As the ISRCTN trial registermanaged by Current Controlled Trials (CCT) now includes over 10,000 trial records, a new article published in the Journal of Evidence-Based Medicine goes back over the achievements of the past 8 years and the challenges ahead, in the field of public trial registration.
Since 2003 the ISRCTN dataset neededto best describe a trial has been expanded in line with international guidelines developed by the World Health Organization and the International Committee of Medical Journal Editors, to cater for the needs of the scientific community and the general public. In June 2011, a lay summary field was added to the register to ensure that clinical trial information is presented in lay-friendly terms to increase trial awareness and participation. Guidance notes have also been produced.
There is no legal requirement to publicly register clinical trials in the UK. The ISRCTN register has always been positioned as open to registration for all study designs, in all areas of health care, from all countries. From
over 90% in the early years, the UK now contributes fewer than 55% of all the trials registered. A recent example of the ISRCTN register’s ongoing collaboration with the Department of Health in England is its participation in the launch of the UK Clinical Trials Gateway in March 2011.
The ISRCTN registeralso provides the first step in the concept of BioMed Central’s threaded publications, enabling the tracking of clinical research studies from inception and the linking of all resulting publications including the raw data where this is available.
The remaining challenges include making sure that more trials are publicly listed, high quality is maintained, and processes are developed to strengthen links between all the components of a study.