by John Olson, MD, PhD
Director, University of Maryland Cancer Network
Associate Director, UMGCCC
Chief, Division of General and Oncologic Surgery, UMMC
Campbell & Jeanette Plugge Professor and Vice Chair of Surgery, University of Maryland School of Medicine

Cancer clinical trials are an essential if not central component of our society’s care of the cancer patient. Since the National Cancer Institute (NCI) conducted the first cancer clinical trials in the early 1950s and formed cancer clinical trials programs for leukemia (Acute Leukemia Group B, later CALGB) and solid tumors (Eastern Solid Tumor Group, later ECOG), our national clinical trials enterprise through its cancer treatment protocols has rationalized cancer care and created modern “evidence-based medicine” with the randomized clinical trial as the gold standard [1]. Over the years, the NCI Cooperative Group System has evolved from an organization devoted to testing compounds in limited research centers and universities to a wider cancer research enterprise engaged in the testing of therapeutic hypotheses, biomarkers, and preventive strategies.  Critical to the evolution of these activities was the expansion of clinical trials from academic centers to community hospitals where the vast majority of cancer patients were (and are) seen and treated. 

In an article published in Journal of Oncology Practice commemorating the 50th anniversary of the founding of ASCO, Zon and colleagues discuss the changing landscape of clinical trials research in our country [2]. The authors stress the historic importance of provider-based research networks (PBRNs) in our national research effort by noting that the NCI’s Community Clinical Oncology Programs (CCOPs) contributed a third of therapeutic trial enrollment and virtually all of NCI cancer prevention trial enrollment. They cite an underpinning philosophy for success that “common cancers should be treated at the local level and that cancer trials need to be tailored to community needs.” Against this backdrop of achievement and the changing dynamics of cancer research, the authors go on to discuss the Institute of Medicine (IOM) report that challenged us to modernize and repair the Cooperative Group Program of the NCI. Among the most notable changes are the consolidation of the cooperative groups into the National Clinical Trials Network (NCTN) as well as creation of central IRBs, a common data management system, and molecular characterization laboratories designed to help match targeted therapies to individual patient’s tumors. Despite these advances, there remain significant challenges to clinical research in the community oncology setting. These include regulatory challenges leading to protracted trial activation and conduct (leading to accrual failure), scientific challenges surrounding identification and appropriate triage of subjects based on molecular subtyping to smaller intervention trials, and financial challenges to clinical research imparted by reimbursement reductions and NCI funding constraints. Clearly, these challenges are increasing the difficulty faced by community cancer centers in conducting meaningful clinical research.

The University of Maryland Cancer Network has as one of its core missions to promote cancer clinical trial accrual throughout the cancer programs of the Greenebaum Comprehensive Cancer Center and its affiliated community cancer centers and programs in development. Our goal, as promoted by the NCI is to enroll 10% of our Network’s cancer patients in therapeutic clinical trials over the next five years. This ambitious goal will require significant investment of time and resources by our hospitals, clinicians and staff, and patients. Over the past year we have made significant progress in developing the infrastructure as well as the culture of clinical investigation in our cancer programs. Starting with our first UM Cancer Network Research Retreat in June 2016 (pictured at the left), our organization has devoted significant attention to developing our Network’s clinical trial portfolio across the spectrum of cancers we treat.  In particular, we have stressed the importance of matching trial opportunities to the robust clinical programs at each of our affiliate centers. In most cases, we have emphasized therapeutic trials offered by the National Clinical Trials Network (NCTN), but we also intended to advocate for affiliate participation in investigator-initiated trials developed in the Greenebaum Comprehensive Cancer Center. In the coming months, we will work toward improved communication of trial opportunities, reduced regulatory burden through use of the Maryland IRB, and improved training of clinical investigators and research staff.  During this time, please look for opportunities to open and support clinical trials in your environment.

References:

  1. Keating P, Cambrosio A. Cancer clinical trials: the emergence and development of a new style of practice. Bull Hist Med 2007;81:197-223.
  2. Zon RT, Bruinooge SS, Lyss AP. The changing face of research in community practice. J Oncol Pract 2014;10:155-60.