Compendium of Ethical and Methodological Standards (CEMS)

Invention

The Compendium is an interactive web-based interface which contains over 7,000 consensus standards on the ethical and scientific quality of clinical trials.  The information is gathered from various regulatory agencies including the U.S. FDA, government cooperatives (including the International Council for Harmonization), professional organizations (including the World Medical Association), non-government organizations (WHO) and other national and international entities.  Standards are organized via a comprehensive, user-friendly taxonomy and tagged by therapeutic modality, subject population, trial setting, and source(s).  Downloadable results log the search, tags, and source material associated with each standard, allowing the user to compare related guidance across different professional, industrial, and jurisdictional contexts. 

 

Background

Currently in 2016, over 200,000 clinical trials are registered worldwide.  Overseeing and complying with the regulations and guidelines between multi-institutional and international trials becomes imperative in maintaining high clinical and ethical standards. To date, there is not an integrated system to search these clinical trial standards in a systematic or comparative fashion.  Clinical trials balance ethical and scientific requirements on an increasingly global scale, an interplay of values that needs to be better reflected in current accessible resources.

 

Advantages

·         Comprehensive, organized clinical trial standards information

·         Information from over 133 source documents

·         Easily accessible, searchable and comparable standards across international contexts

·         Standards categorized into trial stages, topics, and subtopics of ethical and scientific/ methodological importance

·         Standards analyzed individually and compared across sources to identify content corroborated by multiple authorities, and to categorize close variations of requirements together

·         Indexed systematically

·         Broad scope of users (investigators, sponsors, participants, oversight bodies, administrators, policymakers, and scholars)

·         Resource for publications

·         Electronic format allows frequent content updates and expansions

 

Publications

http://www.ncbi.nlm.nih.gov/pubmed/19717699/

http://www.ncbi.nlm.nih.gov/pmc/articles/PMC3571710/

http://www.ncbi.nlm.nih.gov/pmc/articles/PMC3567847/

http://www.ncbi.nlm.nih.gov/pmc/articles/PMC3567849/

http://www.ncbi.nlm.nih.gov/pmc/articles/PMC3478478/

http://www.ncbi.nlm.nih.gov/pmc/articles/PMC4165332/

 

Copyright Register

Copyrighted

 

Summary

https://tmhri.technologypublisher.com/files/sites/houston-methodist-invention---compendium-of-ethical-and-methodological-standards-(cems).pdf

 

 

Patent Information:
Licensing Contact
Belisa Diaz
bdiaz@houstonmethodist.org

Inventors: