RALEIGH, NC – As we honor May as Mental Health Awareness Month in the midst of a global pandemic, it is now more important than ever to use this time to share the importance of mental health treatment, support and service, and do so by providing our own experiences to help one another. Today we celebrate our Senior Director of Biometrics & Submissions, Jen Nash, who has dedicated her time, effort, and life’s work into advocating for mental health awareness and research.
Most recently, Jen has contributed to research efforts in the areas of Major Depressive Disorder (MDD) and Post-Traumatic Stress Disorder (PTSD). Recent studies have shown that mental health disorders have a larger economic cost burden than any other somatic disease. As a complex disease, significant research is still needed to understand and treat these disorders. Jen Nash recently earned her master’s degree in bioinformatics, and completed her master’s thesis work centered on the mapping of Electronic Health Record (EHR) data to the MDD and PTSD non-standard Study Data Tabulation Model (SDTM) variables outlined in their respective Therapeutic Area User Guides (TAUGs). Several studies have looked at the availability of Electronic Health Record (EHR) data through the Fast Healthcare Interoperability Resources (FHIR) standard; however, only standard variable data from the SDTM and Analysis Data Model (ADaM) were considered in these studies. The SDTM standards focus on safety and other data in common across all therapeutic areas. In making decisions to adopt FHIR for a single study or more broadly, the percent of study data routinely available through FHIR resources is a key factor. Because efficacy data is less commonly represented in SDTM domains, therapeutic area data element work is necessary. To assess the availability of efficacy data for Phase III mental health studies, Jen and her team mapped FHIR Resources at a maturity level 3 and above to the FDA Therapeutic Area (TA) non-standard data elements listed in the Clinical Data Interchange Standards Consortium (CDISC) TAUGs for MDD and PTSD. An average of 63% of the TAUGs’ data elements for the assessed mental health therapeutic areas mapped to maturity level three or above. Additionally, 90% of the data elements for the respective therapeutic areas mapped when considering all resources regardless of maturity level. Preliminary mappings were vetted and presented to the FDA showing an example of end to end mappings. This work has also been shared with larger initiatives attempting to map SDTM variables across all therapeutic areas from FHIR R4 resources.
We would like to thank Jen for her continued contribution to the Mental Health Research field. We honor all the individuals who dedicate their time to creating a world where good mental health is the foundation of a good life. For more information on how to get involved in Mental Health Awareness Month, visit https://www.nami.org/Get-Involved/Awareness-Events/Mental-Health-Month.