The effect of the COVID-19 pandemic on oncology clinical trials could lead to changes in how these trials are conducted even after the crisis ends, according to the findings of a survey of clinical trial programs in the United States by the American Society of Clinical Oncology.
“Numerous challenges with conducting clinical trials were reported, including enrollment and protocol adherence difficulties with decreased patient visits, staffing constraints, and limited availability of ancillary services,” David M. Waterhouse, MD, MPH, of Oncology Hematology Care in Cincinnati, Ohio, and collaborators wrote in JCO Oncology Practice.
The investigators based their findings on 32 survey respondents representing 14 academic and 18 community-based clinical trial programs. “Although the survey reflects a small sample of research programs in the United States during a rapidly changing situation, the results provide insight into the state of clinical trials across a range of types of research programs in the early weeks of the COVID-19 pandemic,” the investigators wrote.
More than half of respondents said they observed a decrease in patient ability or willingness to come to their site, and cited the staff time needed to organize, implement, and conduct telehealth visits as a significant challenge. Results showed that 90% of respondents identified telehealth visits for participants as a potential improvement in the conducting of a clinical trial, and 77.4% indicated that remote patient review of symptoms held similar potential, according to the authors.
“One of the early lessons has been that it is possible to conduct more streamlined or pragmatic trials,” Dr Waterhouse and his coauthors wrote. “Many trials currently include tests, procedures, and strict data collection requirements and windows for assessment that are intended to maximize knowledge gained but may prove burdensome to both patients and trial programs.”
Another lesson, they noted, is that trials could routinely leverage technology to limit in-person visits for trial programs and patients. Many visits by industry sponsors and contract research organizations are being conducted remotely, or in some cases, eliminated altogether, according to the report.
“Given that trial activity is able to continue, many of these in-person visits should not be required post-COVID-19,” according to the report.
Other opportunities to improve clinical trials, according to survey respondents, include shipping oral drugs directly to patients, remote adverse event assessments, and patient review of symptoms as well as streamlined data collection, including decreased collection of “unnecessary data.”
“Increased remote work by research staff was noted as an opportunity to improve job productivity, satisfaction, and staff retention, as well as mitigate space issues at sites.”
Waterhouse DM, Harvey RD, Hurley P, et al. Early impact of COVID-19 on the conduct of oncology clinical trials and long-term opportunities for transformation: Findings from an American Society of Clinical Oncology survey [published online May 13, 2020]. JCO Oncol Pract. doi: 10.1200/OP.20.00275