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


METHODS
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.
Ciaranello
Andrea L
AL
Division of Infectious Disease, Massachusetts General Hospital, Boston, MA 02114, USA. aciaranello@partners.org
Walensky
Rochelle P
RP
Sax
Paul E
PE
Chang
Yuchiao
Y
Freedberg
Kenneth A
KA
Weissman
Joel S
JS
D000293:Adolescent; D000328:Adult; D044966:Anti-Retroviral Agents / Q000600:supply & distribution* / Q000627:therapeutic use; D002648:Child; D002985:Clinical Protocols; D017326:Clinical Trials, Phase III as Topic / Q000706:statistics & numerical data; D017327:Clinical Trials, Phase IV as Topic / Q000706:statistics & numerical data; D032962:Consent Forms; D019049:Developed Countries; D003906:Developing Countries; D005260:Female; D015658:HIV Infections / Q000188:drug therapy*; D006297:Health Services Accessibility / Q000706:statistics & numerical data*; D006801:Humans; D008297:Male; D014481:United States
D044966:Anti-Retroviral Agents