“Real world data (RWD) and real world evidence (RWE) generation are inextricably linked to epidemiology,” said Kerina Bonar, epidemiologist, real world evidence, strategy and analytics, Icon Commercialisation and Outcomes.
To further discuss this link, we caught up with Bonar to examine the benefits and challenges of hybrid study designs.
Outsourcing-Pharma (OSP): What is a hybrid study and what are the advantages?
Kerina Bonar: Study designs are continually being evolved to meet the needs of drug development stakeholders and the wider scientific community.
Hybrid studies are an innovation in study design that combines specific elements of particular study designs to maximise the quality and rigour of the study output.
Such innovation in study design seeks to overcome the limitations in one study design by adding features from another which serves to increase the efficiency of the study design in terms of study operationalization, time and costs.
OSP: What are the challenges? And how are they addressed?
Bonar: The hybrid design is a bespoke study design that needs to be tailored to each study’s research question and objectives.
Hybrid studies can limit the involvement of the study participant and avoid the need to conduct a prospective observational study provided there is a clear understanding of the study data requirements to ensure that a hybrid study design can be leveraged.
OSP: What is the value of a cross sectional study design? How is it used with other study designs, such as medical chart review studies?
Bonar: The CSS design, which includes surveys and prevalence studies, is an effective study design to gather epidemiological data quickly to support drug development across the lifecycle.
CSS can be used to complement medical chart review (MCR) studies and overcome the latter study design’s dependency on routine data.
A hybrid CSS-MCR study design therefore enhances the MCR design by supplementing the data capture with the addition of a survey component which enables further data to be collected.
OSP: How is the CSS-MCR hybrid design advantageous?
Bonar: The hybrid CSS-MCR study design is beneficial for real world evidence (RWE) generation, and can allow for better future planning, as well as to guide the development of the next generation of real world studies.
OSP: In implementing such study designs, what are the key points to remember?
Bonar: Hybrid CSS-MCR studies should be designed in a well-considered manner, with the sampling strategy carefully decided at study inception.
In implementing this type of hybrid study, selection bias which can undermine the integrity of the study and robustness of the study estimates should be addressed.
Striving to employ (as far as possible) a probability sampling strategy with a passive data collection approach is recommended.