Results of a Survey of PhRMA Member Companies on Practices Associated with Multiregional Clinical Trials

Abstract

As part of the PhRMA Multiregional Clinical Trial Key Issue Team activities, a survey was designed, with the goal to collect actual data, experiences, practices, and examples, focusing predominantly on five key areas: the extent to which companies are expanding their reach into different regions to conduct clinical trials; the regions in which the studies are being conducted; the operational challenges experienced; management of differing, and often conflicting, regional requirements; and the sourcing models used to respond to the increasing global demands of staffing. The survey was sent to 31 PhRMA member companies on record at the time of the survey; responses were received for 15 of the 31. Nearly 80% of respondents had started trials in a new region over the last 10 years, mostly late-phase or postmarketing trials conducted across many therapeutic areas.

The number one driver for this trend is the need for faster recruitment, although sponsors are also responding to the need for data to meet regional requirements. Evidence from the survey would suggest that the operational challenges of conducting trials in multiple regions are related to the mechanics of study conduct. Different methods of training are employed to drive quality of research, and such methods include formal tools such as online or instructor-led training, Role certification, and the use of meetings and teleconferences. The survey also showed that differing and sometimes contradictory health authority or regional requirements present barriers to efficient clinical research, and harmonization among regulators would be beneficial to conducting global clinical trials.