Resources

White Papers

Optimizing the use of Data Monitoring Committees in Clinical Trials

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Author: Alan Hopkins
Date: December 2002

Abstract: Data Monitoring Committees (DMCs) are being used more and more frequently in industry-sponsored clinical trials. DMCs are being requested frequently by institutional review boards (IRBs) and are becoming standard in trials with endpoints of mortality or irreversible morbidity. The added complexity of an external monitoring committee is discussed and some best practices are recommended. Implications of using a DMC by the sponsor project team is considered.

Now FDA has developed a Draft Guidance on the establishment and use of clinical data monitoring committees. We discuss this guideline through the lens of key parties involved in the clinical trial.

Clinical Informatics: Managing the Technical Infrastructure for Clinical Drug Development

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Author: Alan Hopkins
Date: August 2003

Abstract: The scope of clinical and regulatory informatics (CRI) comprises the processes of data collection, aggregation, integration, analysis, review, and regulatory publishing of clinical trial data and results. These activities are critical to business success, but we believe that companies invest large amounts of capital in technologies but do not receive a commensurate return on investment. This document serves as a perspective for companies just entering clinical development for the first time and as training material for those new to large pharmaceutical operations.

The Statistical Computing Environment

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Author: Alan Hopkins

Abstract: Statistical processing of clinical trial information into final reports is an are where practice has largely been ignorant of 21 CFR Part 11. We believe the whole data analytic process needs to be transparent and traceable. This paper discusses some of the issues related to specification, execution, quality, and documentation of statistical computing for clinical trials.