JRSM > Volume 99, Number 9 > Pp. 435

This Article Full Text (PDF) Send a Quick Comment Alert me when this article is cited Alert me when Quick Comments are posted Alert me if a correction is posted Services Email this article to a friend Similar articles in this journal Similar articles in PubMed Alert me to new issues of the journal Download to citation manager Citing Articles Citing Articles via Google Scholar Google Scholar Articles by Krall, R. L Articles by Rockhold, F. Search for Related Content PubMed PubMed Citation Social Bookmarking                      What's this?

Letters

Reasons for optimism not disillusionment

Ronald L Krall¹   Frank Rockhold²

¹ Chief Medical Officer GlaxoSmithKline, UK
² Senior Vice President Biomedical Data Sciences, UK

E-mail: ronald.l.krall{at}gsk.com

Iain Chalmers' disillusionment (July 2006 JRSM¹) with GlaxoSmithKline's (GSK) commitment to clinical trial transparency is misplaced. We believe a more complete account of GSK policy and practice paints a very different picture.

Glaxo Wellcome (GW) launched a password protected clinical trial register in 1998. It provided summary protocol information and references from phase II-IV clinical trials of approved medicines. This register was not updated following the formation of GSK. However, trial transparency has been significantly enhanced through the development of a GSK policy and clinical trial register.^2,3 This work was initiated prior to the action brought against GSK by the New York State Attorney General.

The GSK clinical trial register (launched in September 2004) provides greater transparency and more information compared with the GW register. Available to anyone with Internet access, it includes not only references but also the results from all trials (phase I-IV) of marketed medicines. The scope of trials included exceeds that in recognised industry guidelines—the PhRMA Principles on the Conduct of Clinical Trials and the Communication of Clinical Trial Results.⁴ The GSK clinical trial register contains studies completed since the formation of GSK; there are currently over 2600 trials.

As for registering summary protocol information as trials begin, in 2005 we committed to posting all our patient trials on Clinicaltrials.gov.⁵ Moreover, we have recently extended our policy, to include registration of phase I studies in healthy volunteers. In this regard, we exceed the requirements of the International Committee of Medical Journal Editors.

We believe this record of transparency is unsurpassed. Other industry sponsors have made similar commitments and we are optimistic that comparable polices will be adopted by academic and governmental sponsors of clinical research.

Footnotes

Competing interests None declared.

REFERENCES

1. Chalmers I. From optimism to disillusion about commitment to transparency in the medico-industrial complex. J R Soc Med 2006;99:337 -41[Free Full Text]

2. [http://ctr.gsk.co.uk/welcome.asp] Accessed 8 August 2006

3. Krall R, Rockhold F. More on compulsory registration of clinical trials: GSK has created useful register. BMJ2005; 330:479 -80[Free Full Text]

4. [http://www.phrma.org/principles_and_guidelines/] Accessed 8 August 2006

5. [http://clinicaltrials.gov] Accessed 8 August 2006

CiteULike    Complore    Connotea    Del.icio.us    Digg    Reddit    Technorati    What's this?

This Article Full Text (PDF) Send a Quick Comment Alert me when this article is cited Alert me when Quick Comments are posted Alert me if a correction is posted Services Email this article to a friend Similar articles in this journal Similar articles in PubMed Alert me to new issues of the journal Download to citation manager Citing Articles Citing Articles via Google Scholar Google Scholar Articles by Krall, R. L Articles by Rockhold, F. Search for Related Content PubMed PubMed Citation Social Bookmarking                      What's this?