Planning for posttrial access to antiretroviral treatment for research participants in developing countries.
Despite recognition of the importance of posttrial access to antiretroviral therapy (ART), the implementation process has not been studied. We examined whether the National Institutes of Health (NIH) guidance document was being implemented in NIH-funded ART trials conducted in developing countries between July 2005 and June 2007. All of the 18 studies we identified had posttrial access plans for trial participants. More than 70% had specific mechanisms for posttrial access, but none guaranteed long-term sponsor funding after the trials. The plans reflected variation in local contexts and the uncertainty of predicting local conditions in the long term. The strength of the NIH guidance document may be that it encourages investigators to formulate plans in advance and to work with other stakeholders to provide access to ART.
Shah
Seema
S
Department of Bioethics, Clinical Center, and the Henry Jackson Foundation Liaison Office, Division of AIDS, National Institutes of Health, Bethesda, MD, USA. shahse@mail.nih.gov
Elmer
Stacey
S
Grady
Christine
C
D000328:Adult; D000349:Africa; D044966:Anti-Retroviral Agents / Q000191:economics / Q000627:therapeutic use*; D001208:Asia; D002648:Child; D002675:Child, Preschool; D002986:Clinical Trials as Topic / Q000592:standards*; D003266:Continuity of Patient Care / Q000191:economics / Q000592:standards*; D003365:Costs and Cost Analysis; D003906:Developing Countries; D019983:Guideline Adherence / Q000191:economics; D017408:Guidelines as Topic; D015658:HIV Infections / Q000188:drug therapy*; D006205:Haiti; D006297:Health Services Accessibility / Q000191:economics / Q000592:standards*; D006801:Humans; D009316:National Institutes of Health (U.S.) / Q000592:standards; D035842:Research Subjects; D013020:South America; D014481:United States; D055815:Young Adult
D044966:Anti-Retroviral Agents