FDA Pledges Funding For Clinical Trials Improvement Initiative

By Nick Otto

The FDA says it will infuse as much as $37.5 million to aid the Clinical Trials Transformation Initiative (CTTI) in its mission to enhance the efficiency and quality of clinical trials.

According to a Federal Register notice published May 23, sponsors have until June 30 to apply for the multi-year grants. The goal of the program is to develop an administrative and scientific infrastructure to support the creation and execution of a series of projects through CTTI, ultimately increasing the quality and efficiency of clinical trials.

Regulatory Focus says the broader intent of CTTI is to find solutions to common problems, which any one company or entity would ordinarily find prohibitively expensive.

CTTI was created in 2007 through a memorandum of understanding between the FDA and Duke University as a public-private partnership to identify and promote practices that will improve clinical trials. CTTI’s broad membership includes stakeholders from government, industry, patient advocacy and consumer groups, professional societies, clinical research organizations, and academia.

According the Federal Register notice, the following activities are examples of what could be supported by the grant:

• Maintaining an adequate administrative and scientific infrastructure to implement all related projects under the CTTI effort.
• Identifying and/or hiring a sufficient number of qualified personnel to conduct activities, including project management, such as review of project milestones for degree of completion, preparation/reporting of project findings, periodic and final reports, and for subsequent distribution in the public domain.
• Developing plans for the conduct of identified projects.
• Identifying, securing, and/or building, and effectively leveraging other resources for the conduct of identified projects.
• Upon completion of a given project, generating project results and recommendations and proposing related studies/projects, if needed, to build on the findings of the project and continuing to leverage established resources and personnel.

The grant, through a partnership between the FDA’s Center for Drug Evaluation and Research and the Office of Medical Policy, will be phased in over a five-year time frame and will be awarded to the Duke Translational Medicine Institute at Duke University, where the CTTI is based.

Through the multiyear grant, the FDA intends to fund up to $7.5 million per year in total costs, starting in fiscal 2014, contingent upon the availability of funds. Funding beyond the first year will be noncompetitive and will depend on satisfactory performance during the preceding year and the availability of federal fiscal year funds.