Seung Yeon Song1, Deborah Chee2, EunYoung Kim1,3. 1. 1 Department of Health, Social and Clinical Pharmacy, College of Pharmacy, Chung-Ang University, Seoul, Korea. 2. 2 Korea National Enterprise for Clinical Trials (KoNECT), Seoul, Korea. 3. 3 Division of Licensing of Medicines and Regulatory Science, The Graduate School Pharmaceutical Management, Chung-Ang University, Seoul, Korea.
Abstract
BACKGROUND: With the recent publication of the International Conference on Harmonisation E17 guideline and major reforms in China underway, the platform for clinical trial conduct is expected to change. This study aims to assess the strategic inclusion of regions in clinical trials and its change in trends over the past decade. METHODS: The ClinicalTrials.gov registry was searched for clinical trials registered by the top 10 pharmaceutical companies between 1 January 2008 and 31 December 2017. Extracted data included phase, disease type, intervention, study start year, and region. Trial type was classified as either a local study or a multiregional clinical trial as per the International Conference on Harmonisation E17 guideline. RESULTS: Of 2488 phase I, 1855 phase II, and 1999 phase III trials included, the majority of phase I trials were local studies (76.8%), while the majority of phase II (66.0%) and phase III (72.2%) trials were multiregional clinical trials. The proportion of multiregional clinical trials showed an increasing trend for all phases ( p < 0.01). Although North America and Europe remained the main locations, increasing trends of inclusion of other regions, such as East Asia, were noted. CONCLUSION: Globalization of drug development is evident with the increasing trend of multiregional clinical trial. Regulatory authorities as well as the pharmaceutical industry should prepare for the evolving setting of clinical research and problems that can arise from these changes.
BACKGROUND: With the recent publication of the International Conference on Harmonisation E17 guideline and major reforms in China underway, the platform for clinical trial conduct is expected to change. This study aims to assess the strategic inclusion of regions in clinical trials and its change in trends over the past decade. METHODS: The ClinicalTrials.gov registry was searched for clinical trials registered by the top 10 pharmaceutical companies between 1 January 2008 and 31 December 2017. Extracted data included phase, disease type, intervention, study start year, and region. Trial type was classified as either a local study or a multiregional clinical trial as per the International Conference on Harmonisation E17 guideline. RESULTS: Of 2488 phase I, 1855 phase II, and 1999 phase III trials included, the majority of phase I trials were local studies (76.8%), while the majority of phase II (66.0%) and phase III (72.2%) trials were multiregional clinical trials. The proportion of multiregional clinical trials showed an increasing trend for all phases ( p < 0.01). Although North America and Europe remained the main locations, increasing trends of inclusion of other regions, such as East Asia, were noted. CONCLUSION: Globalization of drug development is evident with the increasing trend of multiregional clinical trial. Regulatory authorities as well as the pharmaceutical industry should prepare for the evolving setting of clinical research and problems that can arise from these changes.
Keywords:
Multiregional clinical trial; clinical trial; region
Authors: Kevin Wu; Eric Wu; Michael DAndrea; Nandini Chitale; Melody Lim; Marek Dabrowski; Klaudia Kantor; Hanoor Rangi; Ruishan Liu; Marius Garmhausen; Navdeep Pal; Chris Harbron; Shemra Rizzo; Ryan Copping; James Zou Journal: AAPS J Date: 2022-04-21 Impact factor: 4.009