The Clinical Trials Transformation Initiative (CTTI) held a multi-stakeholder Expert Meeting on September 21 to discuss embedding aspects or elements of trials into clinical practice. The goal is to have care inform research and research inform care, therefore, CTTI created a set of recommendations to facilitate the integration of randomized, interventional trial elements into clinical care. Although trials and key initiatives are already paving the way, including the ACTIV-6 Study, the RECOVERY Trial, the Coalition for Advancing Clinical Trials at the Point of Care (ACT@POC), and the National Patient-centered Outcomes Research Network (PCORnet), challenges remain in driving change and measuring the impact of this change. At the Trials in Clinical Practice Expert Meeting, held in Washington, D.C., participants identified pain points of embedding trial elements, shared how CTTI recommendations can overcome those pain points, and brainstormed ways to measure implementation of the recommendations.  

Dr. Janet Woodcock, Principal Deputy Commissioner of the U.S. Food and Drug Administration, reiterated the imperatives for conducting trials as part of clinical practice, indicating that we have inadequate evidence for care, lack of representativeness of most Americans and health care settings, and an underperforming emergency response mechanism for national health crises. 

Meeting attendees identified some important themes: 

• The ability to embed aspects of a trial (eligibility and patient identification, informed consent, randomization, intervention, trial data acquisition, and evidence integration) will depend on a variety of factors:  
  • Aligning trial design with clinical workflow to minimize provider and patient burden 
  • Ensuring site readiness with appropriately trained staff and technology resources 
  • Defining clear channels of accountability 
  • Raising awareness of the value of research and its subsequent impact on care.  
• Technology and reusable networks can help overcome some of the barriers, as can changes in culture and policy and good partnerships with patient groups, health system leaders, and IT leaders. 
• CTTI recommendations provide design and operational clarity to embed trial elements, but their adoption will require engagement with health care providers, technology support, and ways to measure progress. 

Meeting attendees also discussed how to measure whether adoption of CTTI Trials in Clinical Practice recommendations is improving the quality and efficiency of trials.  

Initial themes fell into two camps:  

1. Measures of progress in clinical trial quality 
2. Measures of progress towards a learning health care system.

To assess progress of clinical trial quality, measures might include:  

• improved enrollment/retention rate 
• whether trials have enrolled reflective and representative populations that align with those being cared for 
• participant and health care provider satisfaction/experience with research.  

To assess progress at the learning health system level, measures might include: 

• whether embedded trials are producing impactful, reliable results that are integrated into clinical decision making 
• the proportion of practices in the health care ecosystem that are involved in research 
• changes in reimbursement policies 
• involvement of medical journals that report on elements embedded into care.