HOME HELP FEEDBACK SUBSCRIPTIONS ARCHIVE SEARCH TABLE OF CONTENTS		QUICK SEARCH:   [advanced] Author: Keyword(s): Year:  Vol:  Page:
Sign In to gain access to subscriptions and/or personal tools.

This Article Full Text Full Text (PDF) All Versions of this Article: 0091270008319332v1 48/7/793    most recent Alert me when this article is cited Alert me if a correction is posted Citation Map Services Email this article to a friend Similar articles in this journal Similar articles in ISI Web of Science Similar articles in PubMed Alert me to new issues of the journal Download to citation manager Request Permissions Request Reprints Google Scholar Articles by Ameer, B. PubMed PubMed Citation Articles by Ameer, B.

Novel Trial Design: A Report From the 19th Frontiers Symposium of ACCP

From the University of Medicine and Dentistry of New Jersey, Robert Wood Johnson Medical School, Department of Medicine, New Brunswick, New Jersey.

Novel approaches to drug development along with incentives to reward risk undertaken during early drug development have been proposed to improve the medical product development process. The American College of Clinical Pharmacology held its 19th Frontiers Symposium in mid-2007 to provide a forum to share new knowledge about disease progression models and adaptive and other novel trial designs. These topics reflect the changing paradigm of drug development and regulatory innovation as outlined in the Food and Drug Administration's Critical Path Initiative. This meeting report summarizes some of the presentations and panel discussions among academic, industrial, and regulatory participants regarding clinical trial design, including adaptive Bayesian approaches.

Key Words: Trial design • drug development • Frontiers Symposium • statistics • regulatory

Address for reprints: Barbara Ameer, PharmD, MBA, BCPS, FCP, P. O. Box 818, Princeton Junction, NJ 08550-0818; e-mail: ameerbcps{at}gmail.com.