Summary
Postmarketing commitments/requirements (PMR) are common in oncology, especially with accelerated approvals, however, to obtain fit-for-purpose data, prospective designs are often needed. Prospective real-world studies (PrwS), designed to leverage a combination of routinely collected clinical data and intentionally captured data, can improve the efficiency of PMR fulfillment using established patient cohorts and existing infrastructures.
This study aimed to assess the opportunity for PrwS to fulfill oncology PMR within the US regulatory environment. The analysis found that many oncology PMRs due within the past four years are not yet fulfilled, possibly due to delays during site selection, site activation and/or patient enrollment.
When feasible, real world studies can accelerate completion of these important obligations via partnerships between regulators, sponsors, and organizations/networks capable of efficiently executing PrwS. Opportunities for acceleration and/or efficiency with PrwS include site selection/activation, patient identification, and streamlining data collection through an EHR.
Why this matters
PrwS typically require less cost and burden relative to traditional clinical research methods. They are designed to intentionally collect new data on top of existing RWD to be more detailed, specific, and aligned directly to the study’s objectives. This research shows that PrwS are a feasible addition to traditional clinical research methods, opening doors to accelerated, more efficient research while potentially lowering the cost of studies and enabling increased participation from sites and patients.