NCCN News

NCCN Survey Analyzes Clinical Trial Accrual at Academic Cancer Centers

Clinical research is at the heart of National Comprehensive Cancer Network® (NCCN®) center operations, as it constitutes a core mission of NCCN Member Institutions. Although clinical trials are the cornerstone for advancing treatments in cancer, recruitment to clinical trials remains a considerable challenge even for leading NCCN academic cancer centers. To gain insight into the operations of Clinical Trials Offices (CTOs), protocol review processes, and patient accrual to clinical trials, NCCN conducted a Research Benchmarking Survey at NCCN Member Institutions in 2008 (reporting on 2007 data). Results from the survey were presented in poster format at the 2010 ASCO Annual Meeting in Chicago on June 7, 2010.

The 2008 NCCN Research Benchmarking Survey utilized clinical trials benchmarking metrics based on CTO budgets, full-time equivalents (FTEs), and patient accruals.

“Our primary goal was to benchmark CTO operations and processes at NCCN Member Institutions and use this data to identify best practices in academic cancer center clinical research operations,” said presenting author Stephen L. Sherman of NCCN.

The survey collected quantitative and descriptive data on patient accrual, CTO organization, research infrastructure, staffing, and clinical trials management. It also included questions on innovative approaches designed to increase accrual to clinical trials.

Results from 17 participating NCCN Member Institutions that submitted patient accrual data indicate that more than 16,000 patients were accrued to therapeutic clinical trials over a 12-month reporting period, translating to accrual rates ranging from 10 to 24 percent. Of these participants, minority accrual rates ranged from 6 to 28 percent.

The authors note that increasing minority accrual to clinical trials remains an ongoing priority among all NCCN Member Institutions.

In addition, the average CTO operating budget for 15 NCCN Member Institutions that provided funding information was $4.7 million, while the mean number of therapeutic accruals per CTO FTE was 10.6. Seven of the participating centers demonstrated best practices in implementing a value stream analysis of the protocol approval process. Value stream mapping is a process analysis and improvement technique used to analyze the flow of materials and information required to bring a product or service to a patient.

NCCN is currently conducting a 2010 version of the Research Benchmarking Survey. This survey has been refined to better evaluate the steps involved and overall timetable to open clinical trials, from protocol submission to patient accrual. NCCN plans to undertake longitudinal analyses of common data among the 2008 and 2010 Research Benchmarking Surveys.

“Clinical research is imperative to NCCN Member Institutions, yet it also represents one of the most significant challenges with many opportunities for improvement,” noted Sherman. “Continued development of benchmark data and best practices across these centers will promote enhanced operations and patient accrual in therapeutic clinical trials.”

Additional authors include Marcy B. Waldinger, MHSA, University of Michigan Comprehensive Cancer Center; and Eva. M. Lepisto, MSc; Jennifer M. Hinkel; Kristie A. Minogue; and Diane E. Paul, MS, RN, National Comprehensive Cancer Network.

Updates to the NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines™) and NCCN Drugs & Biologics Compendium (NCCN Compendium™) for Prostate Cancer

The NCCN Prostate Panel added sipuleucel-T as a category 1 treatment recommendation for patients with castration-recurrent prostate cancer. Sipuleucel-T is appropriate for asymptomatic or minimally symptomatic patients with ECOG performance status 0-1. It is not recommended for patients with visceral disease and a life expectancy less than 6 months.

Updates to the NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines™) and NCCN Drugs & Biologics Compendium (NCCN Compendium™) for Pancreatic Adenocarcinoma

The updated NCCN Guidelines have adopted the criteria for defining resectable and borderline resectable disease recently published by an expert consensus group (Callery MP, et al. Ann Surg Oncol 2009;16:1727–1733). The TNM staging system for pancreatic adenocarcinoma has also been modified for consistency with the 7th edition of the American Joint Committee on Cancer Staging Manual.

Updates to the NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines™) and NCCN Drugs & Biologics Compendium (NCCN Compendium™) for Cancer- and Chemotherapy-Induced Anemia

The updated NCCN Guidelines have been extensively revised to include indications for transfusion for patients with anemia of inflammation or anemia due to myelosuppressive chemotherapy for lymphoid malignancies and solid tumors. Special categories for considering ESA use and the management of functional iron deficiency are described.

For the complete updated versions of the NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines™) and the NCCN Drugs & Biologics Compendium (NCCN Compendium™), please visit NCCN.org.

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