Some Clinical Trials Changes due to COVID-19 Proposed for Long-term Use by NCI Leaders

Date Posted

In a commentary written by several of its clinical scientific leaders, changes were proposed to the National Cancer Institute (NCI) clinical trials program to improve clinical trial availability, effectiveness, and diversity.

The article, “COVID-19, Social Justice, and Clinical Cancer Research,” in the Oct. 15, 2020, issue of the Journal of the National Cancer Institute, suggests there is a growing consensus that the regulatory and clinical research process alterations that have been adopted in response to the COVID-19 pandemic should be implemented long term. These include the use of telemedicine visits to reduce patient travel requirements and the application of remote informed consent procedures.

The commentary was written by James Doroshow, M.D., Deputy Director, Clinical and Translational Research, Division of Cancer Treatment and Diagnosis (DCTD) and Center for Cancer Research (CCR); Sheila Prindiville, M.D., director of the Coordinating Center for Clinical Trials (CCCT); Worta McCaskill-Stevens, M.D., director of the NCI Community Oncology Research Program (NCORP); and Margaret Mooney, M.D., associate director, Cancer Therapy Evaluation Program (CTEP). Patrick J Loehrer, M.D., Indiana University Melvin and Bren Simon Comprehensive Cancer Center, is also an author.

They noted that the COVID-19 pandemic and related socioeconomic events changed the environment in which cancer clinical trials are conducted, resulting in “a substantial, immediate-term decrease in accrual to both diagnostic and therapeutic cancer investigations as well as substantive alterations in patterns of oncologic care.”

Yet, major practice changes have been embraced nationwide as clinical trials sponsors, including NCI and cancer centers, and community oncology practices that conduct trials have adapted models of care, use of health care personnel, and regulatory requirements to continue cancer investigations while maintaining high levels of patient safety during the public health emergency. It has also refocused the cancer clinical trials community on the need to bring clinical trials closer to patients by “dramatically enhancing” access, especially for minority and underserved communities that have been disproportionately affected by the pandemic.