Author: Hannah Faulkner

Patient Engagement Collaborative Announces Eight New Members

Posted on by Hannah Faulkner

Today, the U.S. Food and Drug Administration (FDA) and the Clinical Trials Transformation Initiative (CTTI) announced eight newly selected representatives for the Patient Engagement Collaborative (PEC). The group of 16 patients, caregivers, and patient group representatives meets with the FDA several times a year and discusses a variety of topics such as improving communication, education, and patient engagement related to medical product regulation. Those selected to the PEC are expected to serve for two years. 

The eight new representatives are:  

  • Anna Ball 
  • Kelly Barta 
  • Ricki Fairley 
  • Liam McCarthy 
  • Andrea Meredith 
  • Patrick Moeschen 
  • Olga Torres 
  • Kathryn Washington 

The representatives were selected from 75 applications received in response to a Federal Register notice published in July 2023. These new members of the PEC include patients who have personal disease experience, caregivers who have personal experience supporting someone with a health condition, and representatives from patient groups who have direct or indirect disease experience. The selection committee, which included patient advocates, FDA staff from multiple centers, CTTI staff and several outgoing PEC members, worked to identify individuals with diverse perspectives and experiences who could meaningfully contribute and express the patient voice. 

“CTTI is thrilled once again to have eight new members of the PEC who will share their insights on patient engagement and research. CTTI’s Transforming Trials 2030 pillars envision a system that representative, accessible, and directly informed by patient preferences and experiences. Having patients as partners, especially through the PEC, is critical to our work. We also wish to thank the outgoing members for their invaluable perspectives during their term,” said Morgan Hanger, CTTI’s Executive Director. 

The PEC, a collaboration established by FDA and CTTI in 2018, is a group of patient organizations and individual representatives who discuss ways to enhance patient engagement. FDA and CTTI collaborate to involve representatives with a variety of perspectives including patients, caregivers and representatives from diverse patient organizations and communities. The PEC is run by the FDA’s Patient Affairs, which is dedicated to providing an inviting, welcoming and meaningful experience for patient communities to engage with the FDA. 

“Patient community experiences and opinions are essential to inform FDA’s regulatory work. The FDA listens closely to PEC members to integrate different perspectives into meaningful patient engagement and communication opportunities.” said Andrea Furia-Helms, M.P.H., Director of Patient Affairs, Office of Clinical Policy and Programs, FDA.  

Going forward, the PEC will continue the dialogue around how patient perspectives can inform the clinical trials enterprise and provide information and resources to enhance PEC members’ knowledge about FDA and CTTI activities to share with patient communities. Previous topics have included: providing enhanced information to patient communities to clarify FDA’s role; updating the PEC Framework; working to better understand COVID-19’s impact on clinical trials; creating new ways to collaborate with patient communities; promoting global collaboration of patient organizations; and enhancing communication between the FDA and patient communities.

The FDA and CTTI wish to thank the outgoing members for their service to the PEC over the past several years: 

  • Carol Abraham 
  • Julie Breneiser 
  • Sneha Dave 
  • Maria De Leon 
  • Sharon Lagas 
  • John Linnell 
  • James Pantelas 
  • Traceann Rose 

Since 2008, CTTI has included patient advocates on its Executive Committee, Steering Committee, and project teams and, today, nearly all of its more than 30 sets of evidence-based recommendations and associated frameworks and tools mention inclusion of patients as a critical part of the clinical trials process. 

Congratulations and Best Wishes to CTTI Executive Director Sally Okun on Her Retirement

Posted on by Hannah Faulkner

Today, Sally Okun, who has served as CTTI’s Executive Director since October 2021, is retiring after five decades in healthcare.  

“On behalf of the entire CTTI community, we congratulate Sally on her exceptional career and on her retirement,” said CTTI’s incoming executive director, Morgan Hanger. “Sally’s tenacity and gift for storytelling have had a remarkable impact on bringing person-centered research and care into the mainstream. As we move into a phase of AI-driven innovation, her vision for ethical, patient-led data stewardship is providing an invaluable foundation for CTTI. We are so grateful for her 50 years of contributions to healthcare and to the success of this organization.”  

