Pragmatic Clinical Trials

Pragmatic Clinical Trials

We take novel approaches to answer important, patient-centered questions more efficiently.

Our Thinking

Randomized clinical trials are one of the primary methods to generate evidence that informs care, but there are significant challenges associated with the way these trials have traditionally been done. With high costs and lengthy timelines, many clinical trials are burdensome to investigators, sites, and patients.

Pharmaceutical companies and other organizations need to solve for these problems while maintaining access to high-quality data that lead to valid answers to important questions. The DCRI introduces solutions via pragmatic approaches that are revolutionizing the way clinical trials are conducted. We accomplish this in three main areas: study design, recruitment, and participant-centered research.

Adrian Hernandez, MD, MHS
Executive Director,
Duke Clinical Research Institute
Vice Dean, Duke University School of Medicine

"How do we conduct more efficient studies to answer important questions that impact patients?"

Adrian Hernandez, MD, MHS

Study Design

Our thought leaders design studies that include pragmatic elements in order to embed research into standard clinical care.

Other innovations we’ve applied to study design include:

  • Partially or fully virtual trials
  • Participant-friendly informed consent processes
  • Integration of real-world data sources, such as electronic health records

Recruitment

By streamlining recruitment, we shorten the enrollment period and recruit a study population that is more representative of patients seen in real-world care.

Other pragmatic approaches we’ve taken to improve study recruitment include:

  • Use of electronic health records to rapidly identify large cohorts of potential participants
  • Technology solutions such as online patient portals
  • Novel recruitment strategies that meet patients where they are

Participant-Centered Research

Pragmatic studies should be participant-centered, answering research questions that impact patients’ lives.

We put participants at the center of our research by:

  • Partnering with DCRI Research Together to ensure that our research meets patients' needs
  • Implementing novel engagement strategies to support study retention
  • Sharing study results once research is complete

Ensuring Quality Through Expertise

With a range of clinical, statistical, and operational experts on our team, we focus on conducting rigorous studies that produce high-quality, regulatory-compliant data.

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Caring for Patients

Our investigators are also practicing clinicians who care for patients regularly, and they bring a deep understanding of clinical challenges to their research.

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Diving into Data

Our statistical experts bring their experience with real-world data sources such as electronic health records to integrate data from different sources and clean datasets to make them research-ready.

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Implementing Ideas into Action

Our operational leaders, who have vast experience in conducting large, global trials, ensure our studies with pragmatic approaches are supported from protocol design to study's end.

Highlights

ADAPTABLE reaches 15K patients enrolled

ADAPTABLE Enrolls 15K Patients Using Electronic Health Records

ADAPTABLE, a trial designed to use pragmatic approaches to answer critical questions, reached its enrollment goal of 15,000 patients. This enrollment was completed partially through identifying patients via their electronic health records.

Robert Mentz, MD

A Pragmatic Design to Increase Trial Enrollment Rates

Robert Mentz, MD, discusses features of pragmatic heart failure trial TRANSFORM-HF with a representative from the trial's sponsor, as well as considerations for how pragmatic clinical trials will be conducted as they continue to gain importance.

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Pragmatic Approaches to Address Current Public Health Crises

The DCRI received more than $19 million in funding from the NIH for research projects related to preventing or treating opioid addiction. One of the projects is a coordinating center to support pragmatic studies working on this challenge.

ADAPTABLE: Utilizing a Pragmatic Approach to Find the Right Dose

ADAPTABLE, the first pragmatic clinical trial to use PCORnet®, the National Patient-Centered Clinical Research Network, aims to determine the optimal dose of aspirin for patients with heart disease.

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Answering Important Questions for Older Adults with a Pragmatic Trial

Karen Alexander, MD, discusses PREVENTABLE, a new pragmatic trial she is leading to ascertain whether statins can help prolong survival free of dementia or physical disability in adults 75 years of age or older. PREVENTABLE uses pragmatic approaches to meet patients where they are and efficiently answer a question that has significant impacts on older adults' health.