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Antonia Agustí
Antonia AgustÃ
Spain
Publications
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Research Article
Serious Adverse Events Reporting and Follow-Up Requirements in the European and Developing Countries Clinical Trials Partnership-Funded Clinical Trials: Current Practice
Author(s): Jean Marie Vianney Habarugira, Antonia Agustà and Michael MakangaJean Marie Vianney Habarugira, Antonia Agustí and Michael Makanga
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 .. View More»
DOI: 10.4172/2329-6887.1000148