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CTTI

Clinical Trials Transformation Initiative

Leveraging All Data

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.

Download Press Release

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:

Download PowerPoint slideset
Mentimeter Results

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:

Download PowerPoint slideset

Regulatory Engagement Opportunities when Developing Digitally Derived Endpoints

Posted on April 6, 2022February 5, 2025 by Hannah Faulkner

Regulatory Engagement Opportunities when Developing Digitally Derived Endpoints

Posted in Developing Novel Endpoints, Innovative Trials, Interacting with Regulators, Interacting with Regulators, Leveraging All Data, Regulatory Submissions + Approvals, Resources, Study Design

Question Bank for Identifying Meaningful Outcome Measures

Posted on April 5, 2022January 31, 2025 by Hannah Faulkner

Question Bank for Identifying Meaningful Outcome Measures

Posted in Developing Novel Endpoints, Innovative Trials, Leveraging All Data, Novel Endpoints, Regulatory Submissions + Approvals, Resources, Study Design, Study Operations

Preparing a Digitally-derived Endpoint for Key Endpoint Use

Posted on April 5, 2022January 31, 2025 by Hannah Faulkner

Preparing a Digitally-derived Endpoint for Key Endpoint Use

Posted in Developing Novel Endpoints, Innovative Trials, Leveraging All Data, Novel Endpoints, Regulatory Submissions + Approvals, Resources, Study Design, Study Operations

Digital Health Trials: Recommendations for Developing Novel Endpoints Generated by Digital Health Technology for Use in Clinical Trials

Posted on April 5, 2022October 9, 2024 by Hannah Faulkner

Digital Health Trials: Recommendations for Developing Novel Endpoints Generated by Digital Health Technology for Use in Clinical Trials

Posted in Developing Novel Endpoints, Leveraging All Data, Novel Endpoints, Recommendations

Flowchart: Steps For Novel Endpoint Development

Posted on June 7, 2021January 31, 2025 by Hannah Faulkner

Flowchart: Steps For Novel Endpoint Development

 

Posted in Developing Novel Endpoints, Innovative Trials, Leveraging All Data, Novel Endpoints, Regulatory Submissions + Approvals, Resources, Study Design, Study Operations
 

DISCLAIMER: CTTI encourages the use of all materials listed on this site in the pursuit of improving the clinical trials enterprise. Our recommendations, tools, meeting summaries, and more are available to the public for free. We do ask that you acknowledge the source whenever using or referencing CTTI materials. Read our Citation Policy. 

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