Coordinating Data Monitoring Committees and Adaptive Clinical Trial Designs
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Jay Herson, PhD Senior Associate, Biostatistics. Bloomberg School of Public Health, johns Hopkins University, Baltimore. Maryland
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Coordinating Data Monitoring Committees and Adaptive Clinical Trial Designs
Key Words Data monitoring committee; Data analysis center; Internal safety review committee; Adaptive design Correspondence Address jay Herson, PhD, Biostatistics, Bloomberg School of Public Health, johns Hopkins University, 615 North Wolfe Street. Baltimore. MD 21205 (email: [email protected]). Presented at First Annual DIA/FDA Statistics Forum, Bethesda. Maryland, March 5-
7,2007. The Drug Information Association is accredited by the Accreditation Council for Continuing Medical Education (ACCME) to provide continuing medical education for physicians. The Drug Information Association designates this educational activity for a maximum of I AMA PRA Category 1 Credit(s)TM.Physicians should only claim credit commensurate with the extent oftheirparticipation in the activity. Ifyou would like to receive a statement ofcredit,you must review the article, and complete the post-test and evaluation included on the DIA website. Participants must receive a passing score of 80%or better on the post-test in order to receive a statement of credit. To access the post-test and evaluation.please visit the DIA website at ww.diahome.org, select Educational Offerings. then select Continuing Education from the drop down menu, and the My Transcript link. This will takeyou to the My Transcript page where you will be prompted to sign-in usingyour DIA usemame and password. Once signed-in.you may select the Coordinating Data Monitoring Committees and Adaptive Clinical Trial Designs link. You will be prompted to complete the post-test and evaluation. Upon successfulcompletion of the post-test,you will be able to download your statement ofcredit. Ifyou are not a DIA custome,: please contact the DIA ofice at mytranscriptQdiahome.orgfor a registration form. '&re is no fee to receive your statement ofcredit.
INTRODUCTION The use of the data monitoring committee (DMC) in pharmaceutical industry clinical trials has become standard over the past 20 years (1-3). Recently there has been considerable interest in employing adaptive clinical trial designs for drug development (4,s). Advances in computing power and pressures for shortening the drug development cycle have led to many publications and conferences on this topic. Changes will be needed in trial logistical management in order to accommodate adaptive de-
signs. One often-overlooked area is the use of DMCs in a clinical trial with an adaptive design, especially when adaptation is based on efficacy alone. Sponsor personnel who propose adaptive designs usually have little or no experience in serving on a DMC. This article is motivated by the author's 20 years of experience in serving as the statistical member of DMCs.
THE PROBLEM Let us assume that a DMC consisting of three physicians and a biostatistician is meeting three times per year by teleconference or in person to
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