August 7, 2012: Pain Database Standards Now Available on CDISC Website
The ACTTION STandardized ANalgesic DAtabase for Research, Discovery, and Submissions (STANDARDS) Working Group, in collaboration with the Clinical Data Interchange Standards Consortium (CDISC), recently completed developing a comprehensive CDISC-compliant analgesic clinical trial database structure for analgesic clinical trials. This database includes variables determined by extensive stakeholder input and from Case Report Forms provided by FDA and industry collaborators. A manuscript describing the development of the pain database standards has been submitted for publication, and the pain database standards and a user’s guide are available on the CDISC website (www.cdisc.org/therapeutic) and by a link from the ACTTION website.
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ACTTION Guide to Clinical Trials of Pain Treatments
The ACTTION Guide to Clinical Trials of Pain Treatments consists of two supplements published in the journal Pain Reports that include a series of articles describing research designs and methods, study conduct, outcome measures, data analyses and interpretation, and reporting recommendations for clinical trials of acute and chronic pain treatments.
Part I includes 9 articles that can be found here, and Part II includes 6 articles that can be found here.