By the numbers, the first year of NCI’s Community Oncology Research Program (NCORP) has made progress in clinical trials for prevention, control, health-related quality of life, comparative effectiveness and screening; accrual to NCI National Clinical Trials Network treatment and imaging trials; and in new areas of emphasis in cancer care delivery research and cancer disparities research.
At the annual meeting in late August, NCORP Director Worta McCaskill-Stevens, MD, highlighted the network’s advancement over the previous 12 months. The meeting provided a forum to share information about the implementation of the new network, which experienced significant changes following the restructuring of NCI’s national clinical trials program.
Overall, NCORP seeks to provide access to cancer clinical trials and cancer care delivery research (CCDR) studies to individuals in their own local communities, which is where most patients receive their care. The first year focused largely on developing NCORP infrastructure and resources such as systems integration efforts, central institutional review board (CIRB), trial stopping rules, cancer control biobanks, the NCORP portal, public website, interactive map, updated guidelines, webinars, and website badge. Key challenges that were overcome included: site rostering, populating “swim lanes,” and enrollment of 92% of sites to the new CIRB.
As of August 28, NCORP was running 47 active trials, of which 30 are legacy, and 17 were initiated since the start of the network. Of the new trials, 4 are in review and 13 are approved or activated. One is an international collaboration with the International Breast Cancer Study Group. In support of NCI’s new precision medicine program in NCTN, 240 affiliates of 13 NCORP sites accounted for 70% of all sites pre-registered to the NCI-Molecular Analysis for Therapy Choice (NCI-MATCH) trial launched Aug. 12.
“The first year of NCORP achieved the foundational objectives that will underlie the community-based network in the years ahead as it addresses the continuing need for evidence to identify and evaluate interventions that reduce cancer risk for healthy people and enhance quality of life and care for cancer patients,” Dr. McCaskill-Stevens said.
Meeting attendees included principal investigators, administrators and stakeholders, including representatives from the seven NCORP Research Bases that design and conduct multi-center studies and provide administrative and data management infrastructure, scientific and statistical leadership and regulatory compliance. NCORP sites, the consortia of community hospitals, oncology practices and integrated healthcare systems, comprise 46 grantees (34 Community Sites and 12 Minority/Underserved Community Sites) with 860 community-based component/subcomponent affiliate sites, and 394 CCDR affiliate sites. More than 3,900 investigators are involved.
The current portfolio of clinical trials covers broad topic areas, for example: adjuvant testosterone in treatment of women with aromatase inhibitor-induced arthralgias; pregnancy outcome and safety of interrupting therapy for women with endocrine responsive breast cancer; prospective MRI and gene expression assay in DCIS; pre-operative assessment and post-op outcomes of elderly women with gynecological cancers; prospective comparative effectiveness for malignant bowel obstruction, among others.
NCORP Makes Headway in CCDR
The new CCDR program made strides in the first year to develop and stimulate this new area of scientific investigation within NCORP.
“The first year focus of CCDR activities was to characterize and build capacity and infrastructure at the Sites to help them engage in this research,” Kate Castro, NCORP CCDR Operations Lead, said. “Also, we worked through the CCDR Coordinating Committee to develop a structure and process to both promote and coordinate scientific collaborations across NCORP.”
Formed in December 2014, the CCDR Coordinating Committee has representatives from seven Research Bases, four Community Sites, and three Minority/Underserved Sites. Working Groups were created in February 2015 to concentrate on metrics of participation and information technology. Other activities included reviewing areas of interest from the Sites, drafting research priorities, developing and disseminating non-study specific information to the network, cross-Research Base non-study-specific data collection to characterize CCDR resources, capacities and health information data assets of designated components and to inform CCDR concept development by the Research Bases.
In addition, the newly formed CCDR Steering Committee selected co-chairs, identified and vetted member candidates, selected members, began conducting scientific reviews of concepts in April and established scientific priorities for CCDR in the community-setting.
Integrating Disparities Research
Efforts to incorporate cancer disparities research into the NCORP network were devoted to the role of organizations in reducing disparities; utilizing resources from the Center to Reduce Cancer Health Disparities; and evaluating financial toxicities in cancer care.
Meanwhile, NCORP cancer disparities clinical trials initiatives included trans-Research Base collaborations; a joint position paper with American Association for Cancer Research, American Society of Clinical Oncology and American Cancer Society entitled “Charting the Future of Cancer Disparities Research;” a new clinical trials log, which will also collect expanded demographic information; and increasing representation of principal investigators in the minority and underserved NCORPs on NCI Disease and Non-Disease Steering Committees.
Going forward, a Cancer Prevention Think Tank is expected to reinvigorate cancer prevention research within NCORP and identify new cancer prevention concepts.