QRTI Newsline --- Wednesday September 8, 2010

FDA & Duke Create Think Tank to Modernize the Mechanics of Clinical Trials.

By Rochelle L. Goodson

The FDA and Duke University are collaborating on efforts that will strengthen human subject protection by systematically modernizing the clinical trial process, as outlined in the Clinical Trials Transformation Initiative (CTTI).

The intent of the CTTI is to provide a forum for participants to exchange ideas that will optimize the effectiveness of the research process, while improving safety for subjects and the quality of information derived from research.

Some of the concepts and ideas that the CTTI will explore are listed below:

• Establishment of a national standard for various research functions to enable a streamlining of initiating and conducting clinical trials;
• Exploration of alternative IRB models that minimize duplication of effort in multi-center clinical trials;
• Identification of strategies that can enhance the informed consent process;
• Establishment of accreditation program for clinical investigators and research sites; and
• Incorporation of new technologies that improve data management.

Some of the projects that the CTTI will consider undertaking are listed below:

• Reduction of voluminous paper records/elimination of paper CRF;
• Reduction/elimination of data transcription;
• Reduction of manual auditing;
• Assessment of possible approaches for more flexible study monitoring; and
• Development of a proposed model for the ideal clinical research site.

This partnership offers a mechanism for hosting representatives from government, industry, patients and patient advocacy groups, healthcare payers, professional societies and academia. Duke's primary role will be as a not-for-profit host to manage CTTI and coordinate interactions of all participants. FDA's role will be to provide scientific and regulatory expertise that is consistent with its Critical Path Initiative, FDA's national modernization effort through which FDA-regulated products are developed, evaluated and manufactured.

To obtain a comprehensive understanding of how the CTTI will identify the areas in clinical research requiring better procedures, their implementation and potential outcomes, go to http://www.fda.gov/oc/initiatives/criticalpath/clinicaltrials.html.

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