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Considering Usual Medical Care in Clinical Trial Design

  • Liza Dawson mail,

    dawsonl@niaid.nih.gov

    Affiliation: Division of AIDS, National Institute of Allergy and Infectious Diseases, National Institutes of Health, Bethesda, Maryland, United States of America

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  • Deborah A. Zarin,

    Affiliation: ClinicalTrials.gov, National Library of Medicine, National Institutes of Health, Bethesda, Maryland, United States of America

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  • Ezekiel J. Emanuel,

    Affiliation: Department of Clinical Bioethics, Warren G. Magnusen Clinical Center, National Institutes of Health, Bethesda, Maryland, United States of America

    X
  • Lawrence M. Friedman,

    Affiliation: Independent Consultant, Rockville, Maryland, United States of America

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  • Bimal Chaudhari,

    Affiliation: Department of Pediatrics, Washington University School of Medicine, St. Louis, Missouri, United States of America

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  • Steven N. Goodman

    Affiliation: Department of Oncology, Johns Hopkins University School of Medicine, Baltimore, Maryland, United States of America

    X
  • Published: September 29, 2009
  • DOI: 10.1371/journal.pmed.1000111

About the Authors

Liza Dawson
Division of AIDS, National Institute of Allergy and Infectious Diseases, National Institutes of Health, Bethesda, Maryland, United States of America
Deborah A. Zarin
ClinicalTrials.gov, National Library of Medicine, National Institutes of Health, Bethesda, Maryland, United States of America
Ezekiel J. Emanuel
Department of Clinical Bioethics, Warren G. Magnusen Clinical Center, National Institutes of Health, Bethesda, Maryland, United States of America
Lawrence M. Friedman
Independent Consultant, Rockville, Maryland, United States of America
Bimal Chaudhari
Department of Pediatrics, Washington University School of Medicine, St. Louis, Missouri, United States of America
Steven N. Goodman
Department of Oncology, Johns Hopkins University School of Medicine, Baltimore, Maryland, United States of America

Corresponding Author

Email: dawsonl@niaid.nih.gov

Competing Interests

DZ is employed by the National Institutes of Health as a senior scientist, and the Director, ClinicalTrials.gov. She has no other relevant interests. LMF is now retired but was an employee of the NIH institute (the National Heart, Lung, and Blood Institute) that funded the ARDS Network, and was a senior-level NHLBI employee at the time of the controversy regarding the ARDSNet study that stimulated the conference discussed in the paper.

Author Contributions

ICMJE criteria for authorship read and met: LD DZ EJE LMF BC SNG. Wrote the first draft of the paper: LD. Contributed to the writing of the paper and the conceptual framework: LD DZ EJE LMF BC SNG. Analysis of case studies: BC. Contributed to conceptual framework: LD DZ EJE LMF BC SNG.