On the Independence of Data Monitoring Committee in Adaptive Design Clinical Trials

Author:

Chow Shein-Chung1,Corey Ralph1,Lin Min1

Affiliation:

1. a Department of Biostatistics and Bioinformatics , Duke University School of Medicine , Durham , North Carolina , USA

Publisher

Informa UK Limited

Subject

Pharmacology (medical),Pharmacology,Statistics and Probability

Reference11 articles.

1. Data Monitoring in Clinical Trials

2. Data Monitoring Committees in Clinical Trials

3. Reporting Conflicts of Interest, Financial Aspects of Research, and Role of Sponsors in Funded Studies

4. Food and Drug Administration . ( 2006 ). Guidance for Clinical Trial Sponsors:Establishment and Operation of Clinical Trial Data Monitoring Committees.CBER/CDER/CDRH, U.S. Food and Drug Administration, Rockville, MD .

5. Food and Drug Administration . ( 2010 ). Guidance for Industry. Adaptive Design Clinical Trials for Drugs and Biologics. CBER/CDER/CDRH, The United States Food and Drug Administration, Rockville, MD .

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