449 Harmonization operations for global trials to overcome obstacles from 2004 – 2017: gynecologic cancer intergroup (GCIG)

Abstract

Objectives The Gynecologic Cancer InterGroup (GCIG) is a global consortium consisting of research groups from various countries to facilitate collaboration in clinical trials in gynecologic cancer; founded in 1993 and formalized in 1997. Global clinical trials often have multiple obstacles for operating them. To address such issues, the GCIG established a Harmonization Operations Committee in 2003. Achievements of this Harmonization committee are summarized. Methods Minutes of GCIG meetings between 2004 and 2017 were reviewed. Participating member groups and Harmonization activities were summarized. Results The average numbers of participant groups were 10.8 from 2004 to 2008, 17.0 from 2009 to 2013, and 19.1 from 2014 to 2017. The participant groups originated from Europe, North America, Latin America, Oceania and Asia. Total number of activities was 69. The major activities were aimed at overcoming international variations in managing clinical trials (eg. budgeting, insurance, data quality, communication amongst groups, etc.). The committee developed common templates, tools and policies, as well as minimum standards of data quality for GCIG trials, in order to facilitate intergroup collaboration. The committee also addressed issues in rare tumors, translational research and QoL/PRO instruments. Education, including mentoring, is ongoing. Conclusions With growing recognition of the importance of operational harmonization in international trials, more groups have been participating in the Harmonization Committee. The committee has been challenging problems towards improving outcomes for patients. This review showed that operational harmonization is an essential component of successful international trials. The Harmonization Committee will continue to enhance high quality clinical trials for gynecologic cancer patients.