Clinical Trials Transformation Initiative (CTTI)

As noted in the recent Integrating Randomized Controlled Trials for Drug and Biological Products Into Routine Clinical Practice draft guidance, researchers and policymakers recognize that embedding research into routine clinical practice can enhance both research and patient care. By integrating key elements of clinical trials—such as patient identification and data collection—into health care practice, research efforts can be streamlined to reduce duplication of trial and care activities. However, administrative, cultural, and data-related challenges remain. To address these challenges, Clinical Trials Transformation Initiative (CTTI) recently published a paper in the Journal of Clinical and Translational Science. The publication highlights the importance of embedding randomized clinical trials into routine clinical practice and offers actionable recommendations for overcoming existing barriers.? ? Read more at: https://bit.ly/4hTJRrZ

Key takeaways from the Clinical track of DIA Canada's annual meeting: as we navigate the complexities of #clinicaltrials, it is crucial to embrace decentralized trials, leverage #AI, prioritize quality by design principles, and tailor study designs to make them more fit for purpose, all while ensuring robust data collection, interpretation, and collaboration among stakeholders. Moving forward, we must proactively engage with regulators, foster open communication and knowledge-sharing, address potential biases and data availability issues, ensure interpretability and explainability of AI models, and continually adapt our processes to maintain a patient-centric approach, optimize dosing strategies, and drive innovation while upholding ethical standards and regulatory requirements. #Canada24 is now a wrap! See you next year. #clinicalresearch #clinicaltrial #drugdevelopment #clinicaloperations Ted Trafford Dr. Kerstin Koenig Flora Noitsis Vantage BioTrials Clinical Trials Transformation Initiative (CTTI)

As we celebrate Native American Heritage Month, CTTI reaffirms our commitment to advancing diversity and equity in clinical trials. Native communities bring essential insights and wisdom to health research, helping shape a more inclusive and effective clinical trials enterprise. Through our diversity initiatives, CTTI is dedicated to making clinical trials more accessible, culturally informed, and responsive to the unique needs of diverse communities. We extend our gratitude to Native American leaders, advocates, and community members for their invaluable contributions to health research. Together, we’re making strides toward a more inclusive future for clinical trials. #NativeAmericanHeritageMonth?

Many thanks to Lindsay Kehoe from Clinical Trials Transformation Initiative (CTTI) for her passionate talk at today’s Next-generation Digital Biomarker Symposium at ETH Zürich on "Setting up Digital Health Trials." In her inspiring presentation, Lindsay explained what is needed to improve the quality and efficacy of clinical trials and offered valuable recommendations on how to get started, focusing on some key questions to consider before planning a digital health trial: Does a digital health trial make sense? How do I develop a novel endpoint using a digital health technology? How do I select and text a digital health technology? How do I plan for and address challenges associated with managing data from digital health technologies? How do I support patients and sites when conducting a digital health trial? What regulatory interactions are expected and what are the mechanisms to engage with regulators? Thanks to Noe Brasier and J?rg Goldhahn for organizing this symposium.

Are you ready for ICH GCP E6 (R3)? The upcoming updates bring new standards – and tomorrow, GSK’s Dr. Kerstin Koenig will help make sense of it all. Catch her session at 10:30 a.m. EST at the DIA Canada Annual Meeting, where she’ll share actionable strategies for applying Quality by Design principles to drive equality, prepare for inspections, and tackle recruitment head-on.? Don’t miss this opportunity to gain clarity on the impact of E6 (R3) and explore the powerful role of QbD in clinical trials. #Canada24 #GCP #QbD???https://bit.ly/CTTIevents

If you’ll be at the Next-Generation Digital Biomarker Summit this week, be sure to mark your calendar for an insightful presentation by J?rg Goldhahn and Lindsay Kehoe on “Setting up Digital Health Trials Supported by CTTI” on November 14!? This session will dive into the strategies and tools needed to set up clinical trials that integrate digital biomarkers and digital health technologies effectively. If you’re in clinical research or digital health, don’t miss this chance to learn how CTTI’s resources can help improve trial design, enhance data quality, and support regulatory readiness. https://bit.ly/CTTIevents? ? ETH Zürich