During her 20 years as a nurse and palliative care specialist in the community setting, Sally worked with hundreds of patients and caregivers. At the online patient research network PatientsLikeMe, where she served in a variety of roles for 12 years including as vice president of policy and ethics, she led the national conversation on patient centricity and created an evidence base to support expanded use of patient-generated health data. More recently at CTTI, Sally has initiated enterprise-wide measurement, expanded our commitment to diversity in clinical trials, and empowered the team to be independent and creative.  

When Sally announced her retirement in August, she committed to ensuring a seamless transition to her successor. In October, CTTI announced Morgan Hanger’s promotion to Executive Director upon Sally’s retirement, and over the past two months they have doubled down on that commitment. With the support and guidance of the CTTI Executive Committee Chairs and team, Sally and Morgan have relied on their shared values of connection, openness, and integrity to stay focused on what matters: the health and growth of our team; exciting, relevant work; and partnership with our members and the FDA.  

“It has been a wonderful experience working with entire CTTI team in preparation for my retirement,” said Okun. “I am confident that the organization will flourish through the leadership of my dear friend and colleague Morgan Hanger.” 

Please join us in thanking Sally for her service to CTTI and wishing her well in her retirement. 

Holiday Greetings from CTTI: Reflecting on 2023 & Embracing the Future

Posted on by Hannah Faulkner

Throughout this year, we’ve had the pleasure of crossing paths with many of you at diverse locations around the world – from San Francisco and Boston, to the nation’s capital and the Big Apple, to Montreal and Riyadh. We shared our work at more than two dozen meetings, conferences, and events, and it’s been truly gratifying to see our community actively engaged in our work on a global level. 

In 2023, CTTI has redefined possibilities around some of the clinical trials enterprise’s most pressing challenges and made strides toward creating a more effective and efficient research process. We’re proud to share the results of those efforts in our 2023 CTTI Annual Report. 

As we usher in a new year with CTTI’s next generation of leadership, our strategy is to build on CTTI’s key strengths by offering new engagement and implementation opportunities with our members that are focused, flexible, and poised for impactful change, including: 

  • Last Mile Implementation: CTTI is well-known for launching products and recommendations to improve the quality and efficiency of clinical trials. Yet, we recognize that more is needed to drive sustainable and scalable change. Therefore, we will test innovative approaches to make CTTI recommendations easier to implement in a range of settings, including our website. 
  • Engagement Diversification: CTTI’s flagship multi-year project archetype is important and we appreciate that in-depth learning and meaningful multi-stakeholder consensus takes time. We are eager to forge different modes of engaging, including more dynamic conversations with members and with the FDA. With the increased accessibility of powerful AI tools, research is changing rapidly, presenting interesting opportunities to learn together by convening in new and interesting ways. 
  • Dynamic Collaborations: There’s growing attention from private and public sectors as the U.S. government (including OSTP, NIH, ARPA-H and the FDA) intensifies its focus on clinical trials modernization and readiness. We’re delighted by the new and growing initiatives from digital platform companies to bring the research experience closer to patients wherever they are. CTTI has a crucial role to play, and we’ll continue to partner with our members, related efforts, and organizations around the world to harness these moments for impact.  

To our CTTI community, we thank you. While we all come from different parts of this complex enterprise, our collective culture is strong and our commitment steadfast. As our organization transitions from one leader to the next, we will carry CTTI’s legacy forward together by building on the work of leaders and members, past and present, to shape the future of clinical trials that we all want for ourselves and our loved ones.  

As we set our sights on 2024 and beyond, look to CTTI to pick up the pace of innovation and transformation in respect to our mission. We wish you a wonderful holiday season and a prosperous new year! 

Recording of Virtual Public Workshop Now Available: Enhancing Diversity in Clinical Studies

Posted on by Hannah Faulkner

A recording for the virtual public workshop to enhance clinical study diversity convened by the U.S. Food and Drug Administration (FDA) and Clinical Trials Transformation Initiative (CTTI), held November 29 and 30, is now available.  

