Centralization in clinical trials
ALEXANDRIA, Va. & ROCKVILLE, Md.—The American Society of Clinical Oncology (ASCO) has collaborated with the National Cancer Institute (NCI) to explore the benefits of centralizing the development of coverage analyses for multisite cancer clinical trials.
Clinical trial billing compliance is a challenge that is faced by overburdened clinical trials sites. The requirements place institutions and research sites at increased potential for financial risk. To reduce their risk, sites develop a coverage analysis (CA) before opening each trial. For multisite trials, this translates into system-wide redundancies, inconsistencies, trial delays and potential costs to sites and patients, factors that exacerbate low accrual rates to cancer clinical trials.
In an effort to reduce the burden of clinical trial billing, an ASCO Research Community Forum working group proposed the concept of providing centrally developed CAs to research sites at protocol startup. The group collaborated with NCI to hold a one-and-a-half-day symposium for key stakeholders to share knowledge, build skills, provide tools to conduct centralized CAs and strategize about the next steps needed to move forward with developing such a system.
Following the symposium, ASCO published an article in the Journal of Oncology Practice, “Feasibility of a Centralized Clinical Trials Coverage Analysis: A Joint Initiative of the American Society of Clinical Oncology and the National Cancer Institute,” in which the authors assert that developing a centralized system for coverage analysis is a feasible way to address key issues and reduce administrative burdens for cancer research sites managing billing compliance, with potential for widespread benefits across the cancer research field.
“Centralization of coverage analysis will help sites by reducing redundancies and ambiguity and streamlining billing processes by increasing efficiencies and improving accuracy, all of which helps save time and costs,” asserts Connie Szczepanek, lead author of the article and chair of the ASCO Research Community Forum Insurance Coverage Working Group. “This is especially important in cancer care, which is complex and can be very expensive. Ultimately, this serves to improve patient care, allowing care providers to spend more time with patients and increasing the opportunity for patients to participate in clinical trials.”
A pre-symposium survey was conducted to gauge needs, impact and barriers related to CA and billing compliance. The findings were used to develop a working agenda, targeted materials and presentations, and to anticipate working groups that may be required to move the goals forward.
Nearly 50 staff from NCI research sites and cooperative groups, including the NCI National Clinical Trials Network (NCTN) and NCI Community Oncology Research Program (NCORP) Research Bases, attended the symposium. The attendees concluded that centralized CAs for multisite trials—using standardized tools and templates—are not only feasible, but have the potential to reduce risk for patients and sites, forecast budget needs and help decrease trial startup times that impede patient access and accrual to clinical trials.
“Establishing a centralized system that provides coverage analysis to research sites participating in a multisite cancer clinical trial before trial launch would reduce system-wide redundancies and costs, as well as time and resource burdens on sites,” said Dr. Dax Kurbegov, chair-elect of the ASCO Research Community Forum Council and contributing author for the article. “By improving efficiencies and billing compliance consistency and accuracy, centralizing coverage analysis development has the potential to increase patient accrual and site participation for multisite cancer clinical trials.”
Szczepanek noted that this stage of the project was focused on convening groups that conduct cancer clinical trials, to explore how to streamline processes regarding protocol development and implementation, with the end goal of helping to reduce administrative burden for those on the front-line of conducting clinical studies. “The collaboration also included an active dialog with Centers for Medicare & Medicaid Services, with a representative attending the symposium, to establish standardized practices that we believe will address the needs of public and private payers,” she said.
As a follow-up to the symposium, centralized CAs for multisite trials, using shared learning and standardized tools and templates, are being pilot tested across NCTN groups and NCORP research bases. According to Szczepanek, an NCI-CTSU pilot project was developed and is underway to test the feasibility and utility of national coverage analyses for NCI trials.
“Early indications are favorable that centralizing development of CAs for protocols as they’re released has helped to reduce administrative burden on participating NCI trial sites,” she says. In addition, the forum will be hosting a training workshop to provide research sites with skills and resources needed for better understanding the process of assessing insurance coverage for clinical trials, potential barriers, and preventing and addressing insurance denials.
The authors of the study emphasize the urgency of fostering such collaboration. “In this challenging era of increasing regulatory and compliance demands faced by sites that conduct clinical trials, it is imperative to foster collaborations across multiple stakeholders—including sponsoring agencies, companies and sites—to address challenges and barriers to participation. Efforts to centralize CAs have the potential to improve cost-effectiveness and efficiencies for all clinical trials, including federally led, industry-led and investigator-led trials. More efforts are needed to promote this centralized approach to industry-sponsored trials so that the potential benefit for the management and conduct of these clinical trials is realized.”