Adoption of Decentralization: Are Our Perceptions Holding Us Back?
Digital Health Trials
CTTI Launches New Online Digital Health Trials Hub
CTTI Project: Developing Novel Endpoints, Planning Decentralized Trials
Today the Clinical Trials Transformation Initiative (CTTI) announced a new online Digital Health Trials Hub featuring enhanced recommendations and additional resources.
CTTI’s Digital Health Trials Hub: Revised Recommendations and New Resources for DCTs and Novel Endpoints
CTTI Project: Developing Novel Endpoints and Planning Decentralized Trials
Webinar Presenters:
- Megan Doyle, Amgen
- Jorg Goldhahn, ETH Zurich
- Phil Green, CTTI
- Lindsay Kehoe, CTTI
- Elizabeth Kunkoski, FDA
- Jeremy Wyatt, ActiGraph
- Reem Yunis, Medable
Webinar Resources:
Next Steps for Obtaining Novel Endpoint Reliability & Acceptance
CTTI Project: Developing Novel Endpoints
Webinar Presenters:
- Michelle Crouthamel, AbbVie
- Jennifer Goldsack, DiMe
- Lindsay Kehoe, CTTI
- Alicia Staley, Medidata
Webinar Resources:
Decentralized Clinical Trials Update Expert Meeting
AUGUST 25, 2021 TO AUGUST 26, 2021
CTTI Project: Supporting Decentralized Trial Approaches
Meeting Objectives:
In order to update CTTI’s existing decentralized clinical trials (DCT)* recommendations, this expert meeting aimed to:
- Collect recent knowledge and insights – both what works and what doesn’t – from operationalizing DCT solutions (i.e., remote and virtual visits, using local labs and healthcare providers, and direct-to-participant shipping)
- Understand current practices for incorporating DCT solutions in clinical trials, including considerations for protocol design and safety monitoring
- Identify opportunities to increase adoption of DCT solutions moving forward
*For the purposes of this meeting, DCTs were defined as those executed through telemedicine and mobile/local healthcare providers, using procedures that vary from the traditional clinical trial model (e.g., the investigational medical product is shipped directly to the trial participant).
Meeting Location:
Virtual Meeting
The views and opinions expressed in these presentations are those of the individual presenter and should not be attributed to the Clinical Trials Transformation Initiative, or any organization with which the presenter is employed or affiliated.
Obtaining Novel Endpoint Reliability and Acceptance Expert Meeting
JULY 27, 2021 TO JULY 28, 2021
CTTI Project: Developing Novel Endpoints
Meeting Objectives:
- Identify the barriers and discuss solutions to the adoption of DHT-derived endpoints into pivotal trials
- Discuss the data needed to prove that a DHT-derived endpoint is ready for a pivotal trial
- Explore how collaboration and other new efforts can advance the adoption of DHT-derived endpoints
Meeting Location:
Virtual Meeting
Meeting Materials:
Day 1
- Session I: DHT-Derived Novel Endpoint Development: Current Landscape
- Session II: DHT-Derived Endpoints in Trials: The Reality vs. the Idea
- Mentimeter Results - Day 1
Day 2
The views and opinions expressed in these presentations are those of the individual presenter and should not be attributed to the Clinical Trials Transformation Initiative, or any organization with which the presenter is employed or affiliated.
Adapting Clinical Trials during COVID-19: Solutions for Switching to Remote and Virtual Visits
CTTI Project: Clinical Trials Issues Related to COVID-19
Webinar Presenters:
- Pamela Tenaerts (Clinical Trials Transformation Initiative)
- Jacqueline Corrigan-Curay (FDA, CDER)
- Laura Cooke (Amgen)
- Bray Patrick-Lake (Evidation Health, Inc.)
- Ramya Thota (Intermountain Healthcare, ASCO)