Adoption of Decentralization: Are Our Perceptions Holding Us Back?
Planning Decentralized Trials
Recording Now Available: CTTI Webinar Introducing New Digital Health Trials Hub
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
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.
CTTI Holds Meeting to Refresh and Enhance Decentralized Clinical Trials Recommendations
The Clinical Trials Transformation Initiative (CTTI) held a two-day multi-stakeholder expert meeting on Aug. 25-26 to discuss best practices on conducting research in remote and virtual settings, including lessons learned from the COVID-19 pandemic. The insights gathered will be used to refresh CTTI’s 2018 Decentralized Clinical Trials (DCT) recommendations and ensure that they offer the most current information for planning and operationalizing DCT solutions (i.e., remote and virtual visits, using local labs and healthcare providers, and direct-to-participant shipping).
During the meeting, relevant experts and key stakeholders—including investigators, patients, regulators, technology experts, sponsor representatives, and other groups—CTTI and attendees exchanged knowledge, insights, and current solutions for using DCT solutions in clinical trials.
They also identified some important themes and identified opportunities to increase adoption of DCT solutions moving forward:
- Design with Purpose. The design of DCTs must prioritize patient safety and data quality. DCT elements should only be incorporated into study design where they are appropriate to the purpose of the study.
- Engage Everyone. It’s important to engage all stakeholders in DCT protocol design and implementation.
- Think Ahead, Early On. Careful planning and consideration from the earliest stages of study and program design is essential.
- Invest in Quality. DCTs are often not the cheapest or easiest solution, but they can be the most impactful in terms of making trials more patient-centered and getting the best data.
- Where to Focus Next. Communication, collaboration, and regulatory guidance are critical for broader adoption of DCT solutions.
CTTI is now updating its recommendations and will make them available by early 2022 to help accelerate the adoption of DCT solutions in clinical trials going forward.