The cancer research community needs to filter out wasteful clinical trials and encourage research that challenges unproven practices that consume resources, three Canadian researchers argue in an opinion piece published today in JAMA Oncology about cancer research after COVID-19.
The viewpoint, titled “The Day After COVID-19 — Time to Rethink Oncology Clinical Research,” argues for a more selective approach to research that will is more likely to yield meaningful results while also husbanding resources.
Daniel Araujo, M.D., Geoffrey A. Watson, M.D., and Lillian L. Siu, M.D., all of the Princess Margaret Cancer Centre in Toronto, also discuss the possibility of a greater reliance on telemedicine, virtual tumor boards, and centralized artificial intelligence facilitating “the search for suitable clinical trials.”
“Clinical research must be leaner and more efficient,” they write. “It is time to incorporate new technologies, revisit old practices and move forward toward better outcomes for our patients.:
Here are some of the points they made:
- “The message from the pandemic wake-up calls is clear — our society can no longer accept incremental clinical trials.” Araujo, Watson and Siu say the scientific community must share its collective to “raise the bar” to conduct trials that have the greatest chance to produce meaningful results.
- They endorse adaptive trial design as making drug development more agile and possibly leading to novel treatments sooner.
- They caution against replacing overall survival and quality of life with unvalidated surrogate end points.
- Research that examines “value-unproven practices” should be encouraged. They cite as an example the evaluation of the optimal duration of immune checkpoint blockade among durable responders,
- Investigation of me-too drugs or drug combinations should be discouraged unless there is a “clear path” to improved therapeutic index.
- “Interminable wet-ink signature” requirements on trial documents should be replaced with digital signatures, and duplicate requests by different sponsors should be managed through an online database.
- “The value of serial physical examinations in asymptomatic patients is the subject of scrutiny.”Araujo, Watson and Siu caution against compromising care, nothing that physical examination remains a crucial assessment tool. “Nonetheless, for most cases, a telemedicine appointment with blood tests collected in local laboratories may suffice.”
- Exclusion criteria should be reconsidered. They cite as an example the exclusion of patients living with HIV with undetectable viral loads from immuno-oncology trials.