Skip to main content

Thank you for visiting nature.com. You are using a browser version with limited support for CSS. To obtain the best experience, we recommend you use a more up to date browser (or turn off compatibility mode in Internet Explorer). In the meantime, to ensure continued support, we are displaying the site without styles and JavaScript.

  • Comment
  • Published:

The Predictive Safety Testing Consortium and the Coalition Against Major Diseases

The Predictive Safety Testing Consortium and the Coalition Against Major Diseases, both launched by the Critical Path Institute, provide valuable examples of the outcomes and lessons learned by different types of consortia working on new drug development tools.

This is a preview of subscription content, access via your institution

Access options

Buy this article

Prices may be subject to local taxes which are calculated during checkout

References

  1. Sistare, F. D. et al. Towards consensus practices to qualify safety biomarkers for use in early drug development. Nature Biotech. 28, 446–454 (2010).

    Article  CAS  Google Scholar 

  2. Dieterle, F. et al. Renal biomarker qualification submission: a dialog between the FDA-EMEA and Predictive Safety Testing Consortium. Nature Biotech. 28, 455–462 (2010).

    Article  CAS  Google Scholar 

  3. Hill, D. et al. CAMD/EMA biomarker qualification of hippocampal volume for enrichment of clinical trials in pre-dementia stages of Alzheimer's disease. Alzheimer's Demen. 10, 421–429 (2014).

    Article  Google Scholar 

  4. Ito, K. et al. Understanding placebo responses in Alzheimer's disease clinical trials from the literature meta-data and CAMD database. J. Alzheimers Dis. 37, 173–183 (2013).

    Article  Google Scholar 

Download references

Acknowledgements

D.S and J.-M.S. would like to thank L. Hudson for her contributions to this article. Funding for PSTC and CAMD included Science Foundation Arizona grant number SRG 0335–08 and US FDA grant number U01FD003865.

Author information

Authors and Affiliations

Authors

Corresponding authors

Correspondence to Diane Stephenson or John-Michael Sauer.

Ethics declarations

Competing interests

The authors declare no competing financial interests.

Related links

Related links

FURTHER INFORMATION

Coalition Against Major Diseases

Disease Specific Model Library

Predictive Safety Testing Consortium

Qualification opinion of a novel data driven model of disease progression and trial evaluation in mild and moderate Alzheimer's disease

Rights and permissions

Reprints and permissions

About this article

Check for updates. Verify currency and authenticity via CrossMark

Cite this article

Stephenson, D., Sauer, JM. The Predictive Safety Testing Consortium and the Coalition Against Major Diseases. Nat Rev Drug Discov 13, 793–794 (2014). https://doi.org/10.1038/nrd4440

Download citation

  • Published:

  • Issue Date:

  • DOI: https://doi.org/10.1038/nrd4440

This article is cited by

Search

Quick links

Nature Briefing: Translational Research

Sign up for the Nature Briefing: Translational Research newsletter — top stories in biotechnology, drug discovery and pharma.

Get what matters in translational research, free to your inbox weekly. Sign up for Nature Briefing: Translational Research