Towards the development of a global CORE protocol for
evaluation of treatments for MPX
Leveraging the Congolese Experience
10 – 11 July 2022
10 – 11 July 2022 --- Hybrid meeting in the Democratic Republic of the Congo
Day 1: Time: 13h00 to 18h00 (Kinshasa time) or 14h00 to 19h00 (CET time)
Day 2: Time: 13h00 to 15h30 (Kinshasa time) or 14h00 to 16h30 (CET time)
The INRB and the ANRS |Emerging Infectious Diseases/INSERM in collaboration with WHO organized a consultation Towards the development of aglobal CORE protocol for evaluation of treatments for MPX on 10-11 July
2022.
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 Democratic Republic of the Congo.
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 aimed 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.
DOWNLOAD CORE PROTOCOL - A randomized, placebo-controlled, double-blinded
trial of the safety and efficacy of treatments for
patients with monkeypox virus disease
The objectives of the meeting were:
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.
