Regulatory workshop on standardisation of clinical procedures, endpoints and data robustness of human challenge studies: a stakeholder meeting report

Author(s):
Meln, I.; Cnossen, V.; Corti, N.; Andeweg, A.; Baay, M.; Chiu, C.; Coia, J.; Cornely, O.; Cox, R.J.; Dasyam, D.; Keersmaecker, S.C.J.D.; Deming, M.; Waldock, J.; Engelhardt, O.G.; Guo, M.M.; Saflo, O.H.A.; Hensen, A.; Jeeninga, R.; Kolstoe, S.; Krut, O.; Kuijper, E.J.; Leal, L.; Mazur, N.; Mohn, K.G.I.; Morel, S.; Osterhaus, A.; Moreira, A.P.; Smits, W.K. (0000-0002-7409-2847); Sridhar, S.; Toomey, D.; Gerven, J. van; Vehreschild, M.J.G.T.; Yarzabal, J.P.; Zimmer-Harwood, P.; Neels, P.; Olesen, O.F.; Roestenberg, M. (0000-0002-5052-2830); Kamerling, I.M.C.
Published
2025
Publication type
Article / Letter to editor

Abstract

influenza, respiratory syncytial virus (RSV), and toxigenic Clostridioides difficile for controlled human infection model studies (CHIMs). A regulatory workshop held on March 20, 2024, addressed the standardisation of clinical procedures, ethical considerations, endpoints, and data integrity, highlighting the ongoing initiatives related to these CHIMs. Key discussions focused on refining trial protocols to balance statistical power with participant burden, overseen by a data safety monitoring board. The meeting emphasised the importance of harmonizing CHIM protocols to ensure robust, reproducible, and transparent research. Mandatory trial registration and adherence to the Findable, Accessible, Interoperable, and Reusable (FAIR) data principles were recommended to enhance data reuse and scientific value. This report consolidates efforts to standardise CHIM protocols, essential for accelerating therapeutic innovations and advancing global health research.

Influenza virusRespiratory syncytial virusClostridioides difficileControlled human infection studiesHuman challenge trialsCHIM
Date issued
2025-01-17
Language
English
Publisher
ACADEMIC PRESS LTD- ELSEVIER SCIENCE LTD
Is part of
Biologicals
hdl
1887/4293789
doi
10.1016/j.biologicals.2025.101818
URL
https://www.sciencedirect.com/science/article/pii/S1045105625000090?via%3Dihub