Tempe, AZ, June 4, 2019 – SDC is proud to announce that two team members have been invited to present at PharmaSUG 2019 in Philadelphia, PA on June 16-19. Bharath Donthi, MS, Associate Director, SAS Programming, will present his paper titled “Best Practices for ISS/ISE Dataset Development” on Tuesday, June 18 at 9:30am. Lingjiao Qi, PhD, Senior SAS Programmer, will present “Automating SAS Program Table of Contents for Your FDA Submission Package” on Wednesday, June 19 at 1:30pm. Bharath and Lingjiao are co-authors on both papers accepted for presentations. For more information about PharmaSUG or to register for the conference, please visit https://www.pharmasug.org/us/index.html.
Best Practices for ISS/ISE Dataset Development
Bharath Donthi, MS, Associate Director, Statistical Programming at SDC
Tuesday, 1:30 PM – 1:50 PM, Location: Salon C
The integrated summary of safety (ISS) and integrated summary of efficacy (ISE) are vital components of a successful submission for regulatory approval in the pharmaceutical industry. ISS and ISE allow reviewers to easily compare individual outcomes, tracking subject’s results across the entire clinical development lifespan of the investigational product. Furthermore, ISS/ISE facilitate broad views of the investigational product’s overall efficacy and safety profiles. However, building integrated datasets is a challenging task as it requires the programmer to achieve consistent structures and formats while also ensuring that each dataset is CDISC-compliant. This paper provides best practices for ISS and ISE dataset development to guide integrated analysis dataset design and production in an efficient manner. First, we discuss best practices to ensure the consistency of integrated datasets by up-versioning all data with the same coding dictionaries (MedDRA, CTCAT, WHO, etc.) and by harmonizing all variable attributes (