Clinical trials conducted in the UK on new medicines and sponsored by the pharmaceutical industry are to be placed on a public database - the first of its kind in the world - under a voluntary scheme announced by the Association of the British Pharmaceutical Industry (ABPI) today. The scheme will start at the beginning of 2001.

The scheme will mean that authoritative details of the clinical trials sponsored by the pharmaceutical industry will be available to researchers, healthcare professionals, patient groups and other interested parties for the first time.

The aim is to register details of clinical trials relating to a new medicine within three months of its having been registered in a major market. The database will also flag up in advance trials to be conducted, after licensing approval among, NHS patients.

The main advantage of the scheme is that it will provide a single, comprehensive reference point for researchers. The scheme will also mean fewer duplications of basically similar trials and avoid results from the same trial being published many times, thus leading to confusion.

"The UK-based pharmaceutical industry is the first in the world to take this step," said Dr Richard Tiner, Medical Director of the ABPI. "I am delighted that, for the first time, this country is going to have a large but, above all, accurate database of clinical trials work that will be readily available to those who need it."

Dr Iain Chalmers, Director of the UK Cochrane Centre, and Professor Richard Lilford, NHS Trials Advisor, both endorsed the scheme.

"The fact that the British pharmaceutical industry has followed the excellent lead given by Glaxo Wellcome and Schering Healthcare towards greater openness is a real milestone. It should be welcomed by patients, practitioners, policy makers and researchers," said Dr Chalmers.

Information that will be available will include:

• The design and methodology of the study.
• Details of the number of patients included in a trial, including which groups of patients have been included and which excluded
• Details of the length of the trial, including the start and finish dates.
• Contact details for further information about the clinical trials.

The new database will be held by CMR International, an independent scientific unit. In the past, a number of industry-sponsored trials carried out within the NHS have been placed on the National Research Register, but information is sometimes inaccurate or incomplete.

"While it is right and proper that we should get the new database established - and it will clearly take time to achieve this - the ABPI will be considering whether the scheme could be extended at some point to cover clinical trials that are taking place as well as those that have been completed," said Dr Tiner.

The scheme will be introduced on January 1, 2001, although two ABPI member companies, Glaxo Wellcome and Schering Healthcare, have already been providing information on clinical trials for two years or more. The UK is the first country in the world to announce such a comprehensive scheme, covering the entire industry.

The site can be accessed via the Internet on www.controlled-trials.com and will be open to anyone to access. There is a registration procedure.