Evaluation of a Global Item for Side Effect Bother

This project aims to evaluate the measurement characteristics for an existing patient-reported global item to quantify overall side effect impact for patients receiving treatment for cancer. Specifically, this project aims to assess the association of such a global item, the FACIT GP5, with 1) attributes of physical and role function, 2) patient-reported symptoms associated with treatment, and 3) clinician-reported symptomatic AEs that are anticipated to be bothersome to patients. The project will leverage existing trial data that can be accessed through databases (Vivli, Project YODA) and cooperative trials groups (ECOG-ACRIN). The project aligns well with “Harness Diverse Data through Information Sciences to Improve Health Outcomes.” The 2011 strategic plan for Advancing Regulatory Science at FDA lists eight science priority areas. The area “Harness Diverse Data through Information Sciences to Improve Health Outcomes” highlights that analyzing data from a range of sources is critical for FDA, given the volume of data received as part of its regulatory mission. Consideration of all evidence is an important aspect of regulatory risk-benefit assessments. In oncology specifically, the Oncology Center of Excellence (OCE) Scientific Collaborative has identified nine areas of scientific interest for applied research. Patient-focused drug development in oncology is one such area (OCE scientific area IV), and OCE’s interests focus on methodological and assessment approaches for evaluating the patient experience. The proposed project specifically aligns with OCE’s area of scientific interest 5.7.1, “Investigate measurement characteristics for new and existing patient-reported global items quantifying overall side effect impact such as the FACIT GP5 item for patients undergoing anti-cancer therapy.” This area is linked to Objective 5 from the plan, the aforementioned “Harness Diverse Data through Information Sciences to Improve Health Outcomes.”