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Subjects’ views of obligations to ensure post-trial access to drugs, care and information: qualitative results from the Experiences of Participants in Clinical Trials (EPIC) study
  1. N Sofaer1,
  2. C Thiessen2,
  3. S D Goold3,
  4. J Ballou4,
  5. K A Getz5,
  6. G Koski6,
  7. R A Krueger7,
  8. J S Weissman8
  1. 1
    Formery Program in Ethics and Health, Harvard University, Boston, Massachusetts, USA
  2. 2
    Harvard University PhD Program in Health Policy; Institute of Health Policy, Massachusetts General Hospital, Boston, Massachusetts, USA
  3. 3
    University of Michigan Medical School Bioethics Program; Department of Internal Medicine, Ann Arbor, Michigan, USA
  4. 4
    Mathematica Policy Research, Inc, Princeton, New Jersey, USA
  5. 5
    Tufts Center for the Study of Drug Development, Tufts University, Boston, Massachusetts, USA and The Center for Information and Study on Clinical Research Participation, Dedham, Massachusetts, USA
  6. 6
    Institute for Health Policy and Department of Anesthesia and Critical Care, Massachusetts General Hospital; Harvard Medical School, Boston, Massachusetts, USA
  7. 7
    Educational Policy and Administration, University of Minnesota, Minneapolis, Minnesota, USA
  8. 8
    Harvard Medical School; Institute for Health Policy, Massachusetts General Hospital, Boston, Massachusetts, USA
  1. Dr J S Weissman, Institute for Health Policy, Massachusetts General Hospital, 50 Staniford Street, 9th Floor, Boston, MA 02114, USA; jweissman{at}partners.org

Abstract

Objectives: To report the attitudes and opinions of subjects in US clinical trials about whether or not, and why, they should receive post-trial access (PTA) to the trial drug, care and information.

Design: Focus groups, short self-administered questionnaires.

Setting: Boston, Dallas, Detroit, Oklahoma City.

Participants: Current and recent subjects in clinical trials, primarily for chronic diseases.

Results: 93 individuals participated in 10 focus groups. Many thought researchers, sponsors, health insurers and others share obligations to facilitate PTA to the trial drug, if it benefited the subject, or to a therapeutic equivalent. Some thought PTA obligations include providing transition care (referrals to non-trial physicians or other trials, limited follow-up, short-term drug supply) or care for long-term adverse events. Others held, in contrast, that there are no PTA obligations regarding drugs or care. However, there was agreement that former subjects should receive information (drug name, dosage received, market approval date, long-term adverse effects, trial results). Participants frequently appealed to health need, cost, relationships, reciprocity, free choice and sponsor self-interest to support their views. Many of their reasons overlapped with those commonly discussed by bioethicists.

Conclusion: Many participants in US trials for chronic conditions thought there are obligations to facilitate PTA to the trial drug at a “fair” price; these views were less demanding than those of non-US subjects in other studies. However, our participants’ views about informational obligations were broader than those of other subjects and many bioethicists. Our results suggest that the PTA debate should expand beyond the trial drug and aggregate results.

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Footnotes

  • ▸ Additional appendix data are published online only at http://jme.bmj.com/content/vol35/issue3

  • Funding: This study was funded by the National Institute of Nursing Research. The funders did not have any role in the design and conduct of the study; collection, management, analysis, and interpretation of the data; and preparation, review, or approval of the manuscript.

  • Competing interests: None.

  • Ethics approval: The following institutional review boards reviewed the EPIC Study: Partners Human Research Committee, Harvard School of Medicine Human Subjects Committee, IRBMED at the University of Michigan Medical School, Public/Private Ventures IRB, New England IRB, and National Institutes of Health IRB.

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