Dr. Meredith K. Chuk
Dr. Francis J. Giles
Session Chair Julie M. Vose, MD, MBA, FASCO, of the University of Nebraska Medical Center and past ASCO president, said the session will outline the most pressing issues relating to the administrative and regulatory requirements for the conduct of clinical trials, as identified by relevant stakeholders. The session will also address practical ways to streamline some of these processes for more efficient trial conduct while maintaining patient safety, with a focus on highlighting problems common to many centers conducting clinical trials and offering solutions to improve overall effectiveness.
“Overburdensome regulation and administrative issues like duplicative processes slow the ability of getting patients to treatment,” Dr. Vose said.
Dr. Vose will discuss the challenges of opening and enrolling patients in clinical trials. Other session presenters will include Meredith K. Chuk, MD, of the U.S. Food and Drug Administration (FDA), who will discuss the FDA perspective on safety reporting of serious adverse events, and Francis J. Giles, MD, of Northwestern University, who will present practical approaches to reducing the administrative burden of clinical trials.
During her tenure as ASCO president, Dr. Vose directed an ASCO survey of centers conducting cancer clinical trials, with an emphasis on exploring issues that impeded the goal of clinical trials to deliver effective, safe medications to patients with cancer. “We had about 400 responses to the survey and found that many problems were the same,” she said. “Federal and state regulatory and legal issues lead to inefficiencies, but so do overly conservative or repetitive practices at the clinical trial centers themselves.”
The results of that survey, along with specific recommendations, were published in the Journal of Clinical Oncology in November 2016.1 Dr. Vose will discuss these findings at the session.
Communication and Standardization
“There are a lot of big, exciting things happening in cancer [care and research],” Dr. Giles said. “But I think we oncologists can all agree that the percentage of patients going on clinical trials is deplorably poor.”
Dr. Giles will be discussing what organizations can do to make clinical research more accessible and effective. “One of the major problems is unnecessary duplication,” he said, where many pharmaceutical companies and clinical research organizations provide multiple points of contact on research conduct with a single institution. In his talk, Dr. Giles will offer suggestions to reduce those multiple points by implementation of common policies.
“We have a fragmented intake now, where there is major room for improved communication, cohesion, and standardization across the major cancer centers,” he said. “Standardized budgets, standardized processes to decide if the study will be opened or not, and standardized relationships with pharmaceutical companies and clinical research organizations are also worth pursuing.” Dr. Giles also suggested developing standardized job descriptions for research colleagues involved in clinical trials and reasonable metrics for performance and efficiency.
“The current chaos is not inevitable,” Dr. Giles said. “It is a choice that needs to change for the sake of our patients, our colleagues, and our staff. We can choose to behave as a community to address some of the obvious challenges and, thus, increase patient participation in clinical studies and reduce the hemorrhage of morale, effort, and resources.”
New Drug Safety Reporting
Dr. Chuk will offer the FDA perspective on expedited investigational new drug (IND) safety reporting, providing an understanding of the applicable federal regulations and FDA guidance.
“An analysis2 conducted by the FDA’s Office of Hematology and Oncology Products showed that the majority of expedited IND safety reports submitted to the FDA are uninformative,” Dr. Chuk said. “This can obscure true safety signals and strain the limited resources of the FDA.” Dr. Chuk will discuss FDA initiatives for electronic safety reporting designed to streamline the safety reporting process.
“Understanding of and adherence to existing federal regulations on IND safety reporting can drastically reduce the number of uninformative safety reports and actually enhance patient safety with earlier and more efficient identification of relevant safety signals,” she said.•
*Program information updated as of May 15. For session time and location information, please refer to the ASCO iPlanner on the Attendee Resource Center