BMJ  2005;330:479-480 (26 February), doi:10.1136/bmj.330.7489.479-b

Letter

More on compulsory registration of clinical trials

GSK has created useful register

EDITOR—The editorial by Abbasi and letters in response illustrate the considerable interest in the registration of clinical trials.^{1 2} As a pharmaceutical company that has created a register to communicate the results of clinical trials of our marketed products, GlaxoSmithKline would like to bring to your attention the decisions we have taken to make our register worthwhile and meaningful to the medical profession and others with an interest in clinical research.

The GSK Clinical Trial Register is comprehensive: it will include the results from all GSK sponsored clinical trials (phases I-IV) of marketed medicines conducted anywhere in the world. The results include primary and secondary efficacy end points defined in trial protocols, and a summary of adverse events beyond what is traditionally reported in publications. This information is reported in the format of the International Conference on Harmonisation E3 guideline, a standard that will enable comparison across registers and, in time, possibly be brought together in consolidated registers.

We stand ready and willing to work with others to establish an international register for trials that are initiating patient enrolment, as called for by the International Committee of Medical Journal Editors.³ In the meantime, we have started to register all GSK sponsored patient trials that we initiate on www.clintrials.gov, as we have for trials of serious and life threatening illness. These postings will identify GSK as the sponsor and will include directions for patients interested in becoming trial subjects. We will include the National Library of Medicine number in our results register and scientific publications.

GSK is committed to ensuring that our results register and our posting of trials initiating enrolment are comprehensive. To that end, we are establishing a means of independent compliance assessment of our activities and assembling an international advisory board.

The GSK Clinical Trial Register, along with a description of its operating principles, is available at http://ctr.gsk.co.uk.

GlaxoSmithKline, Upper Merion, PA 19087, USA

frank.w.rockhold{at}gsk.com GlaxoSmithKline, Upper Merion, PA 19087, USA

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Competing interests: RK and FR are employees of GlaxoSmithKline.

References

1. Abbasi K. Compulsory registration of clinical trials. BMJ 2004;329: 637-8 (18 September).[Free Full Text]
2. Correspondence. Compulsory registration of clinical trials. BMJ 2004;329: 1043-4. (30 October.)[Free Full Text]
3. Clinical trial registration: a statement from the International Committee of Medical Journal Editors. JAMA 2004;292: 1363.[Free Full Text]

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