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NCI to Improve Infrastructure of Intramural Clinical Trials Program

NCI to Improve Infrastructure of Intramural Clinical Trials Program

BETHESDA, Md—National Cancer Institute officials have pledged to quickly correct deficiencies found in the infrastructure of its intramural clinical research program. A committee formed to evaluate the operations of NCI’s Division of Clinical Sciences (DCS) found that the NCI “had made progress in recent months [in correcting problems with the infrastructure] but still must implement several organizational changes to fully match the quality of the best research centers in the country.”

The Clinical Trials Advisory Committee, chaired by Elizabeth Eisenhauer, MD, of the NCI-Canada Clinical Trials Group at Queens University, Kingston, Ontario, attributed the problems “to a lack of centralization of some important functions that would establish steady and high standards of protocol development, resource allocation, patient enrollment and eligibility, protocol compliance, and data management and analysis.”

Dr. Eisenhauer stressed that the criticisms are of the clinical trials infrastructure and, as stated in the panel’s report, “are not meant to reflect on the caliber of science within the Division nor on the real efforts of NCI investigators to perform excellent clinical trials.” Rather, the panel lauded as exemplary the Division’s scientific contributions and the clinical care of cancer patients.

A Blueprint for Change

DCS officials told the National Cancer Advisory Board (NCAB) that they have already set about implementing the panel’s recommendations. “We are using this report as a blueprint for change,” said Edison Liu, MD, director of the DCS.

The report criticized the autonomy granted individual branches of the DCS, which “has impeded development of an adequate infrastructure and equitable distribution of resources while allowing continued recruitment to protocols with low accrual.” The committee urged DCS to:

  • Establish global oversight in setting research priorities, allocating resources, and centralizing and standardizing clinical activities.

  • Define a realistic number of studies to be conducted at any one time based on realistic accrual expectations.

  • Allow its protocol review and monitoring committee to exercise authority to assure the “establishment of DCS-wide research priorities and standards of scientific and statistical input.” Additional statistical support will be critical “to address the needs of future clinical trials such as novel trial design and endpoints.”

  • Consolidate clinical trial data management and analysis at the division level and establish a central data base, and enhance the resources and mandate of the protocol resource office. “The development of a centralized data base is critical to this effort and must move forward expeditiously,” the committee said.

  • Improve communications and patient referral among branches and communicate DCS findings with researchers outside the NCI “in a timely fashion” so that important findings can be studied in a broader context. “The current branch structure may not be optimal for facilitating research interactions and collaborations between like-minded investigators,” the review panel noted. “At a minimum, interbranch research groups should be encouraged.”

Gregory Curt, MD, DCS deputy director for clinical affairs, noted that the Eisenhauer committee has been invited to “come back in a year to review the steps that have been taken in response to these recommendations.”

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