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. 2009 Jan-Feb;10(1):13-24.
doi: 10.1310/hct1001-13.

Access to medications and medical care after participation in HIV clinical trials: a systematic review of trial protocols and informed consent documents

Andrea L Ciaranello  1 , Rochelle P Walensky, Paul E Sax, Yuchiao Chang, Kenneth A Freedberg, Joel S Weissman
Affiliations

Access to medications and medical care after participation in HIV clinical trials: a systematic review of trial protocols and informed consent documents

Andrea L Ciaranello et al. HIV Clin Trials. 2009 Jan-Feb.

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 (> or = 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.

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Conflict of interest statement

Conflicts of interest: Paul E. Sax reports serving as a consultant for Abbott, BMS, Gilead, Glaxo-SmithKline, Merck, and Tibotec; receiving teaching honoraria from Abbott, BMS, Gilead, Merck, and Tibotec; and receiving grant support from Tibotec and Merck. Other authors have no conflicts of interest to disclose.

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