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IC Directors' Meeting Highlights

June 19, 2006

To:	IC Directors
From:	Deputy Director, Executive Secretariat
Subject:	IC Directors' Meeting Highlights — April 13, 2006

Discussion Items

I. Transformation of the Commissioned Corps (Corps)

Dr. Zerhouni introduced ADM John O. Agwunobi, the Assistant Secretary for Health, in which role he serves as the Secretary’s primary public health advisor and oversees the USPHS and the Corps. ADM Agwunobi explained that he has been tasked with overseeing the current transformation of the Corps, intended to —

• increase its ranks,
• streamline its assignment and deployment process, and
• increase its ability to recruit the best and brightest to defend the Nation's public health.

• the President’s personal attention,
• the Nation’s experiences during various crises this past year, including Hurricanes Katrina and Rita, and
• the Surgeon General’s deep commitment to and vision of the Corp’s leadership role in national emergencies and in scientific research.

RADM Robert Knouss then summarized the findings of the report of the five workgroups (Readiness, Sizing, Recruitment and Training, Assignments, and Classification and Billets) representing all agencies.

Dr. Zerhouni opened the floor. Questions and discussion addressed concerns and suggestions such as —

• how mandating that clinical positions be filled as they come open by Corps officers would compromise NIH operations;
• what effect the transformation might have on the NIH Clinical Center’s commitment to deploy a Field Medical Station in conjunction with the National Naval Medical Center and Suburban Hospital;
• how current retirement requirements negatively affect recruitment of junior officers;
• the need for more flexibility commensurate with the realities of NIH senior scientific careers; and
• the possibility of expanded loan repayment incentives or other ways to help recruits through medical and graduate school.

Invoking the metaphor of cell apoptosis, Dr. Zerhouni urged that the transformation consider the whole cycle of a Corps career, from recruitment through retirement. He also mentioned other potential flexibilities that would encourage recruitment and result in a win for the individual, a win for the Corps, a win for the institution, and a win for the public health.

II. Clinical Network Efficiencies Subcommittee (CNES)

Dr. Duane Alexander, Chair of the CNES, reported on its activities over the past year. The Subcommittee, whose members represented key NIH stakeholder communities, had been asked to —

• examine the inventory of clinical research networks being compiled by Westat under contract for the Roadmap;
• consider listing the roster of clinical research networks (CRNs) in a searchable format that would make it useful for Health Science Administrators seeking characteristics of existing networks to identify those that might serve as the locus for a proposed new multisite clinical research project or clinical trial;
• explore ways to utilize the Early Notification System and a comparable system for contracts to serve as a mechanism to assure that consideration has been given to using existing networks for a clinical project before an Institute starts a new network;
• gather information on how other agencies (e.g., Veterans Administration) use networks for clinical studies;
• consider how a future National Clinical Research Associates program might fit into this resource of networks; and
• consider the potential benefits of a ready resource of pre-qualified Data and Coordinating Centers for managing clinical trials to speed the process of contracting for such services.

Dr. Alexander described information-gathering and discussion stages. He next reported that the group has concluded that NIH could make better use of existing mechanisms to increase the efficiency and effectiveness of CRNs and that the NIH needs to be proactive on tracking emerging activities and, when appropriate, integrating these activities.

The final recommendations are as follows:

Recommendation 1: Support the continued development and maintenance of the electronic data base for the Roadmap inventory of CRNs.

Recommendation 2: Encourage IC Program Officials to use the CRN inventory to search for candidate networks for their new trials before developing plans to create a new CRN, and evaluate the utility of such use with a view toward documenting this search if creation of a new network is proposed.

Recommendation 3: Develop and implement a plan to train contracting officers and program officers in the IDIQ mechanism, including how to apply it to support clinical trials, especially multisite trials.

Recommendation 4: Present to the IC Directors the case for the cost-effectiveness and efficiency of the IDIQ mechanism for funding clinical research infrastructure, encouraging them to make a similar case to their Program Officials.

After discussion, Dr. Zerhouni thanked Dr. Alexander and the Subcommittee members and took the recommendations under advisement.

Dale Johnson
cc: OD Senior Staff

This page was last reviewed on September 21, 2006 .

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