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.
Statistics from Altmetric.com
If you wish to reuse any or all of this article please use the link below which will take you to the Copyright Clearance Center’s RightsLink service. You will be able to get a quick price and instant permission to reuse the content in many different ways.
▸ 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.
Read the full text or download the PDF:
Other content recommended for you
- Implementing post-trial access plans for HIV prevention research
- Investigation of post-trial access views among study participants and stakeholders using photovoice and semistructured interviews
- ‘Ethical responsibility’ or ‘a whole can of worms’: differences in opinion on incidental finding review and disclosure in neuroimaging research from focus group discussions with participants, parents, IRB members, investigators, physicians and community members
- Phase I oncology trials: why the therapeutic misconception will not go away
- How to write a systematic review of reasons
- Should post-trial provision of beneficial experimental interventions be mandatory in developing countries?
- Challenges with participant reimbursement: experiences from a post-trial access study
- Forthcoming practical framework for ethics committees and researchers on post-trial access to the trial intervention and healthcare
- Developing ethics guidance for HIV prevention research: the HIV Prevention Trials Network approach
- Post-trial access to study medication: a Brazilian e-survey with major stakeholders in clinical research