Day 1 of the virtual public workshop opened with welcoming remarks from Karen A. Hicks, Deputy Director of the FDA’s Office of Medical Policy (OMP). Following the opening remarks, Patrizia Cavazzoni, Director of the FDA’s Center for Drug Evaluation and Research (CDER), delivered the keynote address. Following the keynote, multiple speaker presentations and panel discussions were held, including topics such as an overview of clinical study diversity, establishment of clinical study enrollment goals, approaches to support the inclusion of underrepresented populations in clinical studies, and more. The first day concluded with closing remarks from Karen Hicks.    

Day 2 of the workshop began with opening remarks from Mathilda Fienkeng, Director of the FDA’s Division of Medical Policy Development at the OMP. Following the opening remarks, further presentations and panel discussions were held on approaches to support the inclusion of individuals with mental illness in clinical trials, how to use digital health tools to increase clinical study diversity, community engagement, and next steps to enhance clinical study diversity with respect to the FDA’s overall mission. The second and final day of the workshop concluded with closing remarks from Hicks. 

View the full slide deck to learn more about the methods to support the inclusion of various underrepresented populations in clinical studies.  

This workshop fulfilled a requirement under section 3603 of the Food and Drug Omnibus Reform Act of 2022 (FDORA). 

CTTI Publication Explores Stakeholder Reflections on Implementing the National Institutes of Health’s Policy on Single Institutional Review Boards

Posted on by Hannah Faulkner

A new CTTI publication, published in the Journal of Ethics and Human Research, explores stakeholder reflections on implementing the National Institutes of Health’s policy on single Institutional Review Boards (sIRB). CTTI interviewed 34 stakeholders with various roles in the single IRB process to gather perspectives about their experiences implementing the sIRB model, focusing specifically on the six goals of the NIH sIRB policy. Some stakeholders suggested that using the sIRB model has streamlined and reduced inefficiencies associated with local IRB model. However, new inefficiencies were created due to unclear roles, lack of systems and processes, and increased workloads for some stakeholders. 

These stakeholder responses suggest that standardizing the sIRB process and implementing new systems that support the NIH’s goal for enhancing and streamlining the IRB process are needed. For example, standardizing the roles and responsibilities of reviewing IRBs and relying institutions, improving the compatibility of IRB software, and having a central repository for institutional information may improve the efficiency of the sIRB process. CTTI utilized the findings of these interviews to inform an sIRB evaluation framework.

Recording of Virtual Public Meeting Now Available: Mitigating Clinical Study Disruptions During Disasters and Public Health Emergencies (PHEs)

Posted on by Hannah Faulkner

A recording of the virtual public meeting “Mitigating Clinical Study Disruptions During Disasters and Public Health Emergencies (PHEs),” convened by the U.S. Food and Drug Administration (FDA) and Clinical Trials Transformation Initiative (CTTI) held October 18th and 19th, is now available.  

Day 1 of the virtual public meeting opened with welcoming remarks from Janet Woodcock, FDA’s Principal Deputy Commissioner. Following the opening remarks, Jacqueline Corrigan-Curay of the FDA’s Center for Drug Evaluation and Research (CDER) provided an overview of the FDA’s activities and responses to address the COVID-19 public health emergency and clinical trial conduct disruptions. Following the presentations, three panel sessions were held and panelists discussed various topics related to clinical trial disruptions during COVID-19. The first day concluded with closing remarks from CTTI Executive Director Sally Okun.    

Day 2 of the meeting began with opening remarks from Celia Witten of the FDA’s Center for Biologics Evaluation and Research (CBER). Following the opening remarks, panel discussions were held on federal partners’ experience related to trial disruptions and strategies for emergency preparedness in clinical studies. The second and final day of the meeting concluded with closing remarks from M. Khair ElZarrad of the Office of Medical Policy at CDER. 

View the full slide deck to learn more about methods to mitigate clinical study disruptions during disasters and public health emergencies. 

For additional information on the FDA guidance on conduct of clinical trials of medical products during the COVID-19 public health emergency, please see the updated final guidance document. This meeting fulfilled a requirement under section 3605 of the Food and Drug Omnibus Reform Act of 2022 (FDORA).  

Please join us on November 29 and 30, 2023, for another FDORA virtual public workshop on enhancing clinical study diversity. Registration information and a full workshop agenda can be found here.