New guidance for data collection in clinical studies


The International Society for Pharmacoeconomics and Outcomes Research (ISPOR) Task Force on Good Practices for Outcome Research—Measurement of Health-State Utility Values for Economic Models in Clinical Studies—has published new practice guidance that provides a framework for the collection of health-state utility data in clinical studies.

The report, “Estimating Health-State Utility for Economic Models in Clinical Studies: An ISPOR Good Research Practices Task Force Report,” was recently published in Value in Health. The report was co-authored by RTI Health Solutions, a business unit of RTI International.

Health care researchers are increasingly trying 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 the strength of preference for a given health-related outcome in comparison with full health.

“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,” said Sorrel E. Wolowacz, PhD, RTI Health Solutions Head of European Health Economics and corresponding author.

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.

“Careful planning is needed early in the process to establish a well-thought out design for health-state utility collection in clinical studies,” Wolowacz said. “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.”

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