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Accelerating Evidence Generation – Resources for Implementing a QbD Approach to Clinical Trials

CTTI Project: Quality by Design

 

Webinar Presenters:

  • Greg Pennock, EMD Serono
  • David Rodin, Amici Clinical Research
  • Ansalan Stewart, FDA
  • Karlin Schroeder, Parkinson’s Foundation
  • Steve Young, CluePoints

Webinar Resources:

Download Powerpoint Slideset

Resources:

 

New CTTI Project Aims to Offer Clarity Around Implementing Flexible Clinical Trial Approaches While Maintaining Data Quality

CTTI News | October 2, 2024

Topics Included: Innovative Trials

Implementing less rigid, more flexible approaches to clinical trials can increase patient and site access to research, improve participant satisfaction, facilitate real-world data use, enroll more diverse patient populations, and enable more generalizable trial results. Ultimately, these flexible trial approaches help sponsors bring new therapies to patients faster. However, despite their numerous advantages, questions remain about how to maintain data quality when adopting these strategies. High-quality trial data must be fit-for-purpose, credible, and reliable to support regulatory decision-making without jeopardizing participant safety or the integrity of trial results.

To address these questions, CTTI has started a new project to gather diverse perspectives on the advantages and disadvantages of flexible trial approaches. This includes methods such as embedding trials in clinical practice, incorporating decentralized trial elements, and allowing for setting adjustments during trial participation. Through multi-partner roundtable discussions, in-depth interviews, and surveys, CTTI will identify critical concerns and considerations for maintaining data quality when using flexible trial approaches. CTTI will outline case examples of flexible approaches in trials, identify common themes and responses from partners around these case examples, and consider a toolbox that outlines the strengths of implementing flexible approaches and provides recommendations for how to maintain data quality when incorporating them.

Pamela Tenaerts, CTTI project team lead and representative from Medable, emphasized the potential of flexible methodologies, stating, “Embracing more flexible methodologies for data collection enables us to better represent the populations we’re looking to serve while providing a better experience for participants.”

CTTI’s work in this area will help to increase the use of flexible approaches in clinical trials, resulting in improved trial access, participant satisfaction, enrollment of diverse patient populations, and trial efficiency.

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Recording of Hybrid Public Workshop Now Available: AI in Drug and Biological Product Development v2

CTTI News | September 23, 2024

Topics Included: Data Collecting and Reporting, Ensuring Quality, Innovative Trials, Patient Engagement, Recruitment, Regulatory Submissions + Approvals, Safety, Site Planning

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. 

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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.

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New Publication by CTTI, DCRI, the Duke Margolis Institute for Health Policy, and Protas Investigates Practices to Improve Evidence Generation System in Clinical Trials

CTTI News | September 17, 2024

Topics Included: Access to Clinical Trials

A new publication developed in collaboration by CTTI, the Duke Clinical Research Institute (DCRI), the Duke Margolis Institute for Health Policy, and Protas published in Trials highlights the current barriers to clinical trial transformation, areas of improvement, and actions needed to transform clinical evidence generation in the United States to better align with clinical care demands. A modern clinical trial infrastructure should prioritize trial accessibility, answer relevant study questions reliably, respond to public health emergencies rapidly, and more. 

The article identifies three key barriers that are currently impeding the transformation of the clinical trial evidence generation system – gaps in policy, inefficient infrastructure, and a lack of research prioritization. The United States’ health and data system has a fragmented infrastructure that can hamper the progress of clinical trials, especially at locations not accustomed to participating in research. Taking advantage of tools that increase trial efficiency will help significantly improve trial activation and participation. Regulatory support and appropriate policies are needed to implement a modern clinical trial infrastructure.  

Lastly, clinical trials are often deprioritized in health care settings because incentives to participate in trials are often limited and/or misaligned with clinical care activities. Health system leadership should encourage integration of trials more routinely into care delivery and help advance a learning health care system, especially as systems implement reforms to improve their clinical data infrastructure. 

Reliable and better evidence can be generated if there is continued movement towards more simple trial designs, regulatory clarity, the creation of a sustainable systemwide infrastructure, and coordinated leadership to improve the research and health care culture. 

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Recording of Hybrid Public Workshop Now Available: AI in Drug and Biological Product Development

CTTI News | August 23, 2024

Topics Included: Artificial Intelligence

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.

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