The Clinical Trials Transformation Initiative (CTTI) held a multi-stakeholder Expert Meeting on May 11 to discuss recommendations for embedding elements of clinical trials into routine care. Different elements of clinical trials can be embedded into care, such as randomization, administration of study drug, and data acquisition. While this can promote the development of a learning health care system—where research will inform practice and practice will inform research—achieving this is complicated, and clarity is needed about how to operationalize the integration. Leaders and key stakeholders from across the clinical trials community participated in the meeting to help refine the recommendations and begin to strategize their implementation of them. 

Meeting attendees identified some important themes: 

• Alignment of research and care is needed. Data collected during routine care should be good enough to support both high quality care and research.  

“We would do well to clearly identify the high level of alignment needed for patient care and research.      Researchers need to get less special about themselves. We want to identify consequential decisions, when that decision occurs, why it matters, and when and how will we measure the consequences of that decision. Those three goals are 100% identical between research and care.” – Health Care System Provider

• We need transparency about roles and responsibilities. Embedding research into care will involve many stakeholders, including investigators, research sponsors, health care providers, regulatory bodies, operational technology providers, clinical research organizations, patient advocacy groups, health system leaders, funders, payers and, of course, patients. 

     “The front-line troops carrying out embedded trials – patients and clinicians – need to see a compelling research question or need that is personally valuable in the context of everything else they are trying to do. Some of that can be done by deep embedding in their environment to understand their needs.” – Funder 

• There is important work ahead of us. Meeting attendees provided feedback on the set of draft recommendations and suggested new tools to help implement the recommendations such as a decision tree tool to evaluate what trial elements could be embedded, a workflow support tool to clarify the kind of support needed to embed trial elements, and a list of technology examples that have or could enable embedding.  

CTTI is now using these findings—along with other research results and multi-stakeholder discussions—to refine recommendations and develop resources for release in late 2022. The project team will host another expert meeting on this topic in September.