Operational Efficiency Initiatives

Improving operational efficiency is essential for the cancer clinical trials system to fulfill its promise to deliver new treatments to patients more quickly. There are two critical areas in which operational efficiency could be enhanced. The first is to increase the rate of patient accrual so that trials can be completed in a more timely fashion. The second is to identify and reduce institutional barriers that prolong the time from concept approval to opening of patient accrual at sites.

Opportunities for increasing the rate of patient accrual include aligning NCI funding more closely with the actual cost of conducting a trial; creating incentives for high accruing, cost-efficient sites; educating patients and the public about the benefits of clinical trials; and improving access of minority populations to clinical trials. Reducing the time required to conduct clinical trials requires a systematic analysis of institutional and regulatory obstacles to trial initiation and execution.

For full details on the initiatives, see the CTWG Report (PDF - 366KB).

The CTWG Operational Efficiency Initiatives

Initiative 1: Restructure the funding model for phase III efficacy trials to create incentives for more rapid rates of patient accrual.

Initiative 2: Identify the institutional barriers that prolong the time from concept approval to the accrual of the first patient, and develop solutions for overcoming these barriers.

Initiative 3: Promote patient and public awareness and understanding of clinical trials.

Initiative 4: Expand current outreach programs to increase the recruitment of minority populations to cancer clinical trials.

Initiative 5: Develop approaches for enhancing adoption of centralized Institutional Review Board processes.

Operational Efficiency Initiatives-Key Accomplishments

• Report of the Operational Efficiency Working Group (OEWG)

  To dramatically improve the current process of activating new clinical trials, NCI's Clinical and Translational Research Advisory Committee (CTAC) initiated a review of the clinical trial activation process. On March 23, 2010 CTAC's Operational Efficiency Working Group presented its final report, outlining a series of recommended changes to NCI's current clinical trials activation procedures. These changes aim to decrease, by at least half, the time it takes to initiate new clinical studies.

  OEWG Final Report

  NCI Cancer Bulletin April 6, 2010

• NCI funded a study by Drs. David Dilts and Alan Sandler of Vanderbilt University to identify institutional barriers to the initiation of clinical trials. They gathered data on the steps taken to activate clinical trials, compared the responses of study leaders to the policies and procedures manuals at the institutions conducting the trials, and then compared this to what actually occurs in the initiation of a trial. The results have been published.

  Development of Clinical Trials in a Cooperative Group Setting: The Eastern Cooperative Oncology Group, Dilts et al. Clinical Cancer Research, 14(11) June 1, 2008

  Processes to Activate Phase III Clinical Trials in a Cooperative Oncology Group: The Case of Cancer and Leukemia Group B, Dilts et al, Journal of Clinical Oncology, 24(28) October 1, 2006

  Invisible barriers to clinical trials: the impact of structural, infrastructural, and procedural barriers to opening oncology clinical trials. Dilts and Sandler, Journal of Clinical Oncology 24(28) October 1, 2006

• The CTWG Report stated that it is vital that minority populations be better represented in cancer clinical trials and called for the expansion of best practices for recruitment of minority populations by providing additional funding to proven initiatives such as the Patient Navigator Program associated with the Cancer Disparities Research Partnership (CDRP) Program; the Minority-Based / Community Clinical Oncology Program; Community Networks Program and the Minority Institution/Cancer Center Partnership program.

Since 2006, administrative supplements have been provided to selected grantees in these programs to increase funding for recruitment of minority and medically underserved patients to NCI clinical trials. Each year, proposals were solicited through NCI Program Staff for requests for administrative supplements to established programs from eligible grantees. In 2008, nine continuation supplements, totaling $830,000, and 4 new supplements at $399,000 were awarded.