To improve clinical trial availability, effectiveness, and diversity in the era of the COVID-19 coronavirus, National Cancer Institute (NCI)-funded clinical trials should adjust their design to increase use of telemedicine and remote informed consent, among other strategies, several NCI department leaders wrote in a commentary in the Journal of the National Cancer Institute.
The pandemic and its socioeconomic ramifications have led to “a substantial, immediate-term decrease in accrual to both diagnostic and therapeutic cancer investigations as well as substantive alterations in patterns of oncologic care,” the leaders said. But it creates an opportunity to make changes to clinical trial designs that benefit society long after the pandemic.
Leaders from NCI’s Cancer Therapy Evaluation Program, Center for Cancer Research, Community Oncology Research Program, Coordinating Center for Clinical Trials, and Division of Cancer Treatment and Diagnosis recommended the following strategies:
- Use telemedicine to enhance patient access.
- Improve data integration into electronic health records.
- Simplify statistical designs.
- Minimize and expedite the review process, particularly for rare cancers.
- Adjust personnel requirements and use electronic auditing.
- Work with the U.S. Food and Drug Administration to simplify the regulatory framework.
- Minimize the need for nonessential tests.
- Use electronic consent forms that can be completed remotely.
“At the crossroads of cancer, COVID-19, and growing social inequities, substantive opportunities to improve the current methodology of oncologic clinical investigation have manifested themselves in dramatic fashion,” the leaders wrote. “Now is the time to make fundamental changes that will lead to sustainable improvements in our approach to and conduct of clinical cancer research, changes that will provide broad, long-lasting benefit to all patients and to society.”
Learn more about NCI’s plans for cancer clinical trials during COVID-19 in an interview with NCI Director Ned Sharpless, MD, on the Oncology Nursing Podcast.