global basis to regulatory authorities, trade associations and other interested parties.