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(Circulation. 2005;111:e393.)
© 2005 American Heart Association, Inc.

Correspondence

Letter Regarding Article by Armstrong et al, "Lessons Learned From a Clinical Trial"

Christopher C. Nessel, MD

The Medicines Company, Parsippany, NJ, christopher.nessel{at}themedco.com

To the Editor:

I read with interest the article by Armstrong and colleagues on the SYMPHONY experience.¹ As the medical director for the SYNERGY² trial, I noted with appreciation the acknowledgement of industry investigators and their contribution, "to the design, analysis, and interpretation of clinical research...."

Importantly, the statements concerning academic–industrial partnerships were seminal. Encouraging the formation and use of a publications committee is laudable. The SYNERGY trial could be called a paradigm in this regard. I was privileged to co-chair this committee with Dr Kenneth Mahaffey of Duke University. This structure yielded accomplishments that could not have been achieved singly.

I must disagree, however, with the exhortations to perform data analysis and interpretation independent of the sponsor. Certainly, the integrity of data analysis does not abide exclusively in the academe. I contend that the sole means of approaching objectivity is to engage investigators from the clinical as well as the industrial arena. This bicameral approach was eminently successful in the analysis of the SYNERGY dataset.

	References

Top References References

 

1. Armstrong PW, Newby LK, Granger CB, Lee KL, Simes RJ, Van de Werf F, White HD, Califf RM; Virtual Coordinating Centre for Global Collaborative Cardiovascular Research (VIGOUR) Group. Lessons learned from a clinical trial. Circulation. 2004; 110: 3610–3614.[Free Full Text]
   
2. Ferguson JJ, Califf RM, Antman EM, Cohen M, Grines CL, Goodman S, Kereiakes DJ, Langer A, Mahaffey KW, Nessel CC, Armstrong PW, Avezum A, Aylward P, Becker RC, Biasucci L, Borzak S, Col J, Frey MJ, Fry E, Gulba DC, Guneri S, Gurfinkel E, Harrington R, Hochman JS, Kleiman NS, Leon MB, Lopez-Sendon JL, Pepine CJ, Ruzyllo W, Steinhubl SR, Teirstein PS, Toro-Figueroa L, White H; SYNERGY Investigators. Enoxaparin vs. unfractionated heparin in high-risk patients with non-ST-segment elevation acute coronary syndromes managed with an intended early invasive strategy: primary results of the SYNERGY randomized trial. JAMA. 2004; 292: 45–54.[Abstract/Free Full Text]
   

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Paul W. Armstrong, MD

University of Alberta, Edmonton, Alberta, Canada

L. Kristin Newby, MD, MHS; Christopher B. Granger, MD; Kerry L. Lee, PhD; Robert M. Califf, MD

Duke Clinical Research Institute, Durham, NC

R. John Simes, MD

National Health & Medical Research Council, Sydney, Australia

Frans Van de Werf, MD, PhD

University Hospital Gasthuisberg, Leuven, Belgium

Harvey D. White, DSc

Auckland City Hospital, Auckland, New Zealand

Response

We appreciate the comments of Christopher Nessel, and we are glad that as a clinician scientist in industry, he concurs with the synergistic potential of academic–industrial partnerships we have described.¹

Our "exhortation" to perform data analysis and interpretation independent of the sponsor, is, we believe, a fundamental tenant of this partnership. Hence, in our view, each partner or shareholder should possess the final data set emerging from the research, and performing replicate analysis and confirmation of the results provides eloquent and transparent testimony as to the study’s integrity.

This, and other issues associated with previous protocol publication with access from the public domain can, in our view, only enhance public and professional confidence in the results of collaborative clinical investigation sponsored by industry, which shall surely remain an important element in future scientific advances.²

	References

Top References References

 

1. Armstrong PW, Newby LK, Granger CB, Lee KL, Simes RJ, Van de Werf F, White HD, Califf RM; Virtual Coordinating Centre for Global Collaborative Cardiovascular Research (VIGOUR) Group. Lessons learned from a clinical trial. Circulation. 2004; 110: 3610–3614.[Free Full Text]
   
2. DeAngelis CD, Drazen JM, Frizelle FA, Haug C, Hoey J, Horton R, Kotzin S, Laine C, Marusic A, Overbeke AJ, Schroeder TV, Sox HC, Van Der Weyden MB; International Committee of Medical Journal Editors. Clinical trial registration: a statement from the International Committee of Medical Journal Editors. JAMA. 2004; 292: 1363–1364.[Free Full Text]
   

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