A Look at CTTI's Portfolio
Actionable Tools and Resources
In 2024, CTTI introduced two essential resources-a report on improving the submission of clinical trial information to ClinicalTrials.gov and the Embedding Trials Feasibility Survey-to support more compliant, efficient, and transparent clinical research. These tools provide workable strategies for improving regulatory compliance, embedding trials into routine practice, and ultimately enhancing public trust in clinical research.
The 2024 CTTI Report: Improving Timely, Accurate, and Complete Registration and Reporting of Summary Results Information on ClinicalTrials.gov, released in January and featured in a CTTI public webinar in February, is an essential resource for sponsors, investigators, and study teams improve compliance with regulatory requirements for clinical trial registration and reporting. Developed in collaboration with the FDA, this report provides results of research into challenges of registration and summary results information reporting to ClinicalTrials.gov and makes suggestions for improvement of these aspects for applicable clinical trials. By fostering transparency about potential new treatments, this report supports better decision-making and higher public trust in clinical research.
"Making clinical trial information publicly available fulfills the commitment to volunteer research participants and also enhances public trust. This collaboration between the FDA and CTTI was instrumental in identifying challenges and proposing options for timely, accurate and complete registration of applicable clinical trials and reporting of summary results information on ClinicalTrials.gov."
Danielle Villata, FDA Project Lead
Coming Soon
CTTI continues to drive innovation in clinical trials with two upcoming tools designed to address critical challenges in trial design and execution. These resources, which are expected to launch in the first half of 2025, will equip stakeholders with practical solutions for fostering meaningful engagement and harnessing the power of advanced modeling techniques.
"Engaging All Stakeholders in Clinical Trial Design will improve engagement in the design of individual clinical trials by addressing the lack of comprehensive resources for obtaining meaningful input from all clinical trial partner groups in contrast to existing resources that focus primarily on sponsors. This new tool will bring together valuable thought-provoking information for clinical trial designers to consider during protocol development."
Kelly Franzetti, CTTI Senior Project Manager
Engaging All Stakeholders in Trial Design
Engaging the broad range of partner organizations and individuals from the earliest stages of trial design is increasingly recognized as fundamental to planning and conducting high-quality clinical trials. However, it's easier said than done. CTTI's project, Engaging All Stakeholders in Clinical Trial Design, is creating an engagement roadmap, robust recommendations, and supporting resources that will enable clinical trial designers to efficiently and effectively engage all partner groups and individuals across the trial design process. Building from previous work in patient engagement and Quality by Design (QbD), this project will provide tools for continuous and substantive engagement with all voices in clinical trials.
Disease Progression Modeling
Disease progression modeling integrates diverse data sources to enhance trial design and inform regulatory decisions. However, its full potential in model-informed drug development remains underutilized. In 2022, CTTI launched a project, Using Disease Progression Modeling to Advance Trial Design and Decision-Making, to advance understanding, consistent application, and appropriate integration of disease progression modeling for better decision making in clinical trials. In 2024, project leaders published a thought piece for unlocking the potential of disease progression modeling and are developing recommendations and a considerations framework tool for release in 2025.
"While some modeling and simulation approaches are well recognized in drug development, disease progression modeling's potential to improve clinical trials is not fully realized. The Disease Progression Modeling Project Team is excited to release new recommendations and tools early next year that will bring greater awareness of the unique value of disease progression modeling, when it should be considered over other tools or approaches, and provide considerations for what is needed and how to incorporate them."
Lindsay Kehoe, CTTI Senior Project Manager
New This Year
Al Emerging Practices Workgroup
In 2024, CTTI launched the AI Emerging Practices Workgroup, which created a dedicated forum for experts to explore AI applications in clinical trials and stay attuned to emerging trends through publications and case studies. The workgroup convened the first of five meetings in August, beginning an in-depth exploration of critical topics, including trial participant selection and recruitment, site selection and retention strategies, dose regimen optimization, and innovations in clinical trial data collection, management, analysis, and endpoint assessment. Led by CTTI senior project manager Lindsay Kehoe, the workgroup has brought together 16 experts from academia, health tech, life sciences startups, pharma, and regulatory agencies, complemented by case examples and special guests, to learn and refine best practices for AI integration in clinical research.
