Urgent action is needed to overcome barriers in clinical cancer research, according to a virtual summit convened by the Society for Immunotherapy of Cancer (SITC).1
The summit brought multidisciplinary stakeholders in cancer research together to identify and consider how to address administrative, staffing, and other barriers that impede progress. Many of the barriers identified existed before the COVID-19 pandemic but have become more challenging as the pandemic wears on.
Mary Dean, JD, SITC’s executive director, cited an unpublished survey of 44 National Cancer Institute-designated cancer centers, which showed that clinical trial accrual decreased 20% from January 2020 to February 2022. The survey also showed that “personnel issues” plagued 95% of the cancer research offices.
These challenges are superimposed on concerns about rising administrative burdens and issues related to the business models on which clinical research in the United States are structured, Dean said. These issues come at a time when immuno-oncology research dominates all phases of clinical cancer research, she added.2 As a result, the impact is particularly relevant for SITC’s 4300 members.
“It’s imperative … that we find workable solutions to the current challenges we face,” said SITC Vice-President Leisha Emens, MD, PhD, of the UPMC Hillman Cancer Center in Pittsburgh, Pennsylvania. “If we don’t, it will set the science back years while our patients still count on us to keep moving forward.”
Defining the Problem
Recent therapeutic successes have imposed new strains on the research ecosystem, said Mario Sznol, MD, an oncologist at Yale Cancer Center in New Haven, Connecticut, a past SITC president, and a member of the summit’s leadership group.
Dr Sznol said that investigation of complex treatments (such as cellular therapies) results in a lower ratio of research staff to patients. More effective therapies produce longer times on study treatment, lengthier follow-up, and extended periods of data collection.
In addition, because the outcomes of targeted therapy combinations are difficult to predict, studies are designed with complex biomarker and pharmacodynamic measurements. Interdepartmental coordination for tissue acquisition and processing requires additional effort and communication as well.
SITC organized the virtual summit with these issues in mind. SITC asked 4 multidisciplinary panels of thought leaders to consider ways to streamline processes and adapt to an environment in which there are fewer staff members in clinical research programs.
Streamlining Data Collection and Entry
A panel chaired by Stephanie Terzulli, PhD, vice-president for clinical research operations at Memorial Sloan Kettering Cancer Center in New York, New York, focused on mechanisms for making data collection and entry less laborious while maintaining data integrity. Dr Terzulli summarized the panel’s discussions and suggestions.
The panel acknowledged that manual data entry is inefficient, that electronic data capture is laborious, and that both are error prone.
Each data element is subject to queries, resulting in delays in interim analyses and study completion. Although all parties want studies to yield the maximal amount of accurate, scientifically important information, the required tasks can be duplicative, costly, and especially frustrating when there are staff shortages.
A plethora of electronic data capture systems and electronic health records demand individualized training and certification of staff. These requirements accentuate the effects of unfilled research staff positions and make trials costly to launch and conduct.
The panelists concluded that potential solutions should involve developing standardized, structured data that would be acceptable to sites, sponsors, and the US Food and Drug Administration.
Direct data transfer from electronic health records, including information on the patient experience from patient-reported outcome tools, could be pilot-tested in investigator-initiated trials and later expanded to other trial types. Natural language processing and artificial intelligence could automate some elements of data acquisition and transmission.
The panelists agreed that technology-associated costs and the initial effort to develop standardized data elements across sponsors would be modest when measured against the costs of staff turnover and training.