FIRST QUARTER 2016 CDISC eNewsletter IN THIS ISSUE:


PAGE 1 LETTERS FROM CDISC LEADERSHIP


Breaking Down Silos COO Perspectives


PAGE 4 FEATURED ARTICLES


Breaking Out of Silos - Moving Toward End-to-End Standards Development


Interoperability - Even with the Regulators


CDISC Hosts First Fundraiser to Support PTS & Mental Health Research


My Fellowship at CDISC


Second Class of CDISC Fellows Begins


PAGE 10 CDISC IN THE NEWS


PAGE 13 STANDARDS UPDATES PAGE 14


CDISC AROUND THE GLOBE


PAGE 17 CDISC EDUCATION


Breaking Down Research Silos with New Course Teaching Standards Beginning to End


PAGE 20 MEMBERSHIP UPDATE


PAGE 22 UPCOMING EVENTS


CDISC CDIS CDI C WEBSIT LINK WEBSITE LINK 1


First Quarter Theme: “Standards Break Research Data Silos”


Breaking Down Silos Dr. Rebecca Kush, CDISC President & CEO


In an effort to explain to clinicians and patient groups what we do within CDISC and why


standards are


important, CDISC launched a new campaign and a


sister website,


www.unlockcur e s .or g. Th e Communications group in the Texas Medical Association building where we have our office responded to these new messages


with “We finally


understand what you do!” It is not easy to explain data standards to those who might already assume that data flows readily between systems and can be understood at both ends, resulting in useful databases. Or, more likely, to explain standards to those who have not really thought much about this at all.


One of our Unlock Cures themes has been “When Clinical Research is Done in Silos, We Can’t Harvest Cures.” This resonates with those of us who know that this, unfortunately, is how most research is currently done. Examples of how therapeutic area standards have been valuable in breaking down silos and “getting data to talk” are: a) C-Path’s Coalition Against Major Diseases (CAMD) Alzheimer’s


database, for which CDISC standards enabled


aggregation of data across 9 companies into a database that now has data from over 6,000 patients in a common format; b) the biomarker that has now been approved to diagnose and treat patients with polycystic kidney disease (PKD) much earlier because data were shared and a standard developed, and c) the work we have done with One Mind.


One Mind is about ‘open science’ and collaboration and recognizes the value of CDISC standards for mental health. Through a partnership with One Mind, CDISC has been able to transform standards developed through NIH into global,


consensus-based CDISC standards that can now support FDA


submissions and biomarker qualification for Traumatic Brain Injury. Our recent event to raise funding for a standard for Post-traumatic Stress and Mental Health will build upon this and other standards we are developing through


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