The Association of the British Pharmaceutical Industry is to establish a voluntary
register of clinical trials conducted in the United Kingdom.
The register will be established on January 1, 2001. Pharmaceutical companies
will be encouraged to include details of all phase III or IV trials that include
UK subjects. The aim is to register trials within three months of a new medicine
receiving marketing authorisation in a country considered to be a major market.
The details to be included are: company name; trial number; title; design and
methodology; types of patient included and excluded; sample size; start and
finish dates; contact information; and publication status.
The trial register will be set up and housed by the Centre for Medicines Research
International, an ABPI sister company, but it will be the responsibility of
pharmaceutical companies to register and update trials. The new system will
be linked via the internet to other trial registers already in existence, including
those maintained by the Cochrane Collaboration, and will be available at www.controlled-trials.com.
Speaking at a press conference in London on October 3 to launch the register,
Dr Richard Tiner (medical director, ABPI) said that knowing which studies had
been conducted would allow better meta-analyses to be carried out and improve
horizon scanning exercises. The register would, he hoped, also reduce duplication
of clinical trials and multiple publication of results.
Sir Iain Chalmers (director, UK Cochrane Collaboration centre) welcomed the
new register, which he said would help reduce publication biases in favour of
positive trials. Currently, these trials were more likely to be published or
presented than negative or equivocal trials. The establishment of the register,
together with work within the industry on guidelines for good publication practice,
was an important step in the right direction.
Asked whether phase III trials should be registered prospectively, ie, before
product registration, Dr Trevor Jones (director general, ABPI) said that there
were issues of commercial sensitivity in publishing such information. Sir Iain
said that it was right to press the industry on this matter.