type of viewpoint offered at the workshop identified spillover benefits to conducting clinical trials in the United States. Trials are educational opportunities because knowledge of, or participation in, clinical trials facilitates dialogue among clinicians about developing medical evidence for new treatments or comparing products or interventions already in use. Clinical trials are also a source of jobs. And finally, clinical trials can result in improved clinical care for trial participants.

Building Consortia to Create Conditions for Change

When the U.S. semiconductor industry faced strong pressure from Japanese competition and other forces, a Semiconductor Manufacturing Technology consortium (SEMATECH) was formed to create elements of a single manufacturing infrastructure, supported with the pooling of funds and public–private partnerships. The consortium concept may be applicable to the challenges facing the CTE, according to Steele. The creation of consortia could enhance the current clinical trials infrastructure. Already the Biomarkers Consortium, managed by the Foundation for the NIH (FNIH), is developing common adaptive trial designs. The CTSAs and academic medical centers share training programs, improve common understanding about regulatory requirements, improve informatics, develop model clinical trial agreements, and achieve other infrastructure enhancements across the CTSA institutions. The consortia model also could help overcome cultural barriers to CTE transformation, by resolving problems in leadership and governance. For example, Steele suggested that a consortium could be developed to revamp the weighty IRB structure as currently used in clinical research. Interagency coordination also can be improved through coordinating councils with multiagency input.

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