CTTI News

Recent CTTI Publication Explores Educational Strategies for Increasing Use of Anticoagulants Among AFib Patients

Posted on by Hannah Faulkner

A new CTTI publication from collaborators including CTTI investigates the impact of educational mailings in increasing the use of oral blood thinners among patients with atrial fibrillation (AFib). For many of these patients, use of blood thinners can reduce their stroke risk by about 70%. Despite current guideline recommendations, only about half of eligible patients with AFib are routinely taking blood thinners, and patient interviews have revealed that patients are undereducated about stroke risk and the potential benefits of preventative blood thinner use. To explore solutions to this educational gap, the IMplementation of a randomized controlled trial to imProve treatment with oral AntiCoagulanTs in patients with Atrial Fibrillation (IMPACT-AFib) identified and sent educational mailings to a subset of eligible patients enrolled in health plans that participate in the FDA’s Sentinel System. The resulting paper, published in JAMA Network Open, found that these mailings were only minimally successful in increasing blood thinner use among AFib patients. These results indicate that more intensive educational interventions may be needed to address this problem. 

This trial was the first ever to leverage the FDA-Catalyst System, which combines data from interactions with patients and/or providers with data from the Sentinel Infrastructure. The collaboration included Aetna, Duke Clinical Research Institute, the Harvard Pilgrim Health Care Institute’s Department of Population Medicine, Harvard Pilgrim Health Care, HealthCore Anthem, Humana, Optum, and the FDA.  

CTTI Publication Investigates Use of Preventive Statins among Patients with Cardiovascular Disease

Posted on by Hannah Faulkner

A new CTTI publication, published in the Journal of the American College of Cardiology, investigates the use of preventive, high-intensity statins among patients diagnosed with atherosclerotic cardiovascular disease (ASCVD). The study, which used pharmacy and medical claims data from a commercial health plan, found substantial underuse of statins among insured ASCVD patients. Most notably, younger patients and women were among those less likely to be prescribed any statin. In those prescribed a statin, women and older patients were less likely to receive high-intensity statins. This paper was based on exploratory work done by CTTI with Duke and HealthCore as background to inform a potential randomized intervention to improve the use of guideline recommended high-intensity statins. 

Recording Now Available: CTTI Webinar Introducing New Digital Health Trials Hub

Posted on by Hannah Faulkner

A recording of CTTI’s April 6 public webinar introducing the new Digital Health Trials Hub is now available. The one-hour webinar includes presentations from Megan Doyle, Amgen, and Jörg Goldhahn, ETH Zurich; a stakeholder panel featuring Phil Green, CTTI, Elizabeth Kunkoski, FDA, Jeremy Wyatt, ActiGraph, and Reem Yunis, Medable; and a Q&A session moderated by Lindsay Kehoe, CTTI.

CTTI’s Digital Health Trials Hub features new and enhanced resources to help sponsors, investigators, CROs, and technology providers design and run quality, patient-centered clinical trials. The new Hub resources include significantly updated recommendations, revised reference documents, a Question Bank for Identifying Meaningful Outcome Measures, and a Process Map for the development of digitally derived endpoints. These resources are the culmination of CTTI’s 2021 Digital Health Trials work, which highlighted importance of early stakeholder engagement and flexible, tailored approaches to trial design and conduct.

The materials in the new Hub are broken down into six core areas of Digital Health Trial design and conduct:

  • Developing Novel Endpoints
  • Planning Decentralized Trials
  • Selecting & Testing Digital Health Technology
  • Managing Data
  • Interacting with Regulators
  • Supporting Sites

View the slide deck to read more.

 

 

CTTI to Launch New Online Digital Health Trials Hub

Posted on by Hannah Faulkner

CTTI will host a public webinar on Wed., Apr. 6 to introduce a new online Digital Health Trials Hub featuring enhanced recommendations and additional resources. 

“This updated and expanded resource drives CTTI’s bold Transforming Trials 2030 vision by helping sponsors, investigators, CROs and technology providers design and run clinical trials that are patient-centered, easily accessible, and designed with a quality approach,” said CTTI Executive Director Sally Okun. 

