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Milestone 3.D

Enable access to data and associated biosamples and biomarkers from completed, ongoing, and future federally and privately funded clinical trials to clarify the biomarkers’ predictive and theragnostic value, to identify surrogate endpoints, and to advance the understanding of heterogeneity of disease and treatment response.

Success Criteria

  • Provide supplemental funding to enhance completed and ongoing clinical trials with molecular profiling of minimally invasive specimens (serum, peripheral monocytes, microbiome etc.) and use these molecular signatures as indicators of responsiveness and for disease sub-classification.

  • Develop standard consenting language, simplified data, and material transfer agreements, and provide support for big data infrastructure to ensure the rapid, widespread and appropriate, use/reuse of data and biosamples.

  • Align funding incentives across federal and non-federal/private trial sponsors to ensure rapid and broad access to data and associated biosamples and biomarkers from legacy, ongoing and future clinical trials.

Research Implementation Area
Data Sharing and Reproducibility
In Progress

Accomplishments/Implementation Activities

Funding Initiatives

Research Programs and Resources

Research Highlights

Relevant Recommendations