Study designs and real-world data sources are evolving to meet drug development needs.

Cross-sectional surveys (CSS) and medical chart reviews (MCRs) are both common study designs, and each has its strengths and limitations. However, many of those limitations can be overcome through a hybrid design approach that uses both types of study designs to enhance each another. Whereas at one time, hybrid studies were difficult to do, they can now be performed efficiently, thanks to the availability of comprehensive, electronic medical records (EMR) databases.

A hybrid CSS-MCR study enhances the MCR design by supplementing the capture of chart data with a survey component so that additional data can be collected. Each component of the hybrid study is conducted in the same manner as standalone CSS and MCR studies – after data is collected from the chart review, patients are surveyed to provide missing information or evaluate outcomes. By thus combining these study types, sponsors reap the benefits of:

  • The ability to examine causality via longitudinal follow-up
  • Reduced cost, as compared to a prospective study design
  • Lower participant burden, since surveys can begin where the chart review left off
  • Potentially higher response rates given that surveys can be shorter

Hybrid studies, however, must be designed in a way that ensures that the findings are robust and meaningful, and generalisable to the population of interest. There is a risk of introducing bias such as selection bias and misclassification bias in both the survey and MCR study designs. These biases and other statistical issues, including uncontrolled confounding, could render the findings of a hybrid study less reliable, so it is advisable to rely on the advice of an epidemiology experts when designing these studies.

ICON’s Epidemiology practice provides a comprehensive range of stand-alone services as part of a complete package of integrated services with our health economics, patient reported outcomes (PRO) and late-phase operations teams. For more information, please contact one of our experts.

This blog is an edited version of “Innovation In Epidemiological Research: Real-World Evidence Generated Through Hybrid Studies” which appeared in Clinical Informatics News on 4th December 2018. To view the full article, please visit http://www.clinicalinformaticsnews.com/