Overview
The NCI Community Oncology Research Program (NCORP) Inaugural Investigator’s meeting was held at the NCI Shady Grove facility in Rockville, MD on September 22, 2014. Interestingly, this is a beautiful new Leadership in Energy & Environmental Design (LEED) Gold facility. I’ll give high level overview of the meeting.
Introductions and overview by NCORP leadership including Barry Kramer, MD, MPH, and Worta McCaskill-Stevens, MD, MS, noted changes from prior Community Clinical Oncology Program (CCOP) and National Cancer Institute Community Cancer Centers Program (NCCCP) structures. The NCI has published “An Overview of NCI’s National Clinical Trials Network (NCTN).” There is a shift from expansion in primary sites (as in the NCCCP) to an 842 component and subcomponent network that includes large health systems as well as consolidated CCOP and NCCCP sites. This can be visualized on the yet to be released interactive NCORP map that allows viewing by different site characteristics and subcomponent sites.
The NCORP budget includes $42.7 million to 46 NCORP community sites.
Cancer Care Delivery Research (CCDR)
Cancer Care Delivery Research (CCDR) is a major new initiative for NCI. Comments included that we have been doing CCDR, we just didn’t call it that. Dr. Kramer noted that we are moving from a "can it work" (efficacy) to "does it work" (effectiveness) focus in NCORP in addition to traditional treatment trials.
Questions from the sites included how this would be funded. The answer included current NCORP funding as well as in the future the potential for blended funding from NIH (e.g., RO1) as well as non-NIH dollars (e.g., American Cancer Society, Livestrong, Patient-Centered Outcomes Research Institute) utilizing the NCORP network. Rachel Ballard-Barbash, MD, MPH, noted prior efforts and large data networks including the Surveillance, Epidemiology, and End Results (SEER) program and NCI virtual data warehouses. Dr. Ballard-Barbash thought that CCDR was timely in the context of efforts from the Institute of Medicine (IOM) and Choosing Wisely Campaigns from organizations such as ASCO and ASH. Local resources such as electronic health records (EHRs) could be leveraged with QOPI and registries as well as incorporate genomics and other “-omics.”
Multiple areas were reviewed under CCDR including: patient navigation, care coordination, multi-disciplinary conferences (MDCs), genetic counseling, adding patient reported outcomes (PRO) data into electronic health records. Penny Mohr, MA, presented “Opportunities for Collaboration with the Patient-Centered Outcomes Research Institute (PCORI).” CCDR is aimed at system level interventions rather than at individuals, but can include evaluating and modulating individual risk behaviors such as tobacco use and obesity including leveraging tele-health.
Implementing Precision Medicine Treatment Trials within NCTN
Drs. McCaskill-Stevens and Margaret Mooney, MD, MBA, discussed activated and future NCI molecular studies including the concepts of: Basket (e.g., MATCH -- different cancers, separate study arms, single drug, single mutation), Umbrella (Lung-MAP & ALCHEMIST, single cancer, different drugs, different mutations), and Exceptional Responders Pilot Study (-omics in exceptional responding patients). Other study types include an MDS national registry. Apparently NCI MATCH is expected to open for accrual in Q1 2015, not November 2014 as previously noted at the last ECOG-ACRIN meeting. Molecular studies will pay for screening biopsies.
Cardiotoxicity
Lori Minasian, MD, updated us on the NCI Community Oncology Cardiotoxicity Task Force. This tied in to many prior and future NCORP research base studies involving the cross-disciplinary collaborations of cardiology and oncology. The focus on cardio-oncology toxicity was related to the increase in cancer survivors. Future studies will incorporate standardized assessments and endpoints. The Symptom Management and Quality of Life (SxQOL) Steering Committee (SC) recommendations were to strengthen the preclinical foundation for trials and to conduct fewer trials using novel approaches.
Cancer Prevention and Control Research Agendas
The NCORP research bases included reviews of prior studies, open studies, and future concepts. While this was very detailed, information is or will be available on those websites and change over time.
I previously mentioned studies from URCC.
Upcoming NCORP RB meetings are coming for Wake Forest, Alliance and ECOG-ACRIN.
Patient Log and EDRN
Cynthia Whitman, Diane St. Germain, RN, MS, and Sudhir Srivastava, PhD discussed NCORP grant funds, patient logs and the EDRN - Early Detection Research Network. The NCCCP used a screening and accrual log to address cancer clinical trial accrual (JOP 2014) A patient log may be used in NCORP, but focused on cancer control, prevention, and CCDR. Four EDRN-related RFAs are coming including for component CVCs - Clinical Validation Centers - looking for high quality samples.
CT AIM
Stephen Grubbs, MD, Bryan Weiner, PhD, and Eileen Dimond, RN, MS, discussed the Clinical Trial Assessment of Infrastructure Matrix Tool (CT AIM). Data was presented at the ASCO 2014 meeting by Dimond et al. Abstract 6512. CT AIM “showed utility across the sites for promoting quality improvement, benchmarking research performance, progress reporting and providing metrics for communicating infrastructure needs. Use in research beyond oncology and outside the community setting is plausible.” CT AIM will be further discussed at the upcoming (9/28-29/2014) ASCO Community Research Forum.
NCI CIRB
Linda Parreco, RN, MS, bravely was the last full presentation of the day and discussed the history of the NCI Central IRB (CIRB). In 2013 an “early phase” group was added and the CIRB received AAHRPP accreditation. In January 2015 the NCI CIRB will include Cancer Prevention & Control Studies. Plans are for future CCDR studies via the NCI CIRB as well.
Conclusions
The changes in the NCTN and CCOP/NCCCP moving to NCORP have been fast, disruptive, flatly funded (mainly) and not without consternation in many areas of the cancer research community. This meeting did seem to allay some worries, lay groundwork for implementing the new structure and highlighted future priorities. My gut feeling was that many people did leave more excited and energized than before they started. I did. Funding is lean, but with new opportunities.
More emphasis will be on CCDR, cancer control and cancer prevention studies. Cross-disciplinary collaboration (e.g., Cardio-Oncology, neuropathy, exercise/metabolism, etc.) will increase and work on standardizing assessments and endpoints as well as coordinate to prevent study overlap. Molecular studies, increasing analysis of accrual barriers (e.g. CT AIM), and efficiencies such as NCI CIRB will help us.
More terse notes and links are included in my #NCORP tagged tweets at the meeting. I also started using #CCDR as a Twitter hashtag.
