Unique Challenges for IRBs Evaluating Radiation Oncology Study Protocols
June 1, 2022 3 minutes read
There may be few if any radiation oncology investigators at some institutions, and radiation therapy involves rapidly advancing technology. In light of this, IRBs might lack the necessary expertise to review these studies. “Evidence-based options for radiation therapy delivery techniques and fractionation schedules have proliferated over the past decade,” says Timothy Showalter, MPH, MD, a clinical researcher and professor at the University of Virginia.
IRBs are asked to evaluate clinical trials that investigate specific technologies compared to standard methods. To help IRBs, Showalter and colleagues developed a resource for evaluating clinical trial protocols that involve radiation therapy.1 “In our experience, we observed delays during the review and approval process for many radiation oncology clinical trials,” Showalter says.
Delays were happening because IRBs lacked understanding of basic principles of radiation therapy that affected trial design. “For example, a reviewer may not be familiar with the longer time horizons for the occurrence of adverse events from radiation therapy,” Showalter offers.
This is an important point for IRBs to remember. “Radiation therapy causes an expected range of mild to moderate acute toxicities that generally resolve with time,” Showalter notes.
However, the major focus for radiation therapy technologies and therapeutic advances is on reducing the occurrence of late toxicities after radiation therapy, which can take months to years to develop. IRB reviewers who are unfamiliar with radiation therapy may request multiple follow-up visits within the first month of a radiation therapy course, since this is common for chemotherapy trials. Radiation oncologists often schedule first follow-up visits months after treatment, and late toxicities occur more than three months after radiation therapy. Thus, says Showalter, “an IRB reviewer’s insistence on shorter-interval follow-up is not medically indicated — and may create barriers to clinical trial administration and patient enrollment.”
Showalter and colleagues provided IRB members with a quick resource for basic insights on radiation oncology. “We hope this will streamline clinical trial reviews,” Showalter says.
According to the paper, IRBs frequently ask these questions: How does the trial differ from standard of care? What are other choices if the patient chooses not to participate in the trial? What will investigators do if a new isotope becomes available? Is the timing of the first follow-up with patients after radiation therapy safe? Is there value in collecting information on adverse events years after radiation therapy? Is there a way to assess effects during radiation therapy without requiring patients to make extra visits? Why are routine labs not checked before starting radiation therapy?
“By providing reviewers with information about radiation oncology principles, well-designed radiation therapy trials can proceed more quickly to IRB approval and activation,” Showalter says.
IRBs should consider involving a radiation oncologist when reviewing these studies, suggests Jason Hearn, MD, an associate professor of radiation oncology at the University of Michigan and member of the IRB for radiation oncology at Michigan Medicine. Hearn says IRBs should be asking if the radiation techniques are appropriate. If not, is there anything that could be changed to improve safety and/or efficacy?
“Radiation therapy is a very technical field and physicians outside the field have little exposure to it. It is a ‘black box’ in that sense,” Hearn says.
REFERENCE
- Qazi J, DeHaai KA, Hawkins BM, et al. Demystifying radiation oncology clinical trial concerns for protocol scientific review and institutional review board committee members. Contemp Clin Trials Commun 2022;27:100911.
There may be few if any radiation oncology investigators at some institutions, and radiation therapy involves rapidly advancing technology. In light of this, IRBs might lack the necessary expertise to review these studies.
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