Health care researchers are increasingly endeavoring to incorporate data in clinical trials that demonstrate a health benefit for patients. One of the measurements that can capture this vital information is health-state utility, which reflects a patient’s rating of their current well-being compared to a “perfect” health state. As such, health-state utility data provide a measurement of quality-of-life, which is part of a long-term calculation of treatment benefit. Health-state utility data are important inputs in cost-utility models that are used in many countries to establish whether the cost of a new intervention can be justified in terms of health benefits. Collection of health state utility data within the clinical trial offers a unique opportunity to directly capture key aspects of treatment benefit; however, careful planning is needed to ensure that these important measures are incorporated in the design of the clinical trial to collect high-quality data for economic models.
The Task Force identified five areas of guidance that will enable researchers to design an optimum utility measurement program within clinical studies. The guidance focused on these specific areas: 1) Early planning of health utility data collection within the research and development program2) Design of health utility data collection during protocol development for a planned clinical trial3) Design of prospective and cross-sectional observational studies for estimating health utility4) Use of alternative study types for health-state utility estimation5) Statistical analyses and reporting to maximize the value of patient-level health utility data for economic models
According to Sorrel E. Wolowacz, PhD, corresponding author, “clinical trials represent a valuable opportunity to gather health utility data. However, because most trials are designed chiefly to collect efficacy and safety data to support market approval (not to collect data for health economic models), an important opportunity to gather health utility data is often missed or problems can arise when applying data that has been collected in cost-utility models. Therefore, careful planning is needed early in the process to establish a well-thought out design for health-state utility collection in clinical studies. The Task Force recommendations are intended to help researchers to design the optimum program of utility measurement in clinical studies and to develop a strong scientific rationale for that design.”
The complete Task Force Report can be found here. ISPOR is also offering a new Short Course related to this topic—Collecting Health-State Utility Estimates for Economic Models in Clinical Studies—that will be offered for the first time on October 29 at the upcoming ISPOR 19th Annual European Congress.
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