Abstract
The ICH E17 guidelines (2014–2017) on Multiregional Clinical Trials (MRCT) was a joint effort by the regulators and industry to facilitate simultaneous global drug development and registration through taking a strategic approach for clinical trials. In other words, the objective was to reduce the time it takes to bringing medications to patients around the world through minimizing unnecessary duplication of local or regional studies, which may add the regulatory burden to cost and time of bringing new therapies to patients. Under the auspices of ICH, training materials were created and provided to various stakeholders. Despite the successful promotion of the benefits of ICH E17 MRCT guidelines across the different regions, the uptake of some concepts (e.g., pooling strategy) in the ICH E17 guidelines has been slow. This paper describes various factors which could affect the conduct of MRCT at a global level, including ambiguity in definition of “region” (in MRCT), new regulatory requirements to enroll a diverse patient population, the use of decentralized clinical trials, use of data sources other than randomized clinical trials (e.g., use of Real Word Data), and the impact of the COVID-19 pandemic on the conduct of MRCT.
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All authors (except JW) were members of the expert working group for ICH E17 guideline published in 2017. The views expressed in this article are those of the authors and do not necessarily reflect the official views of the Pharmaceuticals and Medical Devices Agency, National Medical Products Administration or those of companies that employ them.
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RS, WW, AC work for for-profit biopharmaceutical companies. The work by AC was performed as the Senior Statistical Advisor, Office of the Commissioner, US Food and Drug Administration. JW and YU are regulators who work for their respective regulatory agencies.
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Aloka Chakravarty—This work was performed as the Senior Statistical Advisor, Office of the Commissioner, US Food and Drug Administration.
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Singh, R., Wang, W., Chakravarty, A. et al. Simultaneous Global Drug Development and Multiregional Clinical Trials (MRCT): 5 Years After Implementation of ICH E17 Guidelines. Ther Innov Regul Sci (2024). https://doi.org/10.1007/s43441-024-00639-0
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DOI: https://doi.org/10.1007/s43441-024-00639-0