The American Journal of Medicine
Volume 123, Issue 6 , Pages 481-483 , June 2010

Public Sensationalism and Clinical Trials: How to Address the Challenges of Science?

  • E. Magnus Ohman, MD

      Affiliations

    • Duke Clinical Research Institute, Duke University Medical Center, Durham, NC
    • ,
  • Matthew T. Roe, MD, MHS

      Affiliations

    • Duke Clinical Research Institute, Duke University Medical Center, Durham, NC
    • ,
  • Paul W. Armstrong, MD

      Affiliations

    • University of Alberta, Edmonton, Alberta, Canada
    • ,
  • Keith A. Fox, MB, ChB

      Affiliations

    • The Royal Infirmary of Edinburgh, Edinburgh, United Kingdom
    • ,
  • Dorairaj Prabhakaran, MD

      Affiliations

    • Center for Chronic Disease Control, New Delhi, India
    • ,
  • Harvey D. White, DSc

      Affiliations

    • Green Lane Cardiovascular Services, Auckland City Hospital, Auckland, New Zealand

References 

  1. DAMOCLES Study Group, NHS Health Technology Assessment Programme. A proposed charter for clinical trial data monitoring committees: helping them to do their job well. Lancet. 2005;365:711–722
  2. Califf RM, Harrington RA, Blazing MA. Premature release of data from clinical trials of ezetimibe. N Engl J Med. 2009;361:712–717
  3. Wiviott SD, Braunwald E, McCabe CH, et al. TRITON-TIMI 38 Investigators Prasugrel versus clopidogrel in patients with acute coronary syndromes. N Engl J Med. 2007;357:2001–2015
  4. Available at: www.fda.gov/downloads/AdvisoryCommittees/CommitteesMeetingMaterials/Drugs/CardiovascularandRenalDrugsAdvisoryCommittee/ucm129219.pdf. Accessed March 2010.
  5. Serebruany VL. Platelet inhibition with prasugrel and increased cancer risks: potential causes and implications. Am J Med. 2009;122:407–408
  6. Peppercorn J, Buss WG, Fost N, Godley PA. The dilemma of data-safety monitoring: provision of significant new data to research participants. Lancet. 2008;371:527–529

 Funding: None.

 Conflict of Interest: EMO: Research support/grants: Bristol-Myers Squibb, CV Therapeutics, Daiichi Sankyo, Datascope, Eli Lilly & Company, Sanofi-Aventis, Schering-Plough, The Medicines Company; Consulting fees: Abiomed, AstraZeneca, CV Therapeutics, Datascope, Gilead Sciences, Liposcience, Northpoint Domain, Pozen, Inc, Response Biomedical, The Medicines Company, WebMD.MTR: Research support/grants: Bristol-Myers Squibb, Eli Lilly & Company, Portola Pharmaceutical, Sanofi-Aventis, Schering-Plough; Consulting fees: Adolor Corporation, AstraZeneca, Bristol-Myers Squibb, Daiichi Sankyo, Eli Lilly & Company, Medtronic, Inc, Novartis Pharmaceutical Company, Sanofi-Aventis, Schering-Plough.PWA: Research support/grants: Boehringer Ingelheim (Canada), Ltd, Sanofi-Aventis Canada, Eli Lilly & Company, Schering Plough Research Institute, Scios Inc/Ortho-Biotech, GlaxoSmithKline, Portolo Pharmaceutical, Merck & Company, Uppsala Clinical Research Center and AstraZeneca; Consulting fees: Sanofi-Aventis, Bristol-Myers Squibb Canada, Bristol-Myers Squibb/Pfizer, Merck Frosst Canada, Ltd, Merck Frosst-Schering, Ischemix LLC, Abbott Laboratories, F. Hoffman-La Roche, Ltd, Regado Biosciences.KAF: Research supports/grants: Sanofi-Aventis, Bristol-Myers Squibb, GlaxoSmithKline, Eli Lilly & Company, Bayer; Honoraria: Sanofi-Aventis, GlaxoSmithKline.DP: Research support/grants: Duke Clinical Research Institute, Eli Lilly & Company, Merck, Sharpe & Dohme, Unilever.HDW: Research grants: Sanofi-Aventis, Eli Lilly & Company, The Medicines Company, Pfizer, Roche, Johnson & Johnson, Schering-Plough, Merck Sharpe & Dohme, AstraZeneca, GlaxoSmithKline, Daiichi Sankyo, Bristol-Myers Squibb; Consulting fees: Regado Biosciences.

 Authorship: All authors had access to the data and played a role in writing this manuscript.

PII: S0002-9343(09)01150-4

doi: 10.1016/j.amjmed.2009.12.012

The American Journal of Medicine
Volume 123, Issue 6 , Pages 481-483 , June 2010

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