In a recent video interview with Urology Times about the BCG vs gemcitabine/docetaxel (gem/doce) bridge trial, Angela B. Smith, MD, MS, vice chair of Academic Affairs and professor of urology at the University of North Carolina School of Medicine in Chapel Hill, underscored the essential role of patient-reported outcomes (PROs) in bladder cancer research.
Smith noted that the trial, led by Max Kates, MD, and supported by a dedicated PRO committee, demonstrates how integrating patient perspectives strengthens clinical evidence. Traditional end points such as recurrence and survival, she explained, often overlook critical information about the patient experience—insights that can influence whether a treatment is accepted or rejected in real-world settings. Including PROs, she said, provides the “full story” by capturing how patients perceive treatment burdens, trade-offs, and quality-of-life effects that ultimately impact adherence and implementation.
Smith emphasized that balancing PROs with conventional clinical end points requires involving patients early in trial design. Patient advocates can help identify which outcomes matter most and ensure PRO measures are appropriately designated as primary or secondary endpoints.
She pointed out that PROs are too often added late in the process, which weakens their impact. Simply engaging patients at the outset, she said, requires little extra effort yet substantially improves both scientific rigor and patient relevance.
On funding, Smith explained that adding PROs to an existing clinical trial typically involves only a modest additional cost. For studies focused primarily on PROs, she highlighted the Patient-Centered Outcomes Research Institute (PCORI) as a valuable resource, citing its support for engagement awards, comparative effectiveness research, and dissemination and implementation studies. She added that industry partners are increasingly recognizing the benefits of patient engagement and are now more willing to support PRO integration, including funding patient advocate participation in study design. Taken together, these approaches make PRO-driven research more achievable and help ensure bladder cancer trials capture outcomes that genuinely matter to patients.
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