Back

Biography

            Born and raised in Burundi, Jean Marie Vianney moved to Russia in 2000 for his graduate and post-graduate studies. In 2006, he obtained a Master of Science in Pharmacy at the Volgograd State Medical University, in Volgograd, Russia. He then moved to The Netherlands where he obtained a Bachelor degree in Business Administration at the NHL University in Leeuwarden before continuing his life sciences research education at the Utrecht University, in a Drug Innovation Masters programme focussing on Drug Discovery, Drug Development and Regulatory Affairs. During the Drug Innovation training, he carried out research projects at the KNCV Tuberculosis Foundation in The Netherlands, the Dutch Medicines Evaluation Board and EDCTP. Since December 2010, he has been working for EDCTP as a Project Officer, managing several EDCTP-funded grants and calls for proposals. As part of his continuing professional development and academic interest, in July 2014 Jean Marie Vianney successfully defended a Master’s Thesis within the European Programme in Pharmacovigilance and Pharmacoepidemiology (Eu2P).

Abstract

Background: This study aimed to assess the current pharmacovigilance practice and compliance with the International Committee for Harmonization Good Clinical Practice (ICH-GCP) requirements within a range of clinical trials funded by the European and Developing Countries Clinical Trials Partnership (EDCTP). Methods: A combination of a retrospective desk review of projects documentation as of June 2014 and a prospective survey among EDCTP-funded clinical trials investigators were used. Results: The overall survey response rate was 64.3%. Among the 54 trial investigators who responded to the survey, 64% are sponsored by academic institutions, 25% by public research institutions, and 6% by Product Development Partnerships (PDPs). 77% of the Sponsors are based in Europe, 17% in Africa and 6% are global-based institutions. 75% of the respondents confirmed occurrence and reporting of Serious Adverse Events (SAEs) in their trials. The primary reference document for SAEs reporting and follow up reported as % of clinical trials are clinical trial protocols (81.5%), SOPs for handling SAEs (50%) and investigator brochure (11%). The average SAE reporting time by 81% of respondents is within 24 hours, 11% within 48 hours, 4% within 7 days and 2% between 7 and 15 days. Majority (79.6%) of investigators report SAEs directly to the their trial Sponsors, 62.3% to National Ethics Committees (NECs) and Institutional Review Boards (IRBs), 33.3% to the national regulatory authorities (NRAs), 22.2% to the safety monitors, and 3.7% to the Contract Research Organisations (CROs). Combinations of these recipients were reported by several respondents. Among the 41 respondents who reported SAEs occurrence in their trial, only 22 confirmed that they are required to report to their NECs and IRBs. 85% of respondents send SAEs reports by e-mail, 27.8% by Fax mail, 11.1% by telephone and 9.3% as printed hard copies. Conclusion: A majority of respondents (75%) confirmed that SAEs have occurred in their trials; in this group, 45% of respondents did not confirm the requirement of reporting SAEs to local oversight bodies. It is important that both NECs and NRAs in all countries where clinical trials are conducted clearly make available their reporting requirements to the investigators to ensure adequate compliance with local reporting requirements. Further studies are necessary to better understand the magnitude of this problem and to strengthen capacity of local trial oversight by NECs and NRAs.

Speaker Presentations