CTTI Project: Embedding Clinical Trials into Clinical Practice
CTTI Project: Developing Novel Endpoints and Planning Decentralized Trials
CTTI Project: Embedding Clinical Trials into Clinical Practice
CTTI Project: Investigator Community
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CTTI Project: Clinical Trials Issues Related to COVID-19
Topics Included: Data Collecting and Reporting, Ensuring Quality, Innovative Trials, Patient Engagement, Recruitment, Regulatory Submissions + Approvals, Safety, Site Planning
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The recording for the hybrid public workshop on AI in Drug and Biological Product Development convened and hosted by the U.S. Food and Drug Administration (FDA) and Clinical Trials Transformation Initiative (CTTI), held August 6, is now available. Over 9,000 registrants from diverse backgrounds and perspectives joined to explore the responsible use of AI in drug development.
During the workshop, we learned from experts as they discussed guiding principles for the responsible use of AI in the development of safe, effective, and high-quality drugs. Drawing on real case examples, experts discussed their rationale for particular approaches, shared their methods for evaluating success, recounted challenges and obstacles, explored options for scaling and wider applicability, and outlined considerations for moving forward. Presentations can also be found here.
Topics Included: Data Collecting and Reporting, Innovative Trials, Site Planning
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The FDA recently issued new guidance titled “Integrating Randomized Controlled Trials for Drug and Biological Products Into Routine Clinical Practice Guidance for Industry.” Those looking to put concepts from the guidance into action will find a range of valuable resources in CTTI’s Trials in Clinical Practice Toolkit. From recommendations and a site feasibility tool to case examples, these resources provide organizations and individuals with actionable operational and trial design considerations noted in the guidance.
CTTI Senior Project Manager Lindsay Kehoe provides further insight in the recent Clinical Leader article, “Putting It Into Practice: Why We Need Embedded Clinical Trials,” highlighting the need to incorporate elements like randomization and informed consent from trials into clinical practice to bridge the gap between research and practice. She underscores the potential for this integration to lead to a boost in knowledge, reduction in duplication of resources, and ultimately, enhanced patient care. Kehoe suggests that integration of trial elements is not all or none, benefits can be seen regardless of their number, and emphasizes the need for data to be relevant and reliable. She concludes that the success of this integration hinges on several factors: access to appropriate data, alignment of trial design with clinical workflow, preparedness of sites, clear accountability, and increased awareness of the value of research.
The new guidance also emphasizes following a Quality by Design approach to streamline trials and proactively address risks of important errors. CTTI has developed a comprehensive Quality by Design toolkit, including recommendations, a principles document, and various resources that can help support implementation.
More information about CTTI’s Trials in Clinical Practice & Quality by Design work is available on CTTI’s website.
Despite widespread support for decentralization, real and perceived challenges remain, limiting wider implementation of decentralized elements. A new CTTI publication, published in the Journal of Therapeutic Innovation & Regulatory Science, explores three perceptions that are commonly heard as barriers to the adoption of decentralized approaches in clinical trials. Because the integration of these approaches has the potential to enhance accessibility, diversity, and to reduce the burden on participants and caregivers, it is crucial to understand which barriers can be readily addressed with existing strategies.
In this commentary, CTTI staff outline the three barriers to adoption, discuss the degree to which the perceived and real barriers can be overcome, and share existing resources sponsors and trial designers can use to address them.
A recording of CTTI’s Feb. 29 webinar unveiling a new tool that aids in assessing the feasibility of embedding clinical trial elements into clinical practice is now available.
The one-hour webinar included a welcome from CTTI Director of Projects Sara Calvert; a project overview from CTTI Senior Project Manager Lindsay Kehoe; a panel discussion focused on stakeholder perspectives related to the practical use of the tool; and a request for input on how to optimize the tool’s use.
Embedding elements of clinical trials, such as patient identification, informed consent, and data acquisition, into routine care reduces duplication of trial and care activities and promotes the development of a learning health care system. This can naturally lead to better decision-making, treatment options, and outcomes for patients.
This tool is a part of CTTI’s Embedding Trials in Clinical Practice work, which aims to enable health care settings to participate in embedded trials and assists sponsors with their design and conduct.
View the slide deck to learn more.
