Multi-Regional Clinical Trials and the ICH E17 (ADDED FEE)

• Activity Number: 214061 - Multi-Regional Clinical Trials and the ICH E17 (ADDED FEE)
• Type: Professional Development
• Date/Time: Monday, July 31, 2017 : 8:00 AM to 12:00 PM
• Sponsor: ASA
• Author(s): William Wang* and Aloka Chakravarty* and Lisa LaVange* and Bruce Binkowitz*
• Companies: Merck and US FDA, CDER and US FDA, CDER and Shionogi, Inc.

Abstract

Drug development has rapidly been globalized. Multi-regional clinical trial (MRCT) for regulatory submission has widely been conducted in the ICH and non-ICH regions. Regulatory agencies currently face challenges in evaluating data from MRCTs for drug approval. In order to harmonize points to consider in planning/designing MRCTs and minimize conflicting opinions, an ICH working group was established in late 2014 to create an international guideline for MRCT (ICH E17). In September 2016, the US FDA announced the draft guidance entitled ''E17 General Principles for Planning and Design of Multi-Regional Clinical Trials''. The draft guidance describes general principles for planning and designing multi-regional clinical trials (MRCT). MRCTs conducted according to the guidance will investigate treatment effects in overall populations with multiple ethnic factors (intrinsic and extrinsic factors as described in the ICH guidance entitled ''E5 Ethnic Factors in the Acceptability of Foreign Clinical Data." This half-day short course will (1) review regulatory history in ICH and non-ICH regions regarding the MRCT; (2) describe the key contents in the draft ICH E17 guidance; (3) discuss the statistical methodologies in designing MRCTs; and (4) illustrate the relevant concepts using case studies. This will be lectured by Drs Lisa LaVange , Aloka Chakravarty, William Wang, and Bruce Binkowitz. Dr LaVange, Dr Chakravarty and Dr Wang are members of the ICH E17 working group. Dr Binkowitz is the co-chair of the Society-of-Clinical-Trial MRCT Consistency Expert Working Group.