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Response to Dr. Krleza-Jeric

Posted by plosmedicine on 30 Mar 2009 at 23:49 GMT

Author: Frank Rockhold, PhD
Position: Senior Vice President
Institution: GlaxoSmithKline R&D
Additional Authors: Ronald Krall, MD, SVP and Chief Medical Officer
Submitted Date: December 23, 2005
Published Date: January 5, 2006
This comment was originally posted as a “Reader Response” on the publication date indicated above. All Reader Responses are now available as comments.

We read with great interest the recent review article in PLoS Medicine on clinical trial registration. GlaxoSmithKline is committed to enhancing the transparency of clinical trial information through protocol registration and the registration of the results of clinical trials.

We are therefore disappointed that the article suggests the pharmaceutical industry is reluctant to embrace greater transparency and disclosure. In September 2004 GSK became the first company, and we believe the first trial sponsor, to establish a publicly available internet-based clinical trial register to provide results from all GSK-sponsored clinical trials of marketed medicines. The register currently has over 2000 records and there are now similar registers and databases across industry. Indeed, as you note in your article, in January 2005 industry made a commitment to disclose clinical trial information (summary protocol and results) on clinical trial registers and databases which has been followed by a further position paper in September 2005. This latter position paper confirms industry's support for the agreement reached at the WHO Technical Consultation Meeting on Clinical Trials Registration Standards held on 25-27 April 2005. Moreover, industry has launched a Clinical Trial Portal to enable and facilitate access to clinical trial information.

The article focuses on the registration of clinical trial protocol information and we agree that this is important to alert physicians and patients of the opportunity to participate and to serve as a public record to ensure results are publicly disclosed. However, we are surprised that you make little mention of results registration. It is registration of results (not summary protocol information) that helps to ensure that researchers, physicians and others are aware of all the relevant information from clinical trials of medical interventions and can review the literature appropriately it is this which can impact patient care.

With regard to registration of summary protocol information, we can appreciate that the discussion and debate around the WHO minimal data set and the five data elements may have given the impression that industry is not embracing the concept of transparency and disclosure. However industry has made the point about competitively sensitive information for a very good reason and that is that disclosure of one or more of these five data elements early in the process of drug development may undermine medicine development. The discovery and development of medicines is fundamental in the social contract that the pharmaceutical industry has with society and undermining this is not in the interests of patients and society in general. Nonetheless, it is important to recognise that delay of one or more data elements will be by exception only. Industry will, whenever possible, disclose all 20 data elements in the WHO minimal data set. GSK, for example will only delay registration of one data element for some early phase (exploratory) trials and that has to be approved by our Chief Medical Officer, Dr. Krall. All GSK-sponsored trials that, to use the ICJME terminology, are 'clinically directive' will be registered with all 20 data elements. The GSK approach is fully aligned with the ICMJE policy. Therefore, we do not believe that an escrow mechanism or other elaborate mechanism is required or justified for such a small number of data elements in such a small number of trials. We would however be concerned that if in practice the frequency of delays is high. Therefore a pragmatic way forward would be to review practice after 12-18 months to assess the extent of the issue (if any).

We hope these comments are helpful and constructive. We would be happy to discuss our views with the author in greater detail at any time if that would be helpful.

Frank W. Rockhold and Ronald L Krall

Competing interests declared: Employees of GlaxoSmithKline