Spectrum Researcher Addresses COVID-19 Trial Prioritization Issues

Early in the pandemic, Dr. David Magnus, Director of Stanford’s Center for Biomedical Ethics, and Dr. Angela Rogers spoke with Spectrum’s Director and PI, Stanford School of Medicine’s Senior Associate Dean of Research, Dr. Ruth O’Hara, about creating a task force to make decisions about which COVID-19 clinical trials should be prioritized. Dr. Magnus was on the COVID-19 ICU task force, and intensivists such as Dr. Rogers were already being inundated by requests to enroll their patients in clinical trials. It was clear that coordination would be needed to choose which trials should be prioritized. Dr. O’Hara launched a committee, chaired by Stanford’s Dr. Ken Mahaffey and Dr. Upi Singh, to review research requests and establish a process by which all COVID-19-related human subjects research would be reviewed. This included creating an interventional trial sub-committee chaired by Dr. Steve Goodman.

“Fairly early in that process, it was clear that this was (at least initially) a pretty significant challenge that we were facing, as everyone wanted to contribute to fighting the pandemic and there just weren’t enough patients to meet all the enrollment requests for the trials,” explains Dr. Magnus. “As I was thinking about our experience at Stanford, I was attending a Zoom meeting with other folks in research ethics, and felt like the folks at Michigan were experiencing similar challenges and were ahead of us in thinking about the issues involved.”

…intensivitsts such as Dr. Rogers were already being inundated by requests to enroll their patients in clinical trials. It was clear that coordination would be needed to choose which trials should be prioritized.

Dr. Magnus reached out to Kayte Spector-Bagdady, Chief of the Research Ethics Service in the Center for Bioethics and Social Sciences in Medicine (CBSSM) at the University of Michigan, to discuss whether it would make sense to get a group together to compare notes and develop best practices, and to publish some recommendations based on our collective experiences. She agreed, and shortly thereafter they reached out to research ethicists involved in these and other COVID-related research ethics issues. They wound up organizing a group with representatives from Stanford and Michigan, Harvard, Penn, Mayo, Geisinger, Johns Hopkins, NIH’s ethics center, Indiana University, and Seattle Children’s Hospital/University of Washington.

From there the group met and discussed the approaches being taken to both the issue of research prioritization and how to allocate patients to particular trials. Those who had time volunteered to take the lead in writing papers, and the group collectively began making comments on drafts and sharing experiences. The group’s first paper was published in Clinical Trials on research prioritization. First author was Michelle Meyer from Geisinger.

https://journals.sagepub.com/doi/full/10.1177/1740774520988669

“One of the difficulties in deciding how to prioritize research is the trade-off between making small contributions to large, well-designed, randomized trials that are not driven by Stanford, versus earlier phase trials that are unique to Stanford but farther from development,” explains Dr. Magnus. “This paper argues for a portfolio approach that has guardrails to ensure that bad research does not drive out better designed research, but recognizes multiple dimensions of a robust, diverse, research portfolio.”

The second paper, currently under revision, “explores how hospital systems designing COVID-19 treatment trails can ensure that scarce trial opportunities are fairly allocated among diverse communities” Professor Spector explained. She added that “being able to work in conjunction with colleagues, such as Dr. Magnus, across the country allowed us to ensure that we were offering best practices for equitable trial and participant prioritization.”