A recording of CTTI’s December 15 webinar unveiling the new recommendations on embedding clinical trials into clinical practice is now available. 

The one-hour webinar includes a welcome from Sally Okun, CTTI Executive Director; a keynote
presentation from Robert M. Califf, U.S. Food & Drug Administration; a project overview from Matthew Roe, AstraZeneca; and a panel discussion moderated by Lindsay Kehoe, CTTI Senior Project Manager. The panel discussion, which focused on stakeholder perspectives related to the
integration of the new recommendations, included: Sam Bozzette, National Institutes of Health;
Lara Jehi, Cleveland Clinic; Holly Robertson, Medidata; and Alandra Weaver, Crohn’s & Colitis
Foundation. 

The goal of creating these recommendations for embedding elements of clinical trials into care is to reduce trial inefficiencies and enable faster, more representative, evidence generation that improves patient care. The recommendations were developed for trials of drugs, devices, and biologics in close collaboration with stakeholders across the clinical trials enterprise. The first phase involved gathering input through qualitative, in-depth interviews with designers and implementers of interventional clinical trials that are embedded into clinical practice. The recommendations were drafted and refined with input from a multi-stakeholder project team and through Expert Meetings. 

View the slide deck to read more. 

CTTI today released new recommendations for embedding clinical trials into clinical practice. The goal is to have care inform research and research inform care, which will enable higher quality, more efficient, and more representative evidence for care. When clinical trials have elements embedded into health care delivery, the trials are more accessible to patients, can be conducted in close alignment with clinical workflows, and may use existing infrastructure and data sources for research. This is in contrast to the status quo where research data is collected separately from a clinical care setting, and may therefore produce results that do not reflect the real-world performance of medical products in the populations that will use them.

“We hope that by creating these recommendations for embedding elements of clinical trials into clinical practice, we can reduce trial inefficiencies and enable faster, more representative, evidence generation that improves patient care,” said Lindsay Kehoe, CTTI Senior Project Manager. “Higher quality, safer, more efficient care benefits everyone.”

The case for embedding elements of clinical trials into clinical practice is clear: 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. By facilitating the integration of randomized, interventional trial elements into clinical care, we may create efficiencies that help provide much needed evidence faster. Elements that can be embedded include eligibility and patient identification, informed consent, randomization, intervention, trial data acquisition, and evidence integration.

The recommendations were developed for trials of drugs, devices, and biologics in close collaboration with stakeholders across the clinical trials enterprise. The first phase involved gathering input through qualitative, in-depth interviews with designers and implementers of interventional clinical trials that are embedded into clinical practice. The recommendations were drafted and refined with input from a multi-stakeholder project team and through Expert Meetings.

More information on the Trials in Clinical Practice project can be found on CTTI’s website.

CTTI will host a free public webinar on Thurs., Dec. 15 to unveil new recommendations for embedding clinical trials into clinical practice.  

The webinar will include a welcome from Sally Okun, CTTI Executive Director; a keynote
presentation from a special guest with the FDA; a project overview from Matthew Roe,
AstraZeneca; and a panel discussion moderated by Lindsay Kehoe, CTTI Senior Project
Manager. The panel discussion, which will focus on stakeholder perspectives related to the
integration of the new recommendations, includes: Sam Bozzette, National Institutes of Health;
Lara Jehi, Cleveland Clinic; Holly Robertson, Medidata; and Alandra Weaver, Crohn’s & Colitis
Foundation. 

Embedding elements of clinical trials, such as randomization, administration of study drug, and
data acquisition, into routine care reduces duplication of trial and care activities and promotes the
development of a learning health care system. This will naturally lead to better decision-making,
treatment options, and outcomes for patients. 

However, integrating interventional clinical trials into health care settings is challenging and
complex, and operational direction is needed. As part of the Trials in Clinical Practice project,
CTTI has conducted in-depth interviews with study designers and implementers, gathered case
examples, and is now ready to share the recommendations it’s created to facilitate the integration
of randomized, interventional trial elements into clinical care; including, but not limited to, trials of
drugs, devices, and biologics intended for regulatory review. 

The free 60-minute webinar will begin at 12:00pm EST and registration is not required. 

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. 

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.