Innovative Trials

CTTI’s Trials in Clinical Practice Resources are Valuable for Those Looking to Design and Conduct Randomized Trials that Integrate into Routine Clinical Practice

CTTI News | September 23, 2024

Topics Included: Data Collecting and Reporting, Innovative Trials, Site Planning

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.

Recent News Feed

Recent Publication Reviews How CTTI’s Digital Health Trial Hub Can Unlock the Potential of Digitalizing Trials

Posted on by Hannah Faulkner

A new CTTI publication, published in Nature Reviews Bioengineering, reviews opportunities for and challenges to using digital health technologies in clinical trials and highlights CTTI’s Digital Health Trials (DHTs) Hub. Digital health technologies have the potential to transform evidence generation in clinical trials, from trial design and participant screening to data capture and analysis. However, digital health technologies introduce new challenges, including concerns around data protection and data quality. The wide variety of available technologies requires that sponsors carefully identify meaningful measures, select and test appropriate technologies for capturing these measures, and train site staff and participants to properly use the selected technologies.

CTTI’s DHT Hub includes tools and recommendations for developing novel endpoints, planning decentralized trials, selecting and testing digital health technologies, managing data, supporting sites, and interacting with regulators. These resources support the effective implementation of DHTs to bring therapies to patients more quickly and efficiently, aligning with CTTI’s Transforming Trials 2030 vision.

CTTI Publication Explores Perceived Barriers and Recommendations Surrounding the Adoption of Decentralization

Posted on by Hannah Faulkner

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. 

Recording Now Available: CTTI Unveils New Tool for Embedding Clinical Trials into Clinical Practice

Posted on by Hannah Faulkner

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. 

CTTI to Launch New Embedding Trials Feasibility Assessment Tool

Posted on by Hannah Faulkner

CTTI will host a free public webinar on Thursday, Feb. 29 at 12:00 p.m. EST to unveil a new tool for assessing the feasibility of embedding clinical trial elements into clinical practice.  

The webinar will include a welcome from Sara Calvert; a project overview from Lindsay Kehoe; a panel discussion that will focus on stakeholder perspectives related to the practical use of the tool; and an opportunity for you to help CTTI optimize its 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. 

However, integrating interventional clinical trials into clinical practice is complex, and operational direction is needed. Supporting recently released recommendations, CTTI created a new tool that aims to aid sponsors involved in early planning and design of a clinical trial by providing insight into site readiness and feasibility of integrating trials into clinical practice. 

Register for the free 60-minute webinar. 

How Much Evidence Is Enough? Research Sponsor Experiences Seeking Regulatory Acceptance of Digital Health Technology-Derived Endpoints

Posted on by Hannah Faulkner

How Much Evidence Is Enough? Research Sponsor Experiences Seeking Regulatory Acceptance of Digital Health Technology-Derived Endpoints

From Ideas to Implementation: ETH Zurich Helps Researchers Leverage Digital Innovation to Build Actionable Endpoints

Posted on by Hannah Faulkner

From Ideas to Implementation: ETH Zurich Helps Researchers Leverage Digital Innovation to Build Actionable Endpoints

CTTI Holds Meeting to Discuss Strategies for Advancing the Use and Acceptance of Disease Progression Modeling (DPM) in Clinical Trial Design & Decision Making

Posted on by Hannah Faulkner

The Clinical Trials Transformation Initiative (CTTI) held a multi-stakeholder expert meeting on March 6 to discuss strategies for advancing the use and acceptance of disease progression modeling (DPM) in clinical trial design and decision making. Meeting attendees discussed DPM and its current applications; explored opportunities, barriers, and best practices for advancing the use of DPM in clinical trial decision making; and proposed relevant metrics for monitoring and evaluating the recognition, value, and consistent use of DPM. CTTI will be using the ideas generated during this meeting and collecting case examples of DPM application in order to identify and catalog examples of how DPM can provide value for clinical trials – with the ultimate goal of developing and disseminating recommendations that address DPM best practices. 

The maturity and potential impact of model-informed drug development (MIDD) is recognized, but knowledge sharing and clear regulatory expectations are needed to realize its widespread use. FDA’s paired meeting program and the Fit-for-Purpose initiative are examples of programs that foster engagement and transparent communication but additional communication and pre-competitive collaboration is needed between the modeling industry, regulatory agencies, and the clinical community to advance consistent application of MIDD. 

During the meeting, attributes that allow for a successful application of DPM in a given context were discussed, leveraging the results from the CTTI DPM project team scoping review and expert panel presentations.  

  • Meeting attendees also discussed essential next steps for advancing the recognition,
    value, and use of DPM approaches, including the need to:
    ► Establish best practices and provide illustrative case examples.
    ► Develop a common language for disease progression modeling.
    ► Highlight the value and impact of DPM for a variety of stakeholders.
    ► Facilitate communication across stakeholders.
    ► Create metrics to monitor the changes in DPM acceptance and use within organizations and across the clinical trials enterprise (CTE). 

Overall, meeting attendees highlighted that the benefit of CTE-wide adoption of DPM would be faster, higher-quality drug development programs, and more diverse clinical trials.