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CTTI News + Happenings

Publications

CTTI Publication Provides Recommendations for Disease Progression Modeling in Medical Product Development

Disease progression modeling (DPM) has the potential to support greater efficiency and better decision-making in clinical development, yet it remains underutilized compared with more established model-informed drug development approaches.

Artificial Intelligence | CTTI News

New Resource Highlights Key Insights from the FDA/CTTI Workshop on Artificial Intelligence in Drug and Biological Product Development

A new summary captures key themes and insights from the FDA/CTTI Workshop on Artificial Intelligence in Drug and Biological Product Development, including current and emerging AI applications, implementation challenges, and...

Patient Engagement | CTTI News

CTTI Releases Executive Summary from Patient Summit

On April 28, 2026, patients, caregivers, and advocates gathered for the CTTI Patient Summit to discuss perspectives on the use of AI in clinical trials, the reuse of patient data,...

Patient Engagement | CTTI News

Designing Trials for the Data We’ll Need Next: Dana Lewis on Participant Burden, Researcher Burden, and Consent in the AI Era

In advance of CTTI’s Patient Summit, Dana Lewis spoke with Morgan Hanger about data capture, consent, researcher assumptions, and why many trials remain anchored in outdated models.

CTTI News

Holiday Greetings from CTTI: Bridging Vision and Impact in 2025

Highlighting a year of progress, partnership, and impact across the clinical trials ecosystem.

Artificial Intelligence | Webinars

Artificial Intelligence in Drug & Biological Product Development Hybrid Public Workshop 2025

Access the agenda, slides, and recording from the 2025 AI in Drug and Biological Product Development Hybrid Public Workshop.

Artificial Intelligence | CTTI News

FDA, CTTI Convening 2025 Hybrid Public Workshop on Artificial Intelligence in Drug & Biological Product Development

Registration is now open for the second Hybrid Public Workshop on Artificial Intelligence in Drug and Biological Product Development, hosted by the U.S. Food and Drug Administration in collaboration with...

Regulatory Submissions + Approvals | Webinars

CTTI’s Disease Progression Modeling Recommendations & Tool Launch

Webinar Launching Disease Progression Modeling Recommendations and Framework

Regulatory Submissions + Approvals | CTTI News

CTTI Releases New Recommendations to Guide Use of Disease Progression Modeling in Medical Product Development

CTTI today released new recommendations to support the effective use of disease progression modeling (DPM) in medical product development.

CTTI News

Optimizing Flexibility and Data Quality in Clinical Trials: Bringing Clarity to DIA Global 2025

At this year’s DIA Global Annual Meeting, Lindsay Kehoe, senior project manager at the Clinical Trials Transformation Initiative, chaired a panel under Track 8 – R&D Quality and Compliance –...

Clinical Trials Landscape | CTTI News

New CTTI Project Aims to Develop Framework for Assessing U.S. Clinical Trial Site Capacity and Readiness for Public Health Emergencies

In recent years, concerns have been raised about the limited real-time awareness of U.S. clinical trial sites’ capacity and capabilities, including their ability to support a coordinated and effective response...

Innovative Trials | CTTI News

CTTI to Launch New Recommendations on Disease Progression Modeling in Free Public Webinar

CTTI will host a free public webinar on Tuesday, July 8, to introduce new recommendations for using disease progression modeling (DPM) to improve medical product development.

Events

CTTI Webinar

Join us for the release of our new Disease Progression Modeling Recommendations

CTTI News

Inside the State of Clinical Trials: Perspectives, Problems, and Pathways Forward

The Clinical Trials Transformation Initiative (CTTI) convened 150 clinical trials leaders, patients, policy influencers, and trialists in Washington, D.C., on May 22 for a dynamic meeting focused on the state...

Events

Bioethics International & EY 2025 Roundtable: Ethics, Trust + Patient Centricity in Pharma – Defining Metrics for Success

Establishing a Global Industry Reporting Standard for Clinical Research Data: Public health, ethics, and business considerations in response to Declaration of Helsinki


Events

DIA Global Annual Meeting 2025

Do Flexible Trial Approaches Impede Data Quality? Perception vs Reality

Events

DIA Global Annual Meeting 2025

Building Upon Quality by design and Risk-based Monitoring Implementation Momentum


Clinical Trials Landscape | CTTI News

Measuring Trials Transformation (MTT) Project Update: Tracking Progress Toward Transforming Clinical Trials

In September 2023, CTTI launched the Measuring Trials Transformation (MTT) Project to track progress toward CTTI’s Transforming Trials 2030 (TT2030) vision. Introduced in 2021, this vision outlines how clinical trials...

Formats

CTTI Project