August 5, 2016: Embedded Pragmatic Clinical Trials

August 5, 2016: Embedded Pragmatic Clinical Trials


Embedded Pragmatic Clinical Trials: Triumphs and Tribulations


Joakim Ramsberg, PhD, Department of Population Medicine, Harvard Pilgrim Health Care Institute and Harvard Medical School, and the Swedish Agency for Health and Care Services Analysis


Pragmatic clinical trials, Embedded PCTs, Electronic health records, EHR, Healthcare systems, Evidence generation

Key Points

  • Embedded PCTs involve randomization (cluster or individual), pragmatic study designs, and data used from existing electronic sources. They are conducted in many settings, across different disease conditions, and involve different types of interventions such as screening, treatment, decision support, and organizational workflow.
  • Embedded PCTs are large in terms of numbers randomized and have a relatively inexpensive cost per participant, with 40% of embedded trials as low as $50 per patient.
  • More embedded PCTs could be conducted if there were more partnerships, incentives, systematic approaches, and prioritization.

Discussion Themes

How can we bridge differences in the incentives and economic priorities between researchers and healthcare delivery systems to facilitate embedded PCTs?

Are there strategies for organizations to take greater ownership of knowledge generation?

How do qualitative methods, such as in-depth semi-structured interviews and associated data analyses, impact the costs of trials, and do methods exist for assessing the value of these potentially time-intensive procedures?

For More Information

Read more about ongoing pragmatic clinical trials at the Collaboratory’s Demonstration Projects webpage.

#PragmaticClinicalTrial, #pctGR
@PCTGrandRounds, @Collaboratory1, @PCORnetwork

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