Driving Change Through Insight and Influence
Since its founding in 2007, CTTI has made a profound impact on the clinical trials landscape. Our case studies, outreach efforts, recommendations, and tools, empower innovation and accessibility across the clinical trials enterprise.
CTTI Resources in Action
In 2024, CTTI grew its Case Study Exchange to 53 examples of transformation. New case studies added this year include:
EMD Serono Quantifies Diversity, Equity, and Inclusion Progress Across its Organization Using CTTI's Diversity Maturity Model
Through CTTI's Diversity Maturity Model and recommendations, EMD Serono developed a comprehensive framework to measure and enhance diversity, equity, and inclusion (DE&I) across its research and development (R&D) efforts.
The case study highlights how they've:
- Built greater DE&I into every phase of their R&D processes
- Developed metrics to assess meaningful progress
- Customized CTTI's Maturity Model to align with the organization's structure and goals
By prioritizing diversity in clinical trials, EMD Serono is addressing long-standing knowledge gaps and ensuring its research benefits all patient populations.
Read the full case study to explore their strategies and lessons learned for improving DE&I in clinical trials.
Harnessing the Power of AACT: Driving Innovation in Clinical Trial Design and Analysis
CTTI's Aggregate Analysis of ClinicalTrials.gov (AACT) database is a free, publicly available relational repository that contains all information (protocol and result data elements) about every study registered in ClinicalTrials.gov. Each year there are numerous publications leveraging AACT.
As analytical and computational methods advance, we are seeing more sophisticated examples, such as Lindus Health's work on predicting the likelihood of trial termination, initiating draft clinical trial protocols, and standardizing trial outcomes to improve searchability and comparison. Lindus used data and documents from the AACT Database in combination with techniques like large language models and machine learning to enable the design of more robust and resilient trials, expedite the trial setup phase, and enhance trial data usability and standardization.
Learn more about additional use cases here.
Publications
In 2024, CTTI published five key manuscripts. Covering topics such as clinical integration, decentralization, digitalization, and inclusivity, these works contribute valuable insights to the evolving clinical trials landscape and underscore CTTI's unique contributions.
- Adoption of Decentralization: Are Our Perceptions Holding Us Back? Journal of Therapeutic Innovation & Regulatory Science, April 2024
- Digitalizing Health Trials by the Clinical Trials Transformation Initiative Nature Reviews Bioengineering, June 2024
- Overcoming the Barriers to Bringing Clinical Trials to AllTrials, September 2024
- The Potential of Disease Progression Modeling to Advance Clinical Development and Decision Making Clinical Pharmacology & Therapeutics, October 2024
- Embedding Clinical Trial Elements into Clinical Practice: Experiences from Trial Designers and Implementers Journal of Clinical and Translational Science, November 2024
Media Coverage
In 2024, many prominent media outlets including Applied Clinical Trials, Clinical Leader, Fierce Biotech, Xtalks Magazine and Xtalks Life Science Podcast highlighted CTTI's work.
- Best Practices for Complete Registration and Reporting of Summary Results on ClinicalTrials.gov Clinical Leader, March 2024
- Reservations, Great Plains and rural counties ripe for decentralized trials: Milken report Fierce Biotech, July 2024
- In Focus: Top Takeaways from FDA Final Guidance on Real-World EvidenceApplied Clinical Trials, September 2024
- Building Inclusive Trials: Insights from CTTI's Diversity InitiativesXtalks Magazine, September 2024
- Transforming Clinical Research: A Conversation with Morgan Hanger, Executive Director of CTTIXtalks Life Science Podcast, October 2024