The new Hub combines resources that have been restructured from CTTI’s four existing Digital Health Trials projects, completed from 2017 to 2019, along with improvements and new work from two project teams, Decentralized Clinical Trials Updates and Novel Endpoints Acceptance. By creating the Hub, CTTI’s aim is to make the most relevant information more useful and accessible for those in the clinical trials enterprise who are designing and running patient-centered trials. 

Key enhancements and additions made to the Hub include significantly updated recommendations, revised reference documents, and two new resources – the Question Bank for Identifying Meaningful Outcome Measures and a Process Map for use of a digitally-derived endpoint in an individual drug development pathway. These enhancements are the culmination of CTTI’s 2021 Digital Health Trials work that highlighted the importance of early stakeholder engagement, flexibility and tailored approaches to trial design and conduct, and flexible support of sites. 

The free one-hour webinar, which includes presentations from Megan Doyle of Amgen and Jörg Goldhahn of ETH Zurich, will begin at 11:00am EDT and registration is available online on CTTI’s website. 

New CTTI Project Aims to Promote the Use of Disease Progression Modeling to Advance Trial Design and Decision Making

Posted on by Hannah Faulkner

Modeling and simulations are powerful tools that can be leveraged to inform clinical trial design, support regulatory decision making, and accelerate the process of bringing treatments to patients. Despite the benefits of these methods, their use is still not widely accepted among sponsors, investigators, and regulators. Recently, there has been growing interest across the clinical trials ecosystem in advancing the use of disease progression modeling to improve clinical trial quality and efficiency and inform regulatory decision making. Disease progression modeling leverages data from a variety of sources, improving trial diversity and combining many different models to help inform decision making. 

To promote these methods, CTTI has started a new project engaging a variety of stakeholders and experts in the development of recommendations and resources for the application of disease progression modeling in clinical trials. Through this project, CTTI will generate case studies detailing successful applications of disease progression modeling, a framework for the execution of disease progression modeling in clinical trials, a set of recommendations for the implementation of disease progression modeling in clinical trials, and a review paper detailing relevant disease progression modeling applications. This project aims to improve trial and clinical development efficiency by increasing the recognition, value, and consistent use of disease progression modeling. CTTI’s work in this area will also help to advance the broader application of modeling and simulation for trial design and regulatory decision making. 

To generate recommendations and resources supporting the application of disease progression modeling in clinical trials, CTTI will utilize a variety of iterative evidence generating strategies—including a scoping review assessing the landscape of disease progression modeling applications and an expert meeting discussing the barriers to disease progression modeling application and avenues for advancement. 

Through this work, CTTI will create recommendations and resources for designing clinical trials with a quality approach that maximally leverages available data—in alignment with CTTI’s Transforming Trials 2030 vision.

 

CTTI Announces Leadership Appointments & Promotions

Posted on by Hannah Faulkner

Today CTTI announced the appointments and promotions of a new leadership team including Sara Calvert as Director of Projects, Morgan Hanger as Director of Strategic Programs and Zachary Hallinan as Director of Strategic Engagement & Communications. In addition, team members Rae Holliday, Strategic Communications Manager, and Karisa Merrill, Strategic Engagement Manager, were promoted to management positions; Lindsay Kehoe was promoted to Senior Project Manager; and Erin Bland was promoted to Engagement & Communications Specialist. 

“In announcing these leadership appointments, I am proud that CTTI is able to tap into the talent, experience and passion inside CTTI and promote from within our organization,” said Sally Okun, CTTI’s Executive Director. “As we continue to drive positive change across the clinical trials enterprise, consistent performance will require a strong, diverse and talented team. These leaders, as well as our entire staff, are well prepared to lead CTTI’s most ambitious project to date, the bold Transforming Trials 2030 vision. I am confident that these appointments and promotions better position us to achieve our strategic priorities in the months and years ahead.” 

