• Press Office

    Posted in category News Release by Press Office on 07/12/2006

    Revised guidelines on Phase 1 trials to follow Duff Report

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


‚ÄčThe 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. 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.
  • Medical science moves on, and it is important that our guidelines covering studies in non-patient volunteers are up-to-date," said Dr Richard Barker, Director General of the ABPI.
  • While there are many more aspects to consider than the quite exceptional events surrounding the TGN1412 trial, it is clearly essential that we take on board the recommendations of Professor Gordon Duff's inquiry."

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

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.

For further information, please contact: ABPI Press Office 020 7747 1410

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