PATIENT-REPORTED OUTCOMES (PROS) IN OVARIAN CANCER CLINICAL TRIALS
Author(s)
Pease S, Barsdorf AI
Pfizer, New York, NY, USA
Presentation Documents
OBJECTIVES: To assess use of Patient-Reported Outcomes (PROs) in studies of Ovarian Cancer. METHODS: A search of Citeline’s Trialtrove was conducted using the search criteria of “Ovarian Cancer” as the disease, drugs tested was “any,” and trial phase was II/III, III, and IV. This resulted in 252 trials. Studies were excluded if the disease type was other than ovarian cancer. Study designs were clinical trial and observational studies, and both double-blind and open-label studies were included. Target accrual for all studies was ≥53. Start dates ranged from 1990 to 2014. The remaining 189 trials were then assessed for prevalence and type of PROs. RESULTS: Of the 189 studies reviewed, 102 (54%) included PROs. For these 102 trials, a total of 148 PROs were included, and an average of 1.5 PROs were used per study with a range of 1 to 4. A total of 15 different PROs were identified. One hundred twenty-six (85%) of these PROs measured Health-Related Quality of Life (HRQL), 10 (7%) measured QoL/Utilities, 9 (6%) measured Symptoms, 2 (1%) measured Activities of Daily Living and 1 (1%) was categorized as other. Within the HRQL measures, 35 (28%) were ovarian cancer specific measures, 27 (21%) were cancer general measures, 6 (5%) were cancer treatment specific, 2 (2%) were generic measures and 1 (1%) was chemotherapy treatment specific. The remaining 55 (43%) HRQL endpoints were unspecified. CONCLUSIONS: PROs are included in ovarian cancer clinical studies approximately half the time, which is low compared to other disease areas. The majority of measures assess HRQL and are specific to ovarian cancer. Including HRQL in ovarian cancer studies can support the value of progression free survival to patients. PROs can be used to show the value of new ovarian cancer drug therapies.
Conference/Value in Health Info
2015-05, ISPOR 2015, Philadelphia, PA, USA
Value in Health, Vol. 18, No. 3 (May 2015)
Code
PCN122
Topic
Patient-Centered Research
Topic Subcategory
Patient-reported Outcomes & Quality of Life Outcomes
Disease
Oncology