Revista de SIDA e investigación clínica

Regulatory and Ethical Approval Timelines for HIV Vaccine Studies: An Analysis of International AIDS Vaccine Initiative (IAVI) Sponsored Studies in East and Southern Africa

Abstract

Prince Bahati, Zablon Omungo, Bonnie Bender and Josea Rono

Background: There has not been a systematic analysis of factors affecting ethics and regulatory timelines of HIV Vaccine trials and epidemiologic studies in Eastern and Southern Africa. We analyzed regulatory and ethics approval timelines and associated factors for HIV vaccine clinical trials and epidemiologic studies in Kenya, Uganda, Rwanda, South Africa and Zambia using data collected from seven Clinical Research Centers (CRCs) from 2001 to 2015. Methodology: Staff responsible for regulatory issues at CRCs provided archived data on ethical and regulatory review time-frames which were then validated with the sponsor central database. A semi structured questionnaires was administered to establish qualitative information on perceived factors affecting efficiency of approval processes and potential solutions. Quantitative data analysis was conducted using Excel. Qualitative data were analyzed using an open coding to analyze and elicit general themes. Findings: Data on submission for 23 clinical trials and 51 epidemiological study protocols were analyzed. Across all seven CRCs it took on average of 178 and 108 days to obtain full authorization to commence clinical trials and epidemiological studies, respectively. These timelines are shorter than the average found in other disease fields in Africa but seem longer than approval timelines in the USA and the EU that are estimated at 15-45 days and 43-75 days, respectively. We found that countries with sequential, rather than parallel, submission procedures had longer review timelines. Clinical trial approval timelines that were longer than 200 days were associated with amendment submissions prior to initial approval and with investigational products that required institutional biosafety committee reviews. Lengthier approval timelines were also associated with epidemiological studies with more invasive procedures. Conclusion: Strategies to further shorten timelines will need to focus on adoption of parallel approval processes; increase frequency of ethical review meetings and capacity strengthening of ethical review institutions.