CTTI News

CTTI Announces Promotion of Morgan Hanger to Executive Director

Posted on by Hannah Faulkner

Today, CTTI proudly announced Morgan Hanger as its next Executive Director.  

“CTTI has been at the center of advancing clinical trial transformation through public-private collaboration, and that leadership will continue under Morgan Hanger,” said Dr. Mark McClellan, CTTI Executive Committee Chair, and Founding Director, Duke-Margolis Center for Health Policy. “Combined with Sally Okun’s lasting contributions, a thoughtful transition plan, and a strong team, CTTI is uniquely positioned—at critical time—to identify and support innovative strategies to speed the development of better clinical evidence to help more patients at a lower cost.” 

Serving as CTTI’s Director of Strategic Programs since January 2022, Hanger has collaborated on strategic initiatives related to the organization’s Transforming Trials 2030 vision and led the early-stage activities of CTTI’s newest project, Measuring Trials Transformation. Prior to CTTI, she spent three years as an independent consultant advising health technology companies and innovators on the development of new products. Previously, she served as vice president of the online patient research network PatientsLikeMe (PLM), where she led programs utilizing patient-generated health data in life sciences and regulatory settings. Hanger’s earlier work provided consulting and advisory services to leading pharma, biotech companies, and professional societies to create more effective research strategies. She also held positions within the Health Outcomes Group at Memorial Sloan Kettering Cancer Center and the Congressional Budget Office. 

“I am excited and honored to lead CTTI at such an exciting moment in its trajectory,” Hanger said. “We have terrific members, partners, and a highly adaptive and talented team, all of whom are eager to drive change across the clinical trials enterprise. We will continue to lean into the transformation part of our directive by deepening our implementation resources, focusing on enterprise-wide measurement, and supporting the FDA as they anticipate and facilitate the evolution of trials with modernized designs, data, and capabilities.”  

“I know I speak for the entire CTTI team in celebrating Morgan’s promotion to the Executive Director position,” said Sally Okun, CTTI’s current Executive Director, who is retiring at the end of this year. “Over the past two years, Morgan’s unique combination of innovative thinking, operational skills, and inclusive engagement have guided the development of an impactful and measurable strategic plan. It is a rare privilege to have a person of Morgan’s caliber so well positioned to seamlessly continue advancing CTTI towards its transformational 2030 vision.”  

Hanger, who assumes her new role in January 2024, will work closely over the next several months with Okun to ensure a smooth transition. Both Hanger and Okun are working with Executive Committee leadership – Chair Mark McClellan, Duke Co-chair John Alexander, and FDA Co-chair Khair ElZarrad – on a thoughtful succession plan that ensures the highest level of team and organizational integrity. In addition, the CTTI team is actively involved in this transition process – one that considers their voices and reflects their perspectives about the next generation of CTTI leadership and its strategy moving forward.  

New CTTI Project to Develop Common Framework to Assess Progress Towards TT2030 Vision

Posted on by Hannah Faulkner

Clinical trials are critical components of the evidence generating system in research. Launched in 2021, CTTI’s Transforming Trials 2030 vision outlines five pillars for how clinical trials should be performed by 2030. This vision establishes that clinical trials need to be patient centered and easily accessible, fully integrated into health processes, designed with a quality approach, maximally leveraging all available data, and improving population health. Currently, the TT2030 vision lacks metrics to demonstrate progress towards the vision’s five central goals. The Measuring Trials Transformation (MTT) Project will develop a common framework to evaluate and assess the progress made towards achieving the five main goals of the TT2030 vision, a framework that can be used to share accountability across the clinical trials enterprise.  

After launching the TT2030 vision, CTTI conducted concept elicitation interviews to develop key concepts metrics should address within each pillar. In 2022 and early 2023, CTTI conducted surveys of experts to assess the value of individual metrics for assessing progress towards the vision. 

To deploy a set of relevant metrics, CTTI will utilize a variety of iterative strategies, including interviews with key stakeholders on their experiences with each pillar and ideas for related metrics, expert surveys on draft measures for each pillar, and an online public forum on the measurement framework. The selected metrics will be further refined by integrating public comment, expert input, and project team feedback and discussions. CTTI will perform a case study using the framework of metrics to measure progress towards the TT2030 vision by collecting and reporting an initial set of metrics using recent clinical trials.   

CTTI understands that some goals of the TT2030 vision will be achieved sooner than others, and so the framework created by the MTT Project will establish key milestones to assess progress made by the program over time. CTTI will use this vision to guide their priorities, and they will encourage others to do the same, facilitating accountability across the entire clinical trials industry.  

