סדנא: הבטים סטטיסטיים בקווים המנחים להערכת יעילות תרופות

Introductory overview to the statistical aspects of the "International Conference on Harmonization Efficacy Guidelines"

By Prof. Allan Sampson, Pitsburgh University

Wednesday, June 4, 8:30-11:30, Hasharon Hotel, Hertzeliya. Please register by May 24

This mini-workshop will provide an introductory overview of the International Conference on Harmonization (ICH) Efficacy Guidelines, with the primary emphasis being on their statistical aspects. As a whole the ICH Guidelines have had a major impact on biopharmaceutical research worldwide. To familiarize attendees with the ICH, we begin with a brief historical summary concerning the ICH. We will then proceed to consider the main statistical considerations in the ICH Efficacy Guidelines. Necessarily, with the exception of the E9 Guideline (“Statistical Principles for Clinical Trials”), only the more important statistical highlights of these can be touched upon. The major focus of the workshop is on E9 and we will provide a detailed examination of this highly influential statistical guideline. This workshop is intended for statisticians who have some familiarity with clinical trials and who want to familiarize themselves with the ICH and its statistical impact upon biopharmaceutical clinical development

This workshop instructor is Allan Sampson, who is a professor in the Department of Statistics and the Department of Biostatistics at the University of Pittsburgh. Prior to the University of Pittsburgh, he also worked in the pharmaceutical industry. Dr. Sampson currently also consults for multinational pharmaceutical companies and has served on U.S. Food and Drug Administration Advisory Committees. At the University of Pittsburgh, he introduced and teaches a graduate statistics course focusing on the ICH guidelines and related statistical research issues. Dr. Sampson has over 120 publications, many relating to clinical trials issues