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.