Pragmatic Trials

Interest is growing for the use of pragmatic trials in demonstrating real-world effectiveness of products. See how Optum™ can guide you in conducting these emerging studies.

Form Follows Function: Pragmatic Trials

Pragmatic trials combine “interventional” and “observational” elements in the same study. To date, pharmaceutical companies have sponsored a limited number of these types of studies, but there is growing interest in their use for demonstrating real-world effectiveness.

There is increasing need in the industry for post-authorization studies that provide real-world data for newly marketed products and that fulfill post-authorization commitments or European Medicines Agency (EMA) requirements. Likewise, health decision makers involved with coverage and payment policies are moving toward the development of policies that require more information on products in a “real-world” setting to guide pricing decisions.

Studies that are purely observational in nature help to address these questions and the need for real-world data, but can pose challenges when addressing issues of comparative effectiveness or head-to-head comparison. While some of these challenges can be addressed by improving the design of prospective observational studies, randomization in pragmatic trials provides a powerful additional tool to ensure that comparison groups are compatible.

Optum has the knowledge and experience to successfully conducting pragmatic trials as part of its Late Phase Research service offering. Contact us today to learn more about how we have helped customers increase their return on investment.