Clinical Trial Modernization

The clinical research enterprise has evolved greatly over the past several decades, with a clear need for evidence-based policy research and solutions to better marry clinical care and research. Duke-Margolis has demonstrated policy leadership with portfolio focused on clinical trial modernization, which seeks to improve efficacy and efficiency of clinical trials with a broad goal of improving practical evidence generation and application. Innovating our approach to clinical trials is vital to translate research into clinical practice and in turn improve outcomes at the individual and public health level. New approaches to clinical trials have the potential to address longstanding access barriers that continue to limit representative access to trials for hardly reached populations. Moreover, during public health emergencies, having “warm-base” trial capacity in place to quickly respond and establish trials is imperative. Harnessing technology and policy innovation to target these challenges is a bold goal which requires collaboration across sectors. Duke-Margolis collaborates with many players in this space, including government, academic, industry, and health system partners, to achieve this vision together.

Current Projects

Coalition for Advancing Trials at the Point of Care

Clinical trials have been increasingly complex increasing the cost and work burden. Finding innovative solutions to conducting clinical trials at the point of care can both mitigate these higher costs while also ensuring better representativeness of patients.
ACT@POC is a coalition of health systems, health research organizations, community-based care organizations and other collaborators aligned around common goals to facilitate the design and execution of adaptive and responsive clinical trials at the point-of-care.
The key goals are to broaden patient and clinician participation, improve patient access to research at the point-of-care and support the development of practically relevant evidence that will drive decision-making by health systems, regulators, and payers to increase the availability of medicines to improve patient outcomes.

Clinical Trial Representativeness

Held a public meeting on clinical trial representativeness with the goal of exploring challenges to achieving representativeness and synthesizing best practices.
Clinical trials are affected by structural and systemic complexities that can make it challenging to address clinical trial questions effectively and equitably.
As the need for rapid and generalizable evidence grows, ensuring that research is conducted in groups representing the diversity of the American population is critical to effectively translate research findings to clinical practice.

Recently published works on representativeness with the Robert Wood Johnson Foundation

Enhancing Representative Enrollment through Point-of-Care Trials

Fostering Collaboration to Advance Shared Goals for Representativeness in Clinical Trials

Using RWE Data to Drive Research at the Point of Care

The Duke-Margolis RWE Collaborative has long explored how to effectively use electronic health records and other sources of real-world data to drive decision-making.
Through our work with point-of-care trials, we seek to understand how best to leverage EHRs to enroll, randomize and prospectively collect streamlined data from trial participants at the point-of-care.

FDA Collaboration

FDA has recognized the challenges of translation clinical research to everyday practice and the importance of operationalizing this research to improve health outcomes nationwide.
While the FDA has recognized the importance of this area of innovation, there are many real and perceived policy barriers to overcome to support the success of innovative clinical trials.
Specific public convening topics have included: "Advancing Implementation of Quality by Design and Risk-Based Monitoring for Quality Management of Clinical Trial Design and Conduct" and "Enhancing Adoption of Innovative Clinical Trial Approaches."

Past Work

Past Event Recordings

Comment Letters

Comment Letter to FDA on Diversity Action Plan Guidance, September 2024
Comment Letter to FDA on Good Clinical Practice Guidance (ICH E6(R3)), ACT@POC Coalition Letter, September 2023
Comment Letter to FDA on Decentralized Trials Draft Guidance, August 2023
Letter on Empowering Health Systems to lead with Evidence Generation, ACT@POC Letter
Open Letter from ACT@POC Coalition, November 2021