- Study details how actions taken at Dana-Farber enabled cancer clinical trials to stay on track during pandemic
- Telemedicine, home delivery of medications, medical compliance, and continued attention to safety allow most patients to remain on trials while staying at home
- Innovations made during pandemic may find a permanent place in cancer clinical research going forward
Even as the COVID-19 pandemic tested the country’s health care system as never before, clinical research in cancer stayed largely on course at many cancer centers. At Dana-Farber Cancer Institute, which adopted alternatives to in-person visits for clinical trial participants as the pandemic surged, researchers have issued a scientific report on lessons learned from the experience. Among their findings: many of the changes made in the heat of crisis have proven so beneficial that they could become a permanent feature of clinical trial design.
The study, published today by the Journal of the National Cancer Institute, recounts how clinical research practices changed at Dana-Farber in response to state and federal policies for limiting the spread of COVID-19, and documents the effect of those changes on trial enrollment and management. Data collected from January 2018, well before the pandemic struck, through June 2020, after the pandemic had abated somewhat, document the stability and safety of clinical research at the Institute at the height of the pandemic.
The data show that not only did almost all patients remain on trials during this period, but new enrollments continued as well. Changes prompted by the pandemic didn’t compromise trial safety: investigators found no increases in serious adverse events among trial participants or major errors in drug dosing.
“Clinical trials provide patients with access to novel and potentially effective therapies and are essential to advancing cancer treatment. Some of these may be the most effective therapies available for specific patients,” says Dana-Farber Chief Clinical Research Officer Bruce Johnson, MD, senior author of the new study. “In planning our response to the COVID-19 pandemic, we made a commitment to continue our clinical trials insofar as possible and maintain patient enrollment. We worked out what we needed to do to make that happen and set up a system of data-collection to track enrollment and other metrics of trial viability. The results of this study demonstrate the success of those efforts.”
Like other hospitals across the country, Dana-Farber adopted an array of policies synced with federal and state guidelines for protecting patients, staff, and visitors from COVID-19 transmission. These included a shift to at-home work for many Institute employees, mandatory mask-wearing in Institute facilities, screening patients and visitors for COVID symptoms, expanding the use of telemedicine for patient visits, and mailing oral investigational medications to patients rather than having them picked up at the Institute pharmacy.
Data show a dramatic increase in telemedicine and home delivery of medications during this period. Investigators found that the median number of investigational prescriptions shipped to patients increased from zero per week in March 2020 to 74 per week in June. The median number of telemedicine visits per week increased from zero to 107 over the same time period.
Some of the changes prompted by the pandemic – particularly the shift to telemedicine, home delivery of oral medications, and clinical laboratory tests at outside facilities for trial participants – represent a departure from standard clinical research protocols. Dana-Farber clinical researchers worked with trial sponsors and government regulators to modify protocols so patients could continue to participate in trials remotely.
In mid-March, Dana-Farber adopted its highest level of COVID-related restrictions, which, among other actions, limited the number of research nurses and clinical trial coordinators working on-site. The monitoring of clinical trials was conducted remotely, and collection of patient tissue for investigational analyses was curtailed during this period. In May, some of these restrictions were lifted, enabling more patients to be seen in-person and tissue collection and analysis to resume.
The restrictions on tissue collection brought a temporary halt to some “correlative” research in which tissue from clinical trial participants is analyzed for biomarkers of the effectiveness of treatment. During the peak months of the pandemic, tissue biopsies were limited to cases in which they had the potential to save lives or alter the course of a patient’s disease.
Even as Dana-Farber succeeded in keeping trials running and patients enrolled, the impact of COVID-19 on clinical research at the Institute was not negligible. Data collected by the study authors show that since COVID-19-related policies were put in place, 49 of the 568 open trials at the Institute were temporarily or permanently closed and 154 were put on hold (often because of reductions in tissue collection). Also, 41 trials approved by Dana-Farber’s Institutional Review Board had not opened as of the end of June.
“The ability of Dana-Farber and other cancer centers to continue enrollment to therapeutic clinical trials during COVID-19 demonstrates that cancer clinical research remains robust and can be adapted to changing circumstances,” Johnson says. “Our experience also shows it can be done without compromising patient safety.
“Innovations such as telemedicine, which enable patients to see their care team without having to travel, were instituted as stopgap measures but could benefit patients in general as the pandemic wanes,” he continues. “Reducing the number of visits required for clinical trials would eliminate unnecessary stress and allow cancer patients to spend more time with their families, potentially increase the ethnic diversity of clinical trial participants, and improve overall quality of life.”
The lead author of the study is Sara M. Tolaney, MD, MPH, of Dana-Farber. Co-authors are Christine A. Lydon, Tianyu Li, MS, Jiale Dai, PhD, RPH, Andrea Standring, PharmD, Kristen A. Legor, JD, RN, OCN, Caryn M. Caparrotta, BSN, RN, OCN, Nabihah Tayob, PhD, Steven G. DuBois, MD, Jeffrey A. Meyerhardt, MD, and Mary-Ellen Taplin, MD, of Dana-Farber; and Matthew P. Schenker, MD, Daniel I. Glazer, MD, of Brigham and Women’s Hospital.
The study was funded by the Steven and Alice Cutler Fund for Clinical Research.