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PA-513 Experience with AVAREF regulatory procedure to facilitate clinical trial startup in sub-Saharan Africa
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  1. Nekoye Otsyula,
  2. Sabine Pfeffer,
  3. Diogo Mato,
  4. Yves Thomas,
  5. Caroline Boulton
  1. Novartis Pharma AG, Switzerland

Abstract

Background The African Vaccine Regulatory Forum (AVAREF) is a network of African national regulatory authorities (NRAs) and ethics committees (NECs) with an objective of improving access to medicines by reducing and standardizing review and approval times for clinical trial applications, while also optimizing quality of regulatory processes across sub-Saharan Africa (SSA)¹. It utilizes joint reviews and parallel CTA submissions to NRAs, NECs and Institutional Review Boards (IRBs).

Methods Novartis piloted use of the AVAREF procedure for a Phase 2 clinical study in malaria patients involving 7 countries/13 sites in SSA.

Results A letter of intent for a scientific advice meeting was submitted to AVAREF to trigger the procedure start. The meeting occurred 2 months later with participation of experts from SSA. One NEC identified for inclusion in the procedure did not agree to participate.

The timetable was agreed by all parties, which facilitated CTA parallel submissions. However, differences in understanding of the procedure emerged. Despite scheduling of a face to face joint review meeting including all parties to discuss questions on the CTA, two NEC approvals were received prior to the joint review. Validation questions requesting sequential approvals by IRBs/ECs were also received. The procedure is currently ongoing, and the pilot will inform the path for future EC/HA submissions in SSA.

Conclusion AVAREF procedure holds promise to reduce lengthy sequential NEC and NRA approval timelines in SSA. It also provides a forum for open discussion of study-related questions and for scientific advice in SSA. Attention is warranted to further clarify the review process and expectations for NECs, in particular.

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