August 18, 2022
3 min read
Society for Immunotherapy of Cancer. Crisis in Clinical Research Virtual Summit. Aug. 17, 2022.
Emens reports no relevant financial disclosures.
Clinical trial accrual rates have dropped 20% since the start of the COVID-19 pandemic, poll results showed.
Standardization of data, data collection and processes across sites could be one way to address the crisis in clinical research.
Success for the field of immuno-oncology will require implementing many action points to create a streamlined clinical trial process that requires fewer personnel to conduct.
Staffing challenges have contributed to a “crisis” in new clinical research, with 95% of cancer centers reporting personnel issues resulting from the “great resignation,” according to Society for Immunotherapy of Cancer.
Organization officials said a poll of 44 NCI-designated cancer centers showed clinical trial accrual rates down 20% from January 2020 levels.
With a focus on the impact of the staffing shortage on development of new cancer therapeutics, the Society for Immunotherapy of Cancer (SITC) conducted a virtual summit to identify the scope of the crisis and offer practical solutions to fix the system.
Impediments to the timely and successful conduct of oncology clinical trials are the result of three converging forces, according to summit co-chair Leisha A. Emens, MD, PhD, SITC vice president, professor of medicine in hematology and oncology at University of Pittsburgh School of Medicine, and co-leader of UPMC Hillman Cancer Center’s cancer immunology and immunotherapy program.
First, Emens noted that ongoing staffing issues have been affecting not only clinical trials at academic medical centers but also all stakeholders in the development of cancer therapies — including contract research organizations and trial sponsors.
Emens called the current labor market “challenging” and said academic centers looking to conduct trials are seeing staff leave for more lucrative opportunities in the private sector that offer benefits to promote a more equitable work-life balance.
Finally, Emens said the field of cancer therapy has been victimized by its previous successes.
“Part of what has made clinical trials more challenging is the terrific progress we’ve made with drugs in terms of harnessing key biological pathways that can be targeted for better therapies,” Emens told Healio. “[This] has made clinical trials more complex, which translates into more complex regulatory processes, more complex protocols and an increasing volume of work.”
Doing more with less
Emens said the COVID-19 pandemic accelerated the ongoing staffing deficit to what is now “a critical breaking point.” The SITC’s Crisis in Clinical Research Virtual Summit aimed to develop solutions and help keep the cancer research pipeline moving, she added.
“We need to address how to streamline things so that we can maximize the ability of the available workforce to get the work we need done to make better drugs for patients,” she told Healio.
The summit convened four panels tasked with developing ideas to combat emerging threats to clinical research and the trial process, including inadequate staffing, inefficiencies and increasing costs. The panels included areas on:
streamlining data collection and data entry;
reducing the burden of scientific review and maximizing efficiency in meeting regulatory requirements;
increasing efficiency in study activation and conduct; and
changing the clinical trial business model.
Potential solutions the panels proposed included standardization of data, data collection and processes across sites; centralized institutional and scientific review; efforts to bring trials closer to a greater number and more diverse group of patients; and workforce development with new benefits, including performance-based pay linked to trial accrual.
SITC said it plans to develop a publication that will synthesize the challenges and solutions identified during the summit and will discuss next steps toward implementing solutions with relevant stakeholders, including representatives of the NCI, FDA and industry sponsors.
Emens said continued success for the field of immuno-oncology will require implementation of many of these action points to create a streamlined clinical trial process that requires fewer personnel to conduct.
“In terms of science and the patient, oncology has really led the way in identifying key pathways that can be targeted therapeutically to improve clinical outcomes for patients,” she said.
“We are now at the best time in history to improve clinical outcomes for patients everywhere,” she added. “If we can’t solve this crisis, then it is going to limit our ability to deliver these advances to patients with cancer.”