ACTTION
The mission of the Analgesic, Anesthetic, and Addiction Clinical Trial Translations, Innovations, Opportunities, and Networks (ACTTION) public-private partnership is to identify, prioritize, coordinate, and sponsor innovative activities that will expedite the identification and development of efficacious and safe analgesic, anesthetic, and addiction therapeutic interventions for the benefit of the public health.
ACTTION, a public-private partnership between the University of Rochester and FDA, will transform, harmonize, merge, and pool raw patient-level data in FDA’s Document Archiving, Reporting & Regulatory Tracking System (DARRTS) from phase 2 and 3 acute and chronic pain trials.
Using both patient-level and pooled raw data, the investigators are analyzing patient and study design factors associated with assay sensitivity and placebo group response. Statistical issues and the responsiveness of existing primary and secondary outcomes will also be evaluated. Moreover, ACTTION will assess methods for determining the clinical importance of analgesic trial outcomes, including responder analyses.
Using both patient-level and pooled raw data, the investigators are analyzing patient and study design factors associated with assay sensitivity and placebo group response. Statistical issues and the responsiveness of existing primary and secondary outcomes will also be evaluated. Moreover, ACTTION will assess methods for determining the clinical importance of analgesic trial outcomes, including responder analyses.
IMMPACT
PCORI
PCORI helps people make informed healthcare decisions, and improves healthcare delivery and outcomes, by producing and promoting high-integrity, evidence-based information that comes from research guided by patients, caregivers, and the broader healthcare community.
Abt Associates
Advancing Regulatory Science - analysis of FDA clinical trial data to improve assay sensitivity
NSF Releases JASON Report on Research Security pdf
