Re-Evaluating Standard Clinical Trial Practices as a Result of COVID-19

An article published in the Journal of the National Cancer Institute detailed the impact of coronavirus disease 2019 (COVID-19) on clinical trial execution at the Dana-Farber Cancer Institute (DFCI).

Though the threat of COVID-19 is easing, researchers indicated that the situation be used as an opportunity to re-evaluate standard practices for clinical trials in order to make them more accessible and less stressful for potential patients and thus allow for broader participation within clinical trials.

“The continued enrollment to therapeutic clinical trials at DFCI and other cancer centers around the country during COVID-19 demonstrates that cancer clinical research is robust and can be adapted to changing circumstances. Additionally, these changes can be adopted without compromising safety, as seen by a lack of increase in serious adverse events and major violations,” the authors explained. “However, it is prudent to consider the changes that are taking place not only as stopgap measures to respond to a temporary health crisis, but perhaps also as considerations in long-term improvements in clinical trial design to reduce the burden on study participants and research staff.”

Relevant data was retrospectively tracked from oncology clinical trials at DFCI from January 1, 2019 to June 30, 2020, including the number of open trials, new patient enrollments, in-person and virtual patient visits, dispensed investigational infusions, dispensed/shipped oral investigational agents, research biopsies, and blood samples. Researchers also ascertained why patients came off trials and determined on-site clinical research staffing levels.

“Despite the limitations imposed by social distancing requirements, travel restrictions, remote work policies, and limited support staff for correlative studies, DFCI was able to continue enrolling patients onto therapeutic clinical trials at approximately half the pre-COVID-19 rate; moreover, nearly all the patients previously enrolled were able to stay on the studies,” the authors noted. “This continued new enrollment and treatment for existing participants were mostly due to practice modifications that allowed patients to participate remotely as recommended by our state and federal agencies.”

The median number of investigational prescriptions shipped to patients was found to have increased from 0 to 74 (range, 22-107) per week from March to June 2020. Moreover, the median number of telemedicine appointments increased from 0 to 107 (range, 33-267) per week during the same time period.

However, research biopsies and blood collections decreased dramatically after COVID-19-related policies were implemented in March 2020. Additionally, the number of research nurses and clinical research coordinators on-site also decreased after March 2020.

Of note, though substantial changes were required by the facility in order to safely continue research throughout the pandemic, no increases in serious adverse events or major violations related to drug dosing were observed. Further, no complaints specific to the execution of clinical trials under the COVID-19-related restrictions were reported.

Importantly, the experience of DFCI may not reflect the situation encountered at all cancer centers across the country, as policies and resources differed by center. Regardless though, the investigators indicated that these findings point to the need to consider the current changes taking place not only as responses to this temporary health crisis, but also as possible long-term improvements in clinical trial design.

“Many of the modifications made to ensure the safety of patients and staff during COVID-19, including telehealth visits, remote monitoring, and shipping of investigational agents, could benefit cancer patients in general as the pandemic wanes,” the authors wrote. “Frequent traveling to the clinic in particular has been identified as a source of difficulty for cancer patients and a barrier to participation in clinical trials, particularly for ethnic and racial minorities.”

“Reducing the number of required visits 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,” added the authors.

Reference:

Tolaney SM, Lydon CA, Li T, et al. The Impact of COVID-19 on Clinical Trial Execution at the Dana-Farber Cancer Institute. Journal of the National Cancer Institute. doi: 10.1093/jnci/djaa144