First, applicants should document that the definition of standard of care has been co-developed or vetted by patients and others with lived experiences in the community setting. Moreover, applicants should document equipoise from both an ethical, patient and clinician perspective. Equipoise needs to be addressed in situations in which usual care may be viewed as suboptimal to the comparator intervention. I say this because marginalized populations that may not have access to newer, more expensive therapies may feel compelled to enter a research study because they want to gain access to the novel therapy and can only do so if they participate in a comparative effectiveness research study. Moreover, there may be additional issues related to differential drop out rates when a usual care arm is included. Attrition may need particular attention beyond what is addressed elsewhere in the PCORI Methodology Standards.
C. Daniel Mullins
Researcher, health/medical
Representing my own views