Nicole Harmon PhD, Chief of Staff, CDISC

CDISC is proud to have been featured as a partner with the FDA in their 2015-2016 Regulatory Science Progress Report highlighting their efforts to collaborate with Scientific Consortia to ensure the safety quality and efficacy of medical products. CDISC related highlights in the report included FDA’s efforts to establish common standards for data reporting providing new opportunities to transform the massive amounts of data from clinical studies on specific diseases into information that can be easily grouped for reporting and analysis.  In October 2015, FDA published the third version of the Therapeutic Area (TA) Standards Initiative Project Plan, which guides all major aspects of their multi-year initiative to develop and implement TA standards to support the regulatory review process.  The list of the prioritized TAs and their development status was revised to reflect progress made and changes in CDER priorities.  Of the 54 TAs on this list, 42 are already being used at FDA to capture business needs, or are under development with external parties.  


During this 2015-2016 time period, our work through the CFAST Consortia allowed the development of 10 new therapeutic area data standard user guides for the following areas: 1) cardiovascular studies 2) influenza 3) QT studies(drug-induced cardiotoxicity) 4) schizophrenia 5) hepatitis C 6) dyslipidemia 7) chronic obstructive pulmonary disease 8) general viral resistance 9) traumatic brain injury 10) tuberculosis


Also featured in the report are our continued collaborative efforts with the Critical Path Institute, Coalition Against Major Diseases (CAMD), Critical Path to TB Drug Regimens (CPTR) Consortium, Polycystic Kidney Disease Outcomes (PKDOC) Consortium;  and Multiple Sclerosis Outcome Assessments Consortium.


Finally the report featured a demonstration in the nonclinical area, publishing an update of the validation rules for Standard for Exchange of Nonclinical Data (SEND) formatted files.


CDISC is grateful to all our Scientific Consortia featured in this document and the many others we work with throughout the years to develop new data standards fostering Smarter Research to Unlock Cures.