Clinical Trials Transformation Initiative (CTTI)

Don’t miss your chance to make a difference! The Patient Engagement Collaborative (PEC) is still accepting applications! If you are passionate about promoting diverse patient perspectives, your voice is needed. Applications will be accepted until August 8, 2024 at 11:59 p.m. or until 75 applications are received. Apply today! https://bit.ly/4eVuhuw

The Hermansky-Pudlak Syndrome Network (HPS) is taking proactive steps to ensure patient voices are included in clinical trials for this rare disease. By leveraging CTTI's Patient Group Engagement (PGE) Recommendations, the Network is ready to lend its expertise when promising compounds for HPS enter clinical development. HPS is a rare disorder involving albinism, legal blindness, and a platelet defect causing bleeding. With no current treatments and severe complication, the HPS Network is tirelessly working towards a cure. Despite the challenges, including the rarity of the disease and lack of ongoing trials, the Network has creatively integrated itself into the pharmaceutical development industry. By using CTTI's PGE Recommendations, they’ve set ambitious goals, hosted workshops, and fostered alignment with regulatory agencies.    The impact is evident: successful grants, growing membership, and a stronger voice in the research community. The HPS Network’s journey is a testament to the power of patient advocacy and proactive engagement.    Read the full case study to learn more about their remarkable efforts and the invaluable role of patient groups in clinical research. https://lnkd.in/eq9zZT22

Clinical Trials Transformation Initiative (CTTI) is pleased to announce the selection of two new Steering Committee patient/caregiver representatives! Ella Balasa and Megan O’Neil both bring unique experiences and perspectives that will help to communicate patient needs and advance CTTI’s Transforming Trials 2030 vision. Learn more about how these exceptional new members will help us to drive positive change and advance #clinicaltrials. Read more: https://bit.ly/3zPTvKO

The Patient Engagement Collaborative (PEC) is now accepting applications! If you or someone you know has the desire to bring diverse patient perspectives into discussions with the FDA and Clinical Trials Transformation Initiative (CTTI) we invite you to apply online. The application period is open until 11:59 p.m. Eastern Time on August 8, 2024 or until 75 applications are received. Be sure to apply soon! Learn more at https://bit.ly/4eVuhuw

Looking at historical clinical trial data allows us to better predict study outcomes. By leveraging Clinical Trials Transformation Initiative (CTTI)'s extensive repository of trial data, we’re able to use #machinelearning to make data-driven decisions and accelerate protocol development based on these predictions. Read the full case study: https://lnkd.in/e4qEkzxT #artificialintelligence #protocolwriting #clinicaltrials

The agenda for the FDA & Clinical Trials Transformation Initiative (CTTI) August 6 AI Workshop is now available! Learn more about the workshop, meet the speakers, check out pre-read materials, and register if you haven't already on the meeting webpage. In-person registration ends soon! https://lnkd.in/e2zAmYf8

Calling all patients, caregivers, and patient group representatives! Are you interested in promoting more meaningful #patientengagement with the FDA? Apply today to join the Patient Engagement Collaborative (PEC)! Applicants will be considered based on their ability to represent diverse patient perspectives on topics like patient engagement, education, and communication related to medical product regulation. Applications will be accepted until 11:59 p.m. Eastern Time on August 8, 2024 or until 75 applications are received, whichever happens first. Only complete applications will be considered. We encourage you to apply early. Learn more at  https://bit.ly/4eVuhuw

Reminder: Clinical Trials Transformation Initiative (CTTI) and the FDA joint free hybrid workshop on Artificial Intelligence in Drug & Biological Product Development is about a month away! We hope you can join our representatives from academia, clinical research organizations, drug sponsors, medical device sponsors, patients, and other interested parties as they share their experiences and approaches for the responsible use of #AI in drug & biological product development. https://bit.ly/3JLCqU9  

Great to be at White House Office of Science and Technology Policy Clinical Trials Forum yesterday for the announcement of the FDA draft guidance on Diversity Action Plans. There has been tremendous momentum and leadership since the COVID-19 pandemic on addressing the challenges across the U.S. clinical trials ecosystem to enable more innovative trials that answers questions that matter to patients but also ensure we're closing the gap in access to clinical trial participation across all communities in the U.S. The National Academies latest review since the landmark study on Unequal Treatment, 20 years ago, shows that progress has stalled in addressing the health of racial and ethnic minorities in the U.S. Such persistent inequalities contribute to millions of pre-mature deaths and costs the U.S. hundreds of billions of dollars annually as the evidence demonstrates. The clinical trials ecosystem needs to be part of the solution in bringing underserved communities into both research and care. We need to leverage multiple access points to reach the community. We need a National Action Plan for Diversity in Clinical Trials and the framework developed by FasterCures, Clinical Trials Transformation Initiative (CTTI), and the Multi-Regional Clinical Trials Center of Brigham and Women's Hospital and Harvard (MRCT Center) and over two hundred stakeholders can serve as a guide for prioritized system-wide collective actions. https://lnkd.in/g9vqwVN4 A new report from Milken Institute further demonstrates that distance continues to remain an obstacle for access to trials and those with high-prevalence of disease are the furthest away. https://lnkd.in/gDG4WDAH Thanks to all the work being done by stakeholders in the research ecosystem with communities and continuing to see progress being made. Ramita Tandon Jeff Allen Silas Buchanan Dr. Elizabeth Ofili Shari Ling

What a remarkable week at #DIA2024 in San Diego! Our very own Sara Bristol Calvert and Summer Starling, DrPH, MPH from CTTI took the stage to deliver four engaging presentations alongside industry experts. They shared insights on evidence generation, the state of clinical trials, disease progression modeling, and how the combined efforts of #ACTEU, FDA, World Health Organization, and CTTI are strengthening the clinical trials enterprise. A special mention must be made of our steering committee patient representative, Philip Green, who brought a unique and invaluable perspective to the Disease Progression Modeling session. Adding to the highlights of DIA, CTTI hosted a dinner with guest speaker Ana Zanoletty from the European Medicines Agency (EMA), who led an insightful discussion about clinical trials trends in Europe and how ACT EU is facilitating innovation. A heartfelt thank you to our members and special guests for their participation. Reflecting on the wealth of insights and progress unveiled at #DIA2024, we are filled with a sense of anticipation and enthusiasm for the year ahead, especially as we see the alignment of meeting themes with CTTI’s groundbreaking work in the areas of Quality by Design, Disease Progression Modeling, Diversity in Clinical Trials, and the Use of Artificial Intelligence. We are inspired by the potential of these advancements to catalyze innovation, improve patient outcomes, and revolutionize the clinical trial landscape.  With a spirit of collaboration and continued effort, we are optimistic about making significant strides towards realizing CTTI’s 2030 vision.