Join CTTI’s Lindsay Kehoe at the Next-Generation Digital Biomarker Summit on November 14!? ? Kehoe and ETH Zürich’s J?rg Goldhahn will be presenting “Setting up Digital Health Trials Supported by the Clinical Trials Transformation Initiative (CTTI).” This session offers a unique opportunity to gain insights into best practices for designing and conducting clinical trials that leverage digital biomarkers and digital health technologies, with CTTI’s expert recommendations and resources.? Whether you’re involved in clinical trial design, digital biomarkers, or innovation in healthcare, this presentation is a must-see! Join us for a look at how CTTI’s support can drive impactful and innovative clinical trials. https://bit.ly/CTTIevents??

I’m thrilled to share our latest article in?Health Affairs, calling for a coordinated, national strategy to close the long-standing gaps in representation within U.S. clinical trials. This issue affects everyone, and we're laying out a framework to build a more inclusive future in clinical research. Underrepresented groups — particularly Black, Latino, Native American, Asian, and rural communities — face disproportionately high rates of serious health conditions. Yet, they remain underrepresented in clinical trials, limiting both scientific understanding and access to critical advancements in care. The Diversity Convergence Project, launched by the?Clinical Trials Transformation Initiative (CTTI),?Milken Institute's FasterCures, the?Multi-Regional Clinical Trials Center of Brigham and Women's Hospital and Harvard (MRCT Center), and with contributions from the?The National Academies of Sciences, Engineering, and Medicine,?is working to change this. We’re advocating for a unified, cross-sector approach to ensure diversity, equity, inclusion, and access in clinical research. Our article highlights the key findings from our comprehensive publication,?Toward a National Action Plan for Achieving Diversity in Clinical Trials. We outline eight essential steps for creating a clinical trials enterprise that truly represents the diversity of our country and works toward equitable health outcomes. Join us.?This initiative needs support from all sectors — academia, industry, government, patient advocacy groups, and local communities. Let’s come together to build a clinical research system where every population has an equal opportunity to contribute to and benefit from scientific progress. #DiversityConvergenceProject #HealthEquity #ClinicalTrials #DEI

On Friday, November 15, GSK’s Dr. Kerstin Koenig will be speaking at the DIA Canada Annual Meeting on the timely topic of ICH GCP E6 (R3) updates and what these changes mean for our work in clinical trials. Her session, “Quality by Design in Clinical Trials: Hindrance or a Catalyst for Innovation?," will dive into how we can harness QbD principles to meet the new standards, stay inspection-ready, and enhance participant recruitment strategies.? By the end of the session, attendees will walk away with practical tools for:? - Navigating participant recruitment challenges more effectively.?? - Being fully prepared for regulatory inspections under the new guidelines.?? - Using QbD principles to boost clinical program outcomes.? Join us to understand how these updated guidelines can bring about true innovation in clinical research! #Canada24 #QbD #GCP https://bit.ly/CTTIevents

Thank you #PCORI for inviting me to speak on the Future of Patient- and Community-Engaged Comparative Effectiveness Research at the #PCORIAnnualMeeting2024. And thank you to the Clinical Trials Transformation Initiative (CTTI) members and experts from across the enterprise who made possible the CTTI work on #diversity and #patient group engagement that informed so many of the key considerations and resources I was able to draw from. ? A few other highlights from the meeting: - Learning about the various interventions, e.g., patient navigators, telemedicine, used to support treatment of Hepatitis C in those who use drugs. Plus it’s incredible to see how effective SOF/VEL x 12 weeks can be even with mixed levels of adherence in real-world settings. - Appreciating the depth of the youth mental health crisis and the barriers to access in care, the pressure on clinicians, the improving but enduring stigmatization – and on the flip side, the potential for peer support, more routinized screening, and sharing vulnerabilities and personal stories to drive a wedge in. - Getting to meet in-person and learn from my brilliant conference bestie Dr. Chidinma Ibe about trustworthiness and the power of creating genuine, reciprocal relationships with community health workers. ? ? Grateful to Greg Martin, Ashley Pidal, Anne Trontell, Nakela Cook and the full PCORI team for a terrific meeting.