Pragmatic Trials

Pragmatic trials designed to integrate real-world data at scale

Using real-world data to identify patients, deliver interventions, and capture outcomes provides an efficient and more generalizable approach to traditional trials.

We can implement pragmatic trials across multi-site networks, embedded within our Point32Health payer data, in partnership with large national health plans, or through leveraging systems and data from among our many other research partners.

Pragmatic trials enable:

  • Efficient identification and recruitment of study populations: Using existing data sources to define and enroll eligible patients
  • Integration of interventions into routine care: Including the ability to support individual-, practice-, or payer-levelimplementation
  • Scalable follow-up for outcomes: Leveraging claims and EHR data for outcome capture without intensiveprimary data collection
  • Larger, more representative study populations: Supporting evaluation of real-world evidence across diverse settings

Our Approach

We design pragmatic trials that integrate randomization within real-world data systems, enabling advanced epidemiologic methods and scalability. Capabilities include:

  • Use of real-world data for study operations: supporting recruitment, intervention delivery, and analysis
  • Flexible randomization strategies: including individual- and cluster-level designs depending on feasibility
  • Integration with healthcare systems: embedding studies within routine workflows
  • Multi-site and distributed implementation: Nesting pragmatic trials within established multi-site research networks to achieve scale and consistency
  • Alignment with decision-making needs: ensuring designs are fit for regulatory, clinical, and policy contexts

Highlighted Publications

Effect of Mailing Educational Material to Patients With Atrial Fibrillation and Their Clinicians on Use of Oral Anticoagulants: A Randomized Clinical Trial

Authors: Pokorney SD, Cocoros N, Al-Khalidi HR, Haynes K, Li S, Al-Khatib SM, Corrigan-Curay J, Driscoll MR, Garcia C, Calvert SB, Harkins T, Jin R, Knecht D, Levenson M, Lin ND, Martin D, McCall D, McMahill-Walraven C, Nair V, Parlett L, Petrone A, Temple R, Zhang R, Zhou Y, Platt R, Granger CB

Published JAMA Network Open on May 2, 2022

Pragmatic guidance for embedding pragmatic clinical trials in health plans: Large simple trials aren't so simple

Authors: Cocoros NM, Gurwitz JH, Cziraky MJ, Granger CB, Harkins T, Haynes K, Li X, Parlett L, Seeger JD, Singh S, McMahill-Walraven CN, Platt R

Published in Clinical Trials on June 15, 2023

We design pragmatic trials that leverage real-world data to achieve the scale, efficiency, and rigor required for modern evidence generation.