The work proposed here will result in synthesized data elements for Bipolar and Generalized Anxiety Disorders, for use in human drug development and evaluation. Bipolar Disorder and Generalized Anxiety Disorder are two FDA priority areas for data standardization.
The first aim of this work analyzes data collection forms (Case Report Forms (CRFs)) from new drugs approved since 2000 with an approved indication in Bipolar Disorder or Generalized Anxiety Disorder, to generate a master data element set that will support consistency in data collection by trial sponsors. The data elements will be vetted with clinical experts and harmonized with existing standards.
The second aim of this work will be brought forward as a project in the HL7 Clinical Interoperability Council with the intent of balloting as an HL7 standard at the informative level. Ultimately, the data elements will be publically available through a public metadata registry. The team will annotate the data elements with mapping to existing terminology standards and to the CDISC SDTM, further increasing usefulness to the regulated industry of this resource. The third and final aim of this work explores rich terminologies relevant to regulatory decision-making in mental health, e.g., drug terminologies, structured document standards, e.g., structured product label, curated questionnaires, and an exploratory ontological representation of the Bipolar Disorder section of the Diagnostic and Statistical Manual of Mental Disorders, to identify links with standard data elements. Suck links will increase the types of questions that can be asked of data from regulatory submissions. !
FDAs use of data for regulatory decision-making is hampered by variability in the way data are defined and submitted. Further, current data standards for regulatory submission do not cover therapeutic area specific data, including many measures used to assess the efficacy of new therapeutics. We directly address these challenges by 1) generating a set of standardized and publically available data elements for Bipolar and Generalized Anxiety Disorders two therapeutic areas currently prioritized by the FDA for data standardization, and 2) demonstrating and evaluating the amount of additional information contributed to the regulatory decision- making process by linking the Bipolar Disorder data elements developed under this grant to existing sources of knowledge such as drug terminologies and the Diagnostic and Statistical Manual of Mental Disorders (DSM).