The Metrics Framework is currently open for public comment until mid-October 2023. Please view the dashboard and provide your suggestions and feedback here. 

FDA, CTTI Convening Virtual Public Workshop on Enhancing Clinical Study Diversity

Posted on by Hannah Faulkner

The U.S. Food and Drug Administration (FDA), in collaboration with the Clinical Trials Transformation Initiative (CTTI), is convening a virtual public workshop to solicit input on increasing the enrollment of historically underrepresented populations in clinical studies and encouraging clinical study participation that reflects the prevalence of the disease or condition among demographic subgroups.  

The free two-day virtual public workshop will be held on November 29 and 30, 2023, from 10 a.m. – 2 p.m. EST on both days. Registration for the workshop is now open and an agenda for the workshop can be viewed here. 

We are inviting those who register to submit questions for our speakers and panelists in advance of the meeting. Please click here to submit your questions.

Representatives from academia, clinical research organizations, drug sponsors, medical device sponsors, patients, and other interested parties will share their experiences and approaches for increasing enrollment and encouraging participation of historically underrepresented populations in clinical studies. 

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

CTTI Executive Director Sally Okun Announces Retirement

Posted on by Hannah Faulkner

I wanted to let you know that after much consideration and reflection I am retiring from my position as Executive Director of the Clinical Trials Transformation Initiative by the end of 2023.  

My time at CTTI has been incredibly rewarding both professionally and personally and my decision to retire was not an easy one. I am grateful for the support, opportunities, and camaraderie I have experienced throughout my time here. As I prepare to embark on a new chapter after five decades in healthcare, I feel a mixture of emotions, including excitement, as I contemplate the future for me and my loved ones. 

When I arrived at CTTI in October of 2021, we were navigating our way into a post pandemic world and changing clinical trial ecosystem. Our CTTI team and members stepped up to meet these challenges and opportunities with creativity, curiosity, and resilience. It has been a privilege to work alongside this talented team and the many dedicated professionals, patients, and caregivers from across our membership who demonstrate their commitment to CTTI’s mission and bold vision each day. 

Over the next several months, I am committed to ensuring a smooth transition of my responsibilities to my successor. I’m working closely with Duke and CTTI’s Executive Committee leadership – Chair Mark McClellan, Duke Co-chair John Alexander, and FDA Co-chair Khair ElZarrad – on a thoughtful and mindful succession plan that ensures the highest level of team and organizational integrity.  

In addition, the CTTI team is actively involved in developing a transition process that includes their voices and reflects their perspectives about the next generation of leadership for our organization. The job posting for the Executive Director of CTTI has posted to Duke’s career webpage. I welcome any thoughts, ideas, and suggestions you wish to share as we begin this process. 

And finally, I want to express my deepest gratitude to our CTTI community for making my experience with CTTI unforgettable. It gives me great pride to have been a part of CTTI’s work and achievements during my tenure. Our exciting and important work continues this fall and rest assured we won’t miss a beat with this transition. 

FDA, CTTI Convening Virtual Public Workshop to Discuss FDA Emergency Recommendations to Mitigate Clinical Study Disruptions

Posted on by Hannah Faulkner

The Food and Drug Administration (FDA), in collaboration with the Clinical Trials Transformation Initiative (CTTI), is convening a virtual public meeting on Oct. 18 and 19, 2023 to discuss recommendations provided by the FDA during the COVID-19 public health emergency (PHE) to mitigate disruption of clinical studies, including recommendations detailed in the guidance entitled “Conduct of Clinical Trials of Medical Products During the COVID-19 Public Health Emergency, Guidance for Industry, Investigators, and Institutional Review Boards.”

Registration for the meeting is now open.

We are inviting those who register to submit questions for our speakers and panelists in advance of the meeting. Please click here to submit your questions.

The meeting will also include discussions with representatives from the FDA, pharmaceutical and medical device industries, academia, research study teams, patients, and patient advocacy groups, and other federal agencies, who will share the experiences, best practices, and approaches they used to effectively navigate disruptions to clinical studies during the COVID-19 PHE. An agenda for the meeting can be viewed here.

The meeting fulfills a requirement under section 3605 of the Food and Drug Omnibus Reform Act of 2022 (FDORA) and will discuss potential strategies for advanced planning to mitigate clinical study disruptions in the future.

The free two-day virtual public meeting will be held on Oct. 18 and 19 from 10 a.m. – 1:30 p.m. ET on both days.

