National Comprehensive Cancer Network

Educational Events & Programs

Data Needs in Oncology – Clinical, Regulatory, Coverage, and Policy Issues

Click here for the white paper.

The collection and subsequent use of data for clinical, regulatory, and coverage decision-making in oncology is of great interest to many stakeholders, including providers, payors, patients, and regulators. Rising health care costs and continued concerns about safety and quality have resulted in the demand for more data and evidence by payors and providers alike. A common foundation of high-quality data that are available in real time can simultaneously be used to improve clinical care, yield quality measurements, and focus research effort, all of which are high priorities for stakeholders.

On Friday, October 5, 2012, NCCN held the NCCN Oncology Policy Summit: Data Needs in Oncology – Clinical, Regulatory, Coverage, and Policy Issues at the National Press Club in Washington, D.C. The policy summit provided a forum to identify and address issues and concerns across the spectrum of data collection and utilization. The event brought together key stakeholders, including providers, patient advocates, payors, regulators, and industry representatives, all of whom were interested in examining the way data and evidence are generated, collected, aggregated, and applied in oncology for clinical, regulatory, and coverage decision-making.

Prior to the policy summit, NCCN assembled the NCCN Data Needs Work Group – a multidisciplinary, diverse group comprised of thought leaders from NCCN Member Institutions, as well as patient advocates, and representatives from manufacturers, payors, and government agencies. The function of the group is to identify and discuss challenges and provide recommendations–where possible–on the above mentioned topics. Ultimately, the focus of this initiative is to advance the evidence base for cancer treatment and to examine the way evidence is generated, aggregated, and applied in all types of decision-making.

The policy summit was comprised of multiple presentations and three roundtables with an opening presentation given by Mara Bloom, JD, MS, of Massachusetts General Hospital Cancer Center, in which she reviewed the issues, concerns, and recommendations identified by the NCCN Data Needs Work Group. Subsequent presentations highlighted innovative data repositories. Presenters included Amy Abernethy, MD, Duke Cancer Research Program; Elaine Jeter, MD, Palmetto GBA, LLC; Joel Kallich, PhD, Amgen, Inc.; and Elaine Yu, PharmD, Genentech, Inc.

Three roundtables moderated by Clifford Goodman, PhD, of the Lewin Group, focused on diverse areas, including patient perspectives on the collection and use of data, regulatory aspects of data generation and use, and the use of payor-collected data for coverage decision-making. The first roundtable centered on the use of patient-reported data in clinical decision-making and included discussion on how this type of data is collected and used by physicians making clinical decisions for patient care. Physician panelists included Dr. Abernethy; Peter Bach, MD, MAPP, Memorial Sloan-Kettering Cancer Center; and Stephen Edge, MD, Roswell Park Cancer Institute. Patient advocate representatives Susan Krivacic, PBG Consulting, LLC, and Mary Lou Smith, JD, MBA, Research Advocacy Network, discussed the importance of this type of data collection and utilization to the patient experience.

The second panel discussion addressed data generation and utilization in regulatory decision-making. Panelists, including Suzanne Demko, PA-C, U.S. Food and Drug Administration (FDA); Erling Donnelly, PhD, Pfizer, Inc.; Joyce Niland, PhD, City of Hope Comprehensive Cancer Center; Pamela Swatkowski, Abbott Molecular, Inc.; and Andrew von Eschenbach, MD, Samaritan Health Initiatives, Inc., discussed data standards for regulatory submissions, including Clinical Data Interchange Standards Consortium (CDISC) standards and how industry is transitioning to these standards. The FDA Janus clinical trial repository was also a topic of discussion.

Dr. Bach; Dr. Jeter; Kimary Kulig, PhD, MPH, NCCN; Bryan Loy, MD, Humana, Inc.; and Lee Newcomer, MD, UnitedHealthcare Group, Inc., participated in the final roundtable of the day. The focus of this roundtable was payor-collected data and its use in coverage decision-making, as well as for other uses. Discussions included the attributes and drawbacks of claims data, and efforts towards combining claims data with additional data sources.

The collection and subsequent use of data for clinical, regulatory, and coverage decision-making in oncology is an issue of great interest to many stakeholders and was quite evident at the summit. A White Paper entitled, Data Needs in Oncology: ''Making Sense of The Big Data Soup'' has been published by JNCCN as a supplement to the April 2013 issue.

Click here for the white paper.