Harvard Schering-Plough Workshop

Bruce Binkowitz, Ph.D.

Senior Director, Late Development Statistics, Merck & Co.

An Overview of Issues Surrounding Multi-Regional Clinical Trials

Abstract

The conduct of a Multi-Regional Clinical Trials (MRCTs) presents significant challenges for those conducting the trial and those who need to make public health decisions based on the trial outcome.  MRCTs promise efficiency and cost savings by allowing a near simultaneous global registration of a new product using a single data package. However, to achieve this the quality and integrity of the data needs to be assured regardless of where the MRCT was conducted. Following discussions at the FDA/PhRMA meeting on the "Challenges and Opportunities of Multiregional Clinical Trials" held October 2007 in Maryland, a PhRMA MRCT Working Group was formed to address clinical, ethical, operational, statistical, and regulatory issues raised by MRCTs. This presentation will give an overview of issues regarding MRCTs, with specific mention of current areas of research by the PhRMA multi-regional clinical trial group. The PhRMA MRCT group welcomes comments and feedback on this presentation, and encourages partnerships with those in academia interested in improving MRCTs.

Biosketch

Bruce Binkowitz is a Senior Director in Late Development Statistics (phases II through V) at Merck and Co., Inc. He currently heads the Late Development Statistics Cardiovascular Franchise, which is globally responsible for all products under the broad cardiovascular therapy area, including atherosclerosis, hypertension, and heart failure products. In 23+ years of industry experience he has had a wide variety of health authority interactions during the development and approval of compounds worldwide across broad and diverse therapeutic areas including oncology, respiratory, metabolism/diabetes, dermatology, ophthalmology and endocrine. Dr. Binkowitz is  currently serving the first 1 year of a 3 year term as a member of the PhRMA Biostatistics and Data Management Technical Group. He is also co-chair of the PhRMA multi-disciplinary expert group focusing on issues surrounding Multi-Regional Clinical Trials.