PhRMA BioResearch Monitoring Committee Perspective on Acceptable Approaches for Clinical Trial Monitoring
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PhRMA BioResearch Monitoring Committee Perspective on Acceptable Approaches for Clinical Trial Monitoring The integn’ty of clinical research data is critical for making sound regulatory decisions regarding the approval and use of medications. Equally important is the safeguarding of hu-
Rolamd W. Usher, MS Principal Fellow, US Regulatory Affairs, Eli Lilly 6.Co., Indianapolis. Indiana
Key Words Data integrity; Quality; Clinical trial monitoring; Clinical research; BIMO modernization;Critical Path Correspomdeao Address Roland W. Usher, Lilly Corporate Center, 893 South Delaware, D/C 2543, Indianapdis. IN 46225 (email: RWUsher@ Lilly.corn).
man subjects in clinical trials. A key element in the generation of high-quality data and protection of research participants during clinical research is sponsor monitoring of the clinical investigator site. This article provides the current thinking of the PhRMA BioResearch Monitoring Committee on acceptable approaches to
IN T R O D U C T l O N In 2006 the US Food and Drug Administration (FDA) initiated the Human Subject Protection (HSP)/Bioresearch Monitoring (BIMO) Initiative as a new Critical Path Initiative. The HSP/ BIMO Initiative was aimed at modernizing and strengthening the agency’s oversight and protection of subjects in clinical trials and the integrity of resulting data (FDA website, http:// www.fda.gov/ScienceResearch/SpecialTopics/ RunningClinicalTrials/ucm U4452.htm). In May 2007 the FDA cosponsored with the Drug Information Association (DIA) a public forum titled Defining and Implementing Quality in Clinical Investigations From Design to Completion. The primary intent of this workshop was for interested stakeholders to provide feedback to FDA on what parts of the BIMO program (regulation or guidance) were in need of modernization. One topic that received considerable discussion was the different types of clinical trial monitoring systems in place today (eg, industry versus some government agencies). This led to another public meeting in June 2008 specifically focused on the topic of clinical trial monitoring, with the intent of beginning to describe acceptable approaches to monitoring. Subsequent to this meeting, FDA
clinical trial monitoring, taking advantage of risk-based decision making and modem techndogical tods. The intent is toprovidepexibility in approaches-given the broad diversity of types of clinical research-while maintaining high standards for quality and integrity. The PhRMA BioResearch Monitoring Colnmittee believes such approaches are applicable to all tvpes of clinical research, regardless of who is sponsoring or conducting the research (indusby, academia, orgovernment agenq).
and Duke University collaborated to create a new public-private partnership titled the Clinical Trial Transformation Initiative (C’ITI). One of the first projects funded by CTTI was a comprehensive review of clinical trial monitoring. The goal of this project was to advocate on behalf of best practices and provide regulators with sensible criteria for effective mo
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