Compulsory registration of clinical trials: Publicly funded national register of trials would be best in the United Kingdom

BMJ 2004; 329 doi: https://doi.org/10.1136/bmj.329.7473.1043-b (Published 28 October 2004) Cite this as: BMJ 2004;329:1043
  1. Lesley Stewart, head, meta-analysis group (Lesley.Stewart{at}ctu.mrc.ac.uk),
  2. Claire Vale, clinical trials manager, UK National Register of Cancer,
  3. Janet Darbyshire, director
  1. MRC Clinical Trials Unit, London NW1 2DA
  2. MRC Clinical Trials Unit, London NW1 2DA

    EDITOR—We support the statement of the International Committee of Medical Journal Editors on trial registration discussed by Abbasi,1 2 but we reiterate that currently no register satisfies all requirements.

    The UK National Register of Cancer Clinical Trials meets the criteria in that it is freely available, managed by a not for profit organisation, and stores all required data items. It is, however, restricted to UK randomised cancer trials. Setting national and disease boundaries has enabled an in-depth approach whereby we are confident that we have captured most publicly funded trials. Passively providing a database for registration does not work. Trials need to be actively sought and managed. A high proportion of our registrations are effected by our register manager seeking permissions and abstracting information from protocols; thereafter, we actively seek updated accrual and publication information. To move beyond this, while maintaining comprehensiveness, undoubtedly requires an element of compulsion.

    The database of the International Standard Randomised Controlled Trial Number Register and the utility of a unique numbering system has undoubtedly progressed the registration argument. However, it has not solved the problem: registration is voluntary, and for some organisations, even a modest cost of number purchase is a disincentive.

    We are also aware that those conducting trials are increasingly burdened by administration, and many feel they are already “registering” their trials in many different places. So far the response to registration has been piecemeal, and we need a coordinated approach, both nationally and internationally. We believe that in the United Kingdom, the best approach would be to build a publicly funded national register of trials, using a similar model to clinicaltrials.gov, but which operates across all interventions and areas of health care. Backed by legislation or obligation of governance that all trials conducted in the UK should be entered in this particular register, this could lead to the first ever fully comprehensive register of trials. Perhaps the recently created UK Clinical Research Collaboration will rise to the challenge of pursuing this.


    • Competing interests None declared.


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