The following promotions and appointments, which collectively represent more than 25 years of service to CTTI, have gone into effect between December 2021 – March 2022: 

  • Erin Bland, Engagement & Communications Specialist, provides design and management of the engagement team’s communication strategies. She participates in providing input for all new and ongoing projects to contribute to the growth and support of CTTI’s goals. She also manages logistics for CTTI member events and member communications. 
  • Sara Calvert, Director of Projects, is currently responsible for senior operational leadership and oversight for the core activities of the CTTI projects group. She collaboratively develops and implements strategies to support CTTI’s project managers and multistakeholder project teams as they develop solutions to improve clinical trials, and ensures the alignment of project objectives with CTTI’s mission, vision, and goals. 
  • Zachary Hallinan, Director of Strategic Engagement & Communications, provides senior operational leadership and oversight for CTTI’s strategic communications and engagement group, including collaboratively developing and implementing strategies and operational plans to support effective external communication and engagement with CTTI’s approximately 80 member organizations and the broader clinical trials enterprise. 
  • Morgan Hanger, Director of Strategic Programs is leading a new initiative to develop a parsimonious set of metrics to assess, monitor, and analyze the progress of the clinical trial enterprise towards CTTI’s Transforming Trials 2030 vision, as well as advising on CTTI strategy and operations. 
  • Rae Holliday, Strategic Communications Manager, is currently responsible for cultivating CTTI’s public profile through brand strategy, content development, events, media relations, and thought leadership. She is leading the development of the communications strategy for CTTI’s Transforming Trials 2030 vision in collaboration with CTTI’s communications team, DCRI writers and designers and CTTI’s agency of record. 
  • Lindsay Kehoe, Senior Project Manager, manages the development and implementation of CTTI projects, as well as represents CTTI activities to internal and external audiences. She is reminded daily of the power of collaboration and innovative thinking as she convenes stakeholders around Disease Progression Modeling, Embedding Trials into Health Care Settings, advancing Digital Health Trials, and accelerates progress towards the Transforming Trials 2030 vision. 
  • Karisa Merrill, Strategic Engagement Manager, currently manages CTTI’s membership and engagement team. She also plans, develops, and implements strategic initiatives that support the implementation of systematic improvement processes, drive adoption of CTTI’s recommendations and resources, and demonstrate the impact of CTTI’s work on the transformation of clinical trials.

New CTTI Project Aims to Engage All Stakeholders in Clinical Trial Design

Posted on by Hannah Faulkner

Engaging patients and all stakeholders from the earliest stages of trial design is increasingly recognized as fundamental to planning and conducting high quality clinical trials. Yet important gaps remain, including a lack of comprehensive resources for engaging all stakeholders and a unifying framework, especially one tied to regulatory guidance.

To address these gaps, CTTI is starting work on a new project that will result in an engagement roadmap, multi-stakeholder recommendations, and supporting resources for effectively and efficiently engaging all stakeholders in the design of clinical trials. This project aims to identify:

  • Specific opportunities and high-value approaches/methods/tools for study designers to engage with internal and external stakeholders across the clinical trial design and planning process.
  • Situation-specific considerations for ensuring engagement is appropriately equitable, effective, and feasible.

In carrying out this work, CTTI will conduct iterative design and evidence gathering activities, including a landscape scan, user-testing and formal research aimed at reaching consensus across stakeholders on suggested engagement, and one or more multi-stakeholder expert meetings to review and synthesize findings.

By taking a multifaceted approach, CTTI will create resources that will enable clinical trial designers to collectively and coherently use various existing methods to engage all stakeholders across the trial design process – leading to more efficient, higher quality research in alignment with CTTI’s vision for clinical trials by 2030.

Happy Holidays from the Clinical Trials Transformation Initiative

Posted on by Hannah Faulkner

Happy Holidays from CTTICTTI ushered in 2021 with a new vision for Transforming Trials 2030 – one that requires cross-system collaboration from the entire research and healthcare community to create true and lasting change for better clinical trials by 2030.

On behalf of everyone at CTTI, thank you for joining us on this ambitious journey this year. Your contributions to pushing the boundaries for what can be done in clinical research and your dedication to creating improvements across the clinical trials community are truly making an impact. We are grateful for the opportunity to work with you and are proud to have your support.

Some of the accomplishments you have made possible in 2021 include:

  • Sharing best practices and learnings from across the clinical trials community by:
    • Launching our new Building Better Trials: Case Study Exchange, featuring more than 40 case studies on best practices and examples of CTTI’s work in action;
    • Collaborating with the Duke-Margolis Center for Health Policy and FasterCures on a public summit on using master protocols in COVID-19 trials, and with the Digital Medicine Society (DiMe) and TransCelerate on a three-part webinar series on novel digital endpoints and;
    • Hosting a public webinar on COVID-19 treatment trials with clinical research experts.

