Maximally Leveraging All Available Data

Maximally Leveraging All Available Data

Electronic health record data and real-world data, collected through the routine delivery of health care, are potentially powerful tools for enhancing the quality and efficiency of clinical trials. We can use existing data to plan eligibility criteria, assess trial feasibility and generalizability, and target recruitment efforts to shorten timelines and enhance patient access to research efforts. Appropriately sharing data and methods with all researchers and sponsors can spark collaboration and innovation in clinical trials. In CTTI’s 2030 vision for clinical trials:

  • Clinical trials are enhanced by the integration of new types of data, such as consumer and digital data.
  • Data are accessible, with appropriate governance and controls, to all researchers and sponsors.
  • Use of EHR data and other relevant available data from trial participants is straightforward.
  • Linkage with health plan claims data for trial participants is simple when beneficial for trial conduct.
  • Data platforms support multiple clinical trials, rather than being built for individual trials.
  • Choices of data sources and methodologies correspond to the level of evidence needed to answer the research question and considers how the study results will be used.
  • Data standards and definitions are in place to support integration of data from various sources, and the systems are interoperable.
  • Common standards exist to address privacy and security in an easily implementable and transparent manner.

Resources

Site Planning | Press Releases

CTTI Launches New Online Digital Health Trials Hub

Today the Clinical Trials Transformation Initiative (CTTI) announced a new online Digital Health Trials Hub featuring enhanced recommendations and additional resources.


Regulatory Submissions + Approvals | Webinars

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

Site Planning | Webinars

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,...

Regulatory Submissions + Approvals | Resources

Regulatory Engagement Opportunities when Developing Digitally Derived Endpoints

Regulatory Engagement Opportunities when Developing Digitally Derived Endpoints

Regulatory Submissions + Approvals | Resources

Question Bank for Identifying Meaningful Outcome Measures

Question Bank for Identifying Meaningful Outcome Measures

Regulatory Submissions + Approvals | Resources

Preparing a Digitally-derived Endpoint for Key Endpoint Use

Preparing a Digitally-derived Endpoint for Key Endpoint Use

Recommendations

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

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

Regulatory Submissions + Approvals | Resources

Flowchart: Steps For Novel Endpoint Development

Flowchart: Steps For Novel Endpoint Development