Now Accepting Applications for FDA and CTTI Patient Engagement Collaborative (PEC)

Posted on by Hannah Faulkner

The FDA and CTTI are currently accepting applications from patient advocates interested in becoming members of the Patient Engagement Collaborative (PEC). The PEC is an ongoing, shared forum in which the patient community (PEC members), FDA, and CTTI discuss a variety of topics such as improving communication, education, and patient engagement related to medical product regulation.

Applicants will be selected based on their ability to meaningfully contribute to the PEC, represent and express the patient voice for their constituency, work in a constructive manner with involved stakeholders, and understand and navigate the clinical research system.

Successful applicants will include:

  • Patients who have personal disease experience
  • Caregivers who directly support patients (e.g., a family member or friend) and have personal disease experience through this caregiver role
  • Representatives from patient groups who, through their role in the patient group, have direct or indirect disease experience

PEC members participate in two to four virtual meetings per year. Other meetings may be organized, as needed.

The following PDF format documents are required to apply and must be submitted at the same time:

  • A current and complete one- to two-page resume or bio that summarizes your patient advocacy experience and related activities; and
  • A one-page professional letter of endorsement from a patient group with which you have worked closely on activities that are relevant to the PEC

A maximum of 75 applicants will be considered for PEC membership and up to 8 members will be selected. Interested applicants are encouraged to complete and submit the online form starting at 10:00 a.m. EDT on July 14, 2023. This announcement is open to receive a maximum of 75 applications.

Applications will be accepted until 11:59 p.m. Eastern Time on August 14, 2023, or until 75 complete applications are received, whichever happens first.

Those who are unable to apply electronically are encouraged to call FDA Patient Affairs at 301-796-8460 to arrange for a mail submission.

Please review the related Federal Register Notice for important information about the application process.

CTTI Publication Investigates Challenges and Solutions Surrounding Digitally Derived Endpoint Acceptance

Posted on by Hannah Faulkner

A new CTTI publication, published in Digital Biomarkers, investigates the challenges sponsors encounter when using digitally derived endpoints and offers potential solutions. Digital health technologies – including mobile apps, smart devices, sensors, and wearables – can capture robust data from participants’ daily lives. These digital tools allow researchers to collect data for novel endpoints that can provide a broader view of health and treatment effects using measures that matter to patients. Despite these benefits to clinical trial quality and efficiency, digitally derived endpoints are still underutilized as primary evidence in regulatory submissions.

To evaluate the barriers and challenges associated with digitally derived endpoints to support labeling claims, CTTI interviewed 20 sponsor representatives from 10 different organizations representing 11 individual clinical trials. During these interviews, conducted between November 2020 and March 2021, sponsor representatives were asked about their experiences related to digitally derived endpoints, their interactions with regulators, and the challenges they encountered. Based on these interviews, CTTI identified five key challenges to incorporating digitally derived endpoints in clinical trials:

  1. a lack of regulatory guidance specific to digitally derived endpoints;
  2. a qualification process for new clinical outcomes that is impractical for most industry sponsors;
  3. a lack of comparable clinical endpoints to validate novel digitally derived endpoints;
  4. a lack of validated DHTs and algorithms for a concept of interest; and
  5. a lack of operational support from technology vendors.

CTTI shared these interview findings with the U.S. Food & Drug Administration (FDA) and the European Medicines Agency (EMA) and during a multi-stakeholder expert meeting. Through these discussions, CTTI drafted and refined a set of recommendations and tools for developing novel digitally derived endpoints as part of the Digital Health Trials Hub. These resources provide a robust toolkit for sponsors, investigators, and operational partners navigating the regulatory landscape around digitally derived endpoints.

Recording Now Available: CTTI Webinar Unveiling New Recommendations on Increasing Diversity in Clinical Trials

Posted on by Hannah Faulkner

A recording of CTTI’s May 18 webinar unveiling the new recommendations on increasing diversity in clinical trials is now available. 

The one-hour webinar includes a welcome from Sally Okun, CTTI; opening remarks from Richardae Araojo, U.S. Food and Drug Administration (FDA); a project overview from Luther Clark, Merck; a maturity model overview from Dawn Corbett, NIH; and a panel discussion moderated by Sara Calvert, CTTI. The panel discussion focused on stakeholder perspectives related to the integration of the of the new diversity recommendations and included Ruma Bhagat, Genentech-a member of the Roche Group; Tesheia Johnson, Yale; Jane Williams, Syneos Health; and Glendon Zinser, Susan G. Komen. 

The goal of creating these diversity recommendations is to increase the inclusion and adequate representation of women and historically underrepresented racial and ethnic groups in clinical trials to facilitate more accurate and generalizable trial results by enhancing and expanding our understanding of the safety and efficacy of investigational medical products. These recommendations were developed in collaboration with experts and key stakeholders from across the clinical trials enterprise using CTTI’s five-step methodology designed to ensure they are actionable, evidence-based, and consensus-driven. The first phase involved gathering input through qualitative, in-depth interviews with senior-level leaders at organizations conducting clinical trials to gather perspectives on strategies to support diversity and inclusion in clinical research. The recommendations were drafted and refined with input from a multi-stakeholder project team and through a 2-day Expert Meeting. 

View the slide deck to read more. 

 

CTTI to Launch New Diversity Recommendations at Free Public Webinar

Posted on by Hannah Faulkner

CTTI will host a free public webinar on Thursday, May 18 at 12:00 p.m. EDT to unveil new recommendations for increasing diversity in clinical trials.  

The webinar will include a welcome from Sally Okun, CTTI; opening remarks from Richardae Araojo, U.S. Food and Drug Administration (FDA); a project overview from Luther Clark, Merck; a maturity model overview from Dawn Corbett, NIH; and a panel discussion that will focus on stakeholder perspectives related to the integration of the new recommendations. 

The inclusion and adequate representation of women and historically underrepresented racial and ethnic groups in clinical trials leads to more accurate and generalizable trial results by enhancing and expanding our understanding of the safety and efficacy of investigational medical products. In addition, inclusion of all the populations who are affected by a condition can improve access to innovative and potentially life-extending and life-improving therapies, develop trust in clinical trial results, and facilitate uptake if the medical product is approved. 

As part of the Diversity Project, experts and key stakeholders from across the clinical trials enterprise developed the recommendations following CTTI’s five-step methodology designed to ensure they are actionable, evidence-based, and consensus-driven. The CTTI recommendations and supporting maturity model seek to build on the growing recognized need for long-term, transformative strategies that are rooted in a deep organizational commitment to developing clinical trial research infrastructure that is more responsive to the needs of historically underrepresented populations. 

Register for the free one-hour webinar. 

CTTI Holds Meeting to Discuss Engaging Stakeholders in Trial Design

Posted on by Hannah Faulkner

The Clinical Trials Transformation Initiative (CTTI) held a multi-stakeholder Expert Meeting on April 4 to discuss high-value approaches and situation-specific considerations for meaningful engagement of internal and external stakeholders in clinical trial design and implementation. Engaging all stakeholders during the earliest stages of study development is an important feature of quality by design (QbD). Aligned with CTTI’s QbD approach, the Engaging Stakeholders in Trial Design Project team is developing an engagement roadmap and recommendations to enable clinical trial designers to meaningfully and effectively engage all stakeholders across the trial design process. The project team is also collating resources surrounding the engagement of stakeholders to increase the efficiency of trial design to benefit patients faster. 

Experts from academia, clinical research organizations, patient advocacy groups, regulatory agencies, and the pharmaceutical industry discussed the challenges and opportunities, key strategies, and metrics for assessing holistic stakeholder engagement across the continuum of clinical trials. The following key themes were emphasized during the meeting: 

  • It is important to engage key stakeholders – including patients, site staff, and regulatory agencies – very early in the design of clinical trials. When planning study timelines, identify all internal and external stakeholders and the appropriate time and approach to solicit their input. 
  • Stakeholder engagement should be an iterative process throughout the life cycle of clinical trials. Internal and external stakeholders should be engaged, as appropriate, from the beginning of clinical trial design through the dissemination of results. 
  • Bring stakeholders and functional groups together to identify gaps between teams and brainstorm solutions to increase the quality and efficiency of trials. Effective communication and collaboration across all stakeholder groups is crucial to create a community around designing high-quality studies that meet the needs of patients and that generate reliable evidence with fewer amendments.  
  • Advanced methodologies and tools, such as artificial intelligence and machine learning, can help study designers develop innovative, high-quality trials and streamline processes. With databases of real-world and clinical trial data, artificial intelligence and machine learning can be used to inform the design of trials, explore potential treatments for patient subgroups, assess feasibility of enrollment, and identify sites. 
  • A collection of resources for designing clinical trials, including recommendations on how and when to meaningfully engage all stakeholders, is needed to help study designers plan innovative clinical trials more efficiently and in alignment with regulatory guidance.