How Healthcare Systems Are Redesigning Clinical Trials to Get Real Answers Faster

Clinical trials are moving out of sterile research labs and into the places where patients actually receive care. The National Institutes of Health (NIH) Pragmatic Trials Collaboratory is hosting a specialized workshop to teach researchers how to design and conduct clinical trials embedded directly within healthcare systems, generating evidence that reflects how treatments work in real-world conditions rather than controlled laboratory settings.

What Are Embedded Pragmatic Clinical Trials?

Embedded pragmatic clinical trials represent a fundamental shift in how medical research happens. Instead of recruiting patients to come to a research center, these trials integrate the research process into routine clinical care. Patients receive their normal treatment while researchers collect data as part of standard medical practice. This approach answers a critical question that traditional trials often miss: Does this treatment actually work for real patients in real healthcare settings?.

The distinction matters enormously. A drug might perform brilliantly in a tightly controlled trial with carefully selected participants, but fail to deliver the same results when used by diverse patients with multiple health conditions in busy community hospitals. Embedded pragmatic trials capture this real-world complexity, providing evidence that directly informs how doctors should actually practice medicine.

Why Should Healthcare Leaders and Researchers Care?

The healthcare system faces mounting pressure to improve treatment outcomes while controlling costs. Embedded pragmatic trials address both challenges simultaneously. They generate patient-centered evidence necessary to inform improvements in healthcare delivery without requiring expensive, time-consuming recruitment processes. Because these trials happen within existing healthcare workflows, they're often faster and more cost-effective than traditional clinical trials.

Additionally, embedded trials can answer important public health questions that traditional research struggles to address. Modern information technology capabilities—electronic health records, data analytics, and real-time monitoring systems—enable researchers to track patient outcomes at scale, across multiple healthcare systems simultaneously.

How to Prepare for the Future of Clinical Research

• Understand the Design Principles: Embedded pragmatic trials require different planning than traditional randomized controlled trials, including strategies for integrating research into existing clinical workflows and leveraging electronic health records for data collection.
• Learn from Real Case Studies: The NIH Collaboratory has conducted multiple embedded pragmatic trials that demonstrate how to overcome practical challenges, from patient recruitment within healthcare systems to managing data across different electronic health record platforms.
• Develop Problem-Solving Skills: Researchers and healthcare leaders need hands-on experience identifying and solving real challenges that emerge when embedding trials in clinical settings, such as maintaining data quality while minimizing burden on clinical staff.
• Build Collaborative Networks: Success requires partnerships between academic researchers, healthcare system leaders, information technology specialists, and clinical staff who understand both research rigor and practical clinical operations.

Where Researchers Can Learn These Skills

The NIH Pragmatic Trials Collaboratory is offering a half-day preconference workshop titled "Innovations in Embedded Pragmatic Clinical Trials" at the Society for Clinical Trials 47th Annual Meeting in Phoenix. The workshop runs from 1:00 to 5:00 p.m. on Sunday, May 17, 2026, at the Arizona Grand Resort & Spa.

The workshop format combines multiple learning approaches to build practical expertise. Participants will attend didactic presentations with ample time for questions, hear firsthand experiences and case studies from researchers who have conducted embedded pragmatic trials through the NIH Collaboratory, participate in small group problem-solving activities focused on real challenges, and engage in a facilitated panel discussion with experienced principal investigators.

By the end of the workshop, attendees will be able to describe the characteristics and utility of embedded pragmatic clinical trials, understand the unique opportunities and challenges of designing and implementing these trials within healthcare systems, and learn how modern information technology can be employed to address important public health questions.

The Bigger Picture for Medicine

This shift toward embedded pragmatic trials reflects a broader transformation in clinical research. The Society for Clinical Trials Annual Meeting theme this year is "Advancing Public Health: Clinical Trials in an Era of Cutting-Edge Information Capabilities," highlighting how technology and pragmatic approaches are reshaping the entire field. The conference brings together the clinical trials community from academia, pharmaceutical and device industries, government agencies, medical groups, and clinical research entities.

As healthcare systems increasingly adopt electronic health records and data analytics capabilities, the infrastructure for embedded pragmatic trials becomes more feasible. This creates an opportunity to generate the real-world evidence that patients, doctors, and healthcare administrators actually need to make informed decisions about treatment options and healthcare delivery improvements.