Clinical Trials Transformation Initiative (CTTI)

Trust in clinical research isn’t just a buzzword — it’s a measurable outcome.  For too long, we’ve talked about trust as an abstract goal, but what if we could turn trust into action? At the IncluDE Site Solutions Summit on Monday, April 7, CTTI’s Sabrena Mervin-Blake joins other experts for a deep dive into real-world strategies to:  ✅ Move beyond outreach and optics to build lasting confidence  ✅ Foster authentic community relationships that drive participation  ✅ Rethink investigator engagement to break down barriers If you’re ready to transform the way we approach trust in clinical research, this session is for you. Let’s stop talking about trust and start making it happen. #SCRS2025 

The MTT Project is driving progress toward a more efficient, inclusive, and data-driven clinical trial ecosystem. Looking ahead, we’re excited to share our findings and continue shaping the future of trials in 2025. Learn more: https://bit.ly/41FGFZR

Decentralized clinical trial elements (DCT) were widely used in cancer trials leading to FDA approval during the pandemic, as highlighted in a recent publication by the FDA OCE and CTTI, published in the Clinical Cancer Research journal. Nearly all respondents (95%) incorporated DCT elements such as remote monitoring and telemedicine and most intended to implement in future trials despite site-level challenges. 🔗 Read more at: https://bit.ly/4j02ZnX

Register now and save the date to join CTTI's Sabrena Mervin-Blake and colleagues for a discussion on the tools and initiatives being implemented to enhance clinical trial access and representation.

ICYMI: Morgan Hanger shares results from CTTI survey that identifies why many PIs drop out after a single trial. Listen now!

CTTI’s commitment to transforming clinical trials is making waves! Our episode on the Xtalks Life Science Podcast, featuring Morgan Hanger, was the most popular episode of 2024! We’re honored that our conversation on advancing clinical research resonated with so many industry leaders. This recognition reinforces the importance of collaboration, innovation, and evidence-based solutions in shaping the future of clinical trials. A huge thank you to Xtalks for providing a platform to share insights that drive meaningful change. And, of course, thank you to those who listened for engaging in this critical conversation! Missed the episode? Catch up here: https://lnkd.in/dYGd-F8q

A new publication from the FDA Oncology Center of Excellence (OCE) and the Clinical Trials Transformation Initiative (CTTI) highlights the role decentralized clinical trial (DCT) elements played during the COVID-19 pandemic in cancer trials leading to FDA approvals. The study, which included 19 responses across 13 sponsors, found that nearly all participants (95%) incorporated DCT components such as remote monitoring and telemedicine to overcome pandemic-related disruptions and most intended to utilize DCT elements in future cancer registrational trials. Site-level challenges—like regulatory, technological, and institutional barriers—must still be addressed. However, in this sample of oncology clinical trials, DCT elements were widely used and led to data quality suitable for FDA review and approval. 🔗 Read more at: https://bit.ly/4j02ZnX

In September 2023, CTTI launched the Measuring Trials Transformation (MTT) Project to track progress toward the Transforming Trials 2030 (TT2030) vision. Introduced in 2021, this vision outlines how clinical trials should evolve by 2030 to become more efficient and inclusive, focusing on five key domains: patient-centeredness, integration with health processes, trials designed with a quality approach, data-driven approaches, and improving population health. The MTT project developed a Metrics Framework to measure progress across these domains by creating specific benchmarks for understanding the state of clinical trials both today and in the future. Since its launch, CTTI’s Measuring Trials Transformation team has made significant progress in refining the metrics framework by reviewing over 100 public comments and incorporating feedback to improve the set of metrics. From the broader framework, the team identified nine high-priority metrics to focus on for data collection and analysis. The team is currently analyzing original trial documentation from CTTI’s AACT database of Phase 3 interventional trials conducted at U.S. sites between 2018 and 2024 to be able to answer key metrics. Looking ahead, CTTI plans to release the full framework and initial findings on our website in 2025, which will inform discussions at the inaugural State of Clinical Trials: Charting the Path Forward meeting on May 22, 2025. We look forward to continuing this vital work and sparking meaningful conversations to shape the future of clinical trials. 🔗 Learn more about CTTI's MTT project: https://bit.ly/41FGFZR

A new publication from the FDA Oncology Center of Excellence (OCE) and the Clinical Trials Transformation Initiative (CTTI), published in the Clinical Cancer Research journal, examines how decentralized clinical trial (DCT) elements were used during the COVID-19 pandemic in cancer trials that supported an FDA approval.    The study, which included insights from 19 responses across 13 sponsors, reveals that nearly all respondents (95%) used DCT elements, such as remote site monitoring and telemedicine, to overcome pandemic-related disruptions. Although several site-level barriers must be addressed, respondents indicated they were likely to integrate DCT approaches in future registrational oncology trials. Read more at: https://bit.ly/4j02ZnX

📰 In excitement for Xtalks Clinical Edge Issue 4, we’re revisiting the highlights of Issue 3, which focused on the critical importance of patient diversity in clinical research. This edition featured exclusive insights from Aida Habtezion at Pfizer and Moreno Perugini at Nestlé Health Science, along with leaders from Premier Research, H1, Clinical Trials Transformation Initiative (CTTI), Foundation for the National Institutes of Health, and Regeneron. Get inspired by their groundbreaking perspectives and stay tuned for our upcoming Issue 4! #PatientDiversity #ClinicalResearch #Pharma #LifeSciences #ClinicalTrials #Innovation