Formats
CTTI to Launch New Online Digital Health Trials Hub
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
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
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
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.