Towards the development of a global CORE protocol for evaluation of treatments for hMPXV

08 July 2022
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10 – 11 July 2022 - Hybrid meeting in DRC

The INRB and the ANRS | Emerging Infectious Diseases/INSERM in collaboration with WHO are organizing a consultation "Towards the development of a global CORE protocol for evaluation of treatments for hMPXV" on 10-11 July 2022.

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As part of a prior initiative the INRB, the NIAID/NIH and other partners have developed a protocol for a randomized evaluation of treatments for human monkeypox (the PALM 007 RCT protocol) in the DRC.  

Building on the PALM 007 RCT protocol, the PALM 007 team experience and, on the experience from all researchers from countries with cases, this meeting will aim to outline the design of a new global CORE RCT protocol to facilitate integration of clinical research in all countries reporting cases and promote global collaboration.

The objectives of the meeting are the following:

  • To share current proposals on the design, endpoints definition, and statistical considerations for the global CORE protocol emerging from the discussions by various working groups including Target Product Profile, Regulatory, Clinical Management and endpoints and, Statistical Analysis groups.

  • To reach consensus on the design of the CORE protocol.

  • To outline plans for study conducted under a global Consortium approach, including governance framework, data management, and other enabling functions.

The meeting is open to all researchers interested in this topic: