Economic Outcomes in Clinical Studies

Collection of economic outcomes in the clinical trials are becoming more and more popular. Reporting of economic outcomes in the study is called “within-trial economic evaluation” and it has very high evidence level due to direct connection of clinical and economic data, originated from a single study.

Within-trial economic evaluations were very important in promoting many medical technologies, including cardiac resynchronization therapy for heart failure, transcatheter implantation of aortic valve for aortic stenosis, fractional flow reserve measurement for unstable angina and many others.

Every study, but especially, controlled one is a good candidate for collection of economic outcomes.

The reasons for collection of economic outcomes in single-arm studies can be:

  • Estimation resource use and cost, associated with technology
  • Informing inputs to health economic modelling
  • Development of matched cohort controlled study by linking study results to another study or patient registry

Incorporation of economic outcomes into randomized controlled trial enables classic economic evaluation.

Typically economic outcomes include resource use (e.g. hospitalizations, visits to specialists/GP, emergency visits, medications) and health-related quality of life. Not every questionnaire to evaluate quality of life is suitable for economic analysis. The science and art of within-trial economic analysis is in proper selection of relevant cost items and quality of life measure, reaching rational balance in loading of the study with economic outcomes (every additional measure increases complexity and cost of the study) and specific way of analyzing data.

Synergus can provide complete or selective support for planning and analyzing within-trial economic evaluation including:

  • Development of protocol of economic sub-study
  • Incorporation of outcomes in paperless study (CRF)
  • Analysis of the data and writing report/manuscript

Most of the medical devices company invest in maximum one or two controlled studies. It is very important not to miss opportunity to create additional leverage from clinical trial and with minor additional investment to create compelling economic story.

Contact us for more information