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.