To the Editor: The Abbasi [1] editorial and letters in a recent
issue of the BMJ [2,3,4,5] illustrate the considerable interest in the
registration of clinical trials. 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 endpoints 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 enrollment,
as called for by the ICMJE [6]. In the meantime, we have begun 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 NLM
number in our results register and scientific publications.
Finally, GSK is committed to assuring that our results Register and
our posting of trials initiating enrollment 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.
Ronald Krall, MD
Senior Vice President, Worldwide Development
Frank Rockhold, PhD
Senior Vice President, Biomedical Data Sciences
GlaxoSmithKline,
Upper Merion, Pa
1. Abbasi K. Compulsory registration of clinical trials. BMJ 2004;
329: 637-8 (18 September)
2. Stewart L, Vale C, Darbyshire J. Compulsory registration of
clinical trials: Publicly funded national register would be best in the
United Kingdom. BMJ 2004; 329: 1043-b
3. Singer EA, Druml C. Compulsory registration of clinical trials:
Maybe European research should be protected. BMJ 2004; 329: 1044
4. Jay P, Wallace M. Compulsory registration of clinical trials:
Under-reporting is not an option. BMJ 2004; 329 1044-a
5. Wager E. Pressures are growing to publish clinical trials BMJ
2004; 329: 1044-b
6. Clinical Trial Registration: a statement from the International
Committee of Medical Journal Editors. JAMA. 2004;292:1363.
Rapid Response:
Clinical Trials Registers
To the Editor: The Abbasi [1] editorial and letters in a recent
issue of the BMJ [2,3,4,5] illustrate the considerable interest in the
registration of clinical trials. 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 endpoints 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 enrollment,
as called for by the ICMJE [6]. In the meantime, we have begun 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 NLM
number in our results register and scientific publications.
Finally, GSK is committed to assuring that our results Register and
our posting of trials initiating enrollment 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.
Ronald Krall, MD
Senior Vice President, Worldwide Development
Frank Rockhold, PhD
Senior Vice President, Biomedical Data Sciences
GlaxoSmithKline,
Upper Merion, Pa
1. Abbasi K. Compulsory registration of clinical trials. BMJ 2004;
329: 637-8 (18 September)
2. Stewart L, Vale C, Darbyshire J. Compulsory registration of
clinical trials: Publicly funded national register would be best in the
United Kingdom. BMJ 2004; 329: 1043-b
3. Singer EA, Druml C. Compulsory registration of clinical trials:
Maybe European research should be protected. BMJ 2004; 329: 1044
4. Jay P, Wallace M. Compulsory registration of clinical trials:
Under-reporting is not an option. BMJ 2004; 329 1044-a
5. Wager E. Pressures are growing to publish clinical trials BMJ
2004; 329: 1044-b
6. Clinical Trial Registration: a statement from the International
Committee of Medical Journal Editors. JAMA. 2004;292:1363.
Competing interests:
Employee of GlaxoSmithKline
Competing interests: No competing interests