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Journal Article
Access to Medications and Medical Care After Participation in HIV Clinical Trials: A Systematic Review of Trial Protocols and Informed Consent Documents

Access to Medications and Medical Care After Participation in HIV Clinical Trials: A Systematic Review of Trial Protocols and Informed Consent Documents

JournalHIV Clinical Trials
PublisherThomas Land Publishers Inc.
ISSN1528-4336 (Print)
SubjectLife Science, Medicine, Immunology and Infectious Disease and Microbiology and Virology
IssueVolume 10, Number 1 / Jan-Feb 2009
CategoryOriginal Article
Pages13-24
DOI10.1310/hct1001-13
Online DateFriday, April 10, 2009


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Referenced by
1 newer article

  1. Sofaer, N. (2011) Reasons Why Post-Trial Access to Trial Drugs Should, or Need not be Ensured to Research Participants: A Systematic Review. Public Health Ethics 4(2)
    [CrossRef]
Authors
Andrea L. Ciaranello1, Rochelle P. Walensky1, 2, 3, 4, Paul E. Sax3, Yuchiao Chang2, Kenneth A. Freedberg1, 2, 4, Joel S. Weissman5

1Division of Infectious Disease, Massachusetts General Hospital, Boston, Massachusetts, USA
2Division of General Medicine, Massachusetts General Hospital, Boston, Massachusetts, USA
3Division of Infectious Disease, Brigham and Women’s Hospital, Boston, Massachusetts, USA
4The Center for AIDS Research, Harvard Medical School, Boston, Massachusetts, USA
5Department of Family and Community Medicine, University of Massachusetts Medical School, Worcester, Massachusetts, USA

Abstract

Background: Expectations regarding receipt of medications and medical care after clinical trials conclude may inform decisions about trial participation. We describe the frequency with which these posttrial services are described in the protocols and informed consent forms (ICFs) of antiretroviral drug (ARV) trials. Method: We systematically reviewed protocols and ICFs from Phase 3 and 4 antiretroviral trials in adults (⩾12 years) from 1987 to 2006. Pharmaceutical industry-sponsored trials were selected from US Food and Drug Administration (FDA) documentation and Clinicaltrials.gov. Trials administered by the AIDS Clinical Trials Group (ACTG) were selected from the ACTG online registry. ACTG- and industry-provided protocols and ICFs were reviewed in full. The primary outcome was any mention of posttrial services, defined as any text regarding posttrial medications or medical care. Results: Complete trial documents were available for 31 (48%) of 65 trials meeting inclusion criteria. Documents from 14 trials (45%) mentioned any posttrial service: 12 (39%) mentioned medications, and 5 (16%) mentioned medical care. Payment for trial participation (74%) and for care for trial-related injury (94%) were mentioned more often than were posttrial services. Conclusions: Posttrial medications or medical care was mentioned in the trial documents of <50% of reviewed antiretroviral trials. Improved efforts are needed to clearly describe posttrial services in clinical trial protocols and ICFs.

Keywords
clinical trials, HIV, posttrial services, trial protocols

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