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.
PERMISSIONSThe Corresponding Author has the right to grant on behalf of all authors and does grant on behalf of all authors, an exclusive licence on a worldwide basis to the BMJ Publishing Group Ltd and its Licensees to permit this article (if accepted) to be published in JME editions and any other BMJPGL publications to exploit all subsidiary rights, as set out in its licence (http://jme.bmjjournals.com/ifora/licence.dtl) NIH Public Access 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-Ninety-three individuals participated in ten 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, shortterm 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.