As we look to 2022 under the leadership of our passionate new leader, Executive Director Sally Okun, we are excited to celebrate 15 years of increasing the quality and efficiency of clinical trials through the future-facing lens of our 2030 vision. This ambitious pursuit is the ultimate challenge, but also presents the biggest opportunity and reward.

As Socrates said, “The secret of change is to focus all of your energy, not on fighting the old, but on building the new.”

We look forward to “building the new” with you in 2022 and to making great strides toward achieving the audacious goal of transforming trials by 2030.

Best wishes for health and happiness to you and your families over this festive season and in the new year!

 

CTTI Holds Meeting to Discuss the Systemic Changes Needed to Increase Diversity in Clinical Trials

Posted on by Hannah Faulkner

The Clinical Trials Transformation Initiative (CTTI) held a two-day multi-stakeholder expert meeting on Oct. 12 & 21 to discuss the systemic changes needed to ensure that U.S. clinical trials better meet the needs of diverse populations, including racial minorities, ethnic minorities, and women. At the meeting, leaders and key stakeholders from across the clinical trials ecosystem participated in an engaging forum, informative discussions, and lively breakout sessions that shed more light on new solutions for sharing information and ensuring sufficient resource allocation to diversity, equity, and inclusion initiatives.

Meeting attendees also identified some important themes and identified opportunities to increase diversity in clinical trials:

  • The benefits are indisputable. Including a diverse population in clinical trials improves the quality of science, enhances patient trust, increases patient recruitment and retention, and improves clinical care for all patients.
  • A culture shift is needed. Organizations need to ingrain diversity, equity, and inclusion initiatives into their portfolio-level strategy and within their overall mission. They should foster bi-directional community partnerships and directly engage patients in the design and planning of clinical trials and diversity efforts from the very beginning.
  • This is a full group effort. Increasing diversity in clinical trials is a multi-stakeholder effort that will take all groups working together to achieve goals of clinical trial populations representing the populations who are affected by disease.
  • There is important work ahead of us. Meeting attendees provided feedback on CTTI’s draft maturity model, helping to create a better public resource. Suggested additions included a focus on values and guidelines that are generalizable to a wide variety of stakeholders, not just industry stakeholders, and more guidance on how organizations can measure their progress through the maturity model.

CTTI is now using these findings – along with other research results and multi-stakeholder discussions – to develop recommendations and resources for release in early 2022. The project team may host additional webinars focusing on case studies and implementation of resources.

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 will meet with the FDA several times a year to discuss topics such as communication, transparency, and the best ways for patients to participate in the FDA’s regulatory discussions about medical products. Those selected to the PEC are expected to serve for two years.

The eight new representatives are:

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

The representatives were selected from more than 100 applications received in response to a Federal Register notice published in July 2021. 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 delighted to welcome the new members to the PEC and we extend our deepest thanks to those outgoing members for their important service and contributions,” said Sally Okun, CTTI’s executive director. “As CTTI works to advance our vision of Transforming Trials 2030, we anticipate that discussions with the PEC can help us identify opportunities to achieve our first pillar, in particular: ‘to make clinical trials patient-centric and easily accessible’. We can only accomplish this if we are on the journey together with patients.”

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 Office of Patient Affairs, which is dedicated to providing an inviting, welcoming and meaningful experience for patient communities to engage with the FDA.

“Understanding patients’ experiences is critical to informing medical product regulation and helping ensure that safe, effective and innovative medical products are available and meet the needs of patients as best as possible for improved quality of life. Learning from patients through the PEC helps the agency uphold its public health mission,” 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 and enhance the clinical trials enterprise. The next cohort of PEC members will identify topics to focus on. Previous topics have included: creating new ways to collaborate with patient communities; making patient engagement more systematic; improving transparency through education and outreach; 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:

  • Dawn Aldrich
  • Christine Brown
  • Jeffrey Goldstein
  • Melissa Hogan
  • Nancy Lenfestey
  • Stephanie Monroe
  • Theresa Strong
  • Dave White

The PEC has worked tirelessly to incorporate the patient voice in the FDA’s medical product regulatory programs. For example, the PEC has:

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.