Cancer clinical trials occupy a precious space in the health care system, especially with patients. For many, the trials represent the last chance for a cure or, at least, a staving off, of the relentless and deadly disease.
The trials, though, are often bogged down by redundancies and bureaucratic muck from beginning to end, according to a report issued jointly by the American Society of Clinical Oncology (ASCO) and the Association of American Cancer Institutes (AACI).
They’ve become more challenging to conduct, as they must comply with often costly and inefficient federal and state regulatory requirements, according to researchers from several universities and institutions.
When federal and state governments take notice, it can become like the old E.F. Hutton commercial where everybody freezes. That’s because “institutions and sponsors often interpret these requirements conservatively and thereby add to the complexity and perceived (but often highly theoretical) risk of conducting clinical trials,” the report states.
To find a way to break these logjams, ASCO and AACI launched the Best Practices in Cancer Clinical Trials Initiative. The initiative was overseen by a group of hematologists, oncologists, research nurses, administrators, and managers. The FDA and the National Cancer Institute provided input. A survey of 1,200 stakeholders in the fall of 2015 yielded about 310 usable responses.
The responses pointed to two issues: Getting the trials up and running, and then conducting those trials in a smooth fashion. The top three barriers to getting the trials started were contract negotiations with sponsors, contract negotiations with contract research organizations (CROs), and complying with industry requirements.
The three biggest problems in conducting the trials were site-monitoring visits, managing regulatory documents, and reporting of adverse or serious adverse events.
Among the suggestions for improving the launch of trials were developing master agreements between sites and sponsors to cover agreements that do not vary across trials, a centralized repository of templates and tips for negotiating contracts, and working with stakeholders to create worksheets that identify services that aren’t related to oncology for each trial.
Suggestions for making trials run more smoothly included harmonizing training requirements, deployment of cancer-specific electronic data capture systems, and convening stakeholders to examine why FDA guidelines haven’t been adopted.
Clinical trial sites will often do an insurance coverage analysis to identify routine costs that can be billed to insurers. But the coverage analysis can be a mess that includes many redundancies, according to the ASCO–AACI report: “Coverage analyses are completed by a myriad of research team members with various levels of knowledge, skill, and expertise in the arena of clinical trials coding and billing.” The report suggests developing a Turbo Tax–type app that would let sites conduct coverage analyses quickly. It also suggests writing guidelines that would delineate the boundary between routine care and research.
ASCO and AACI plan to expand the effort, focusing on adverse event reporting, site qualification, and insurance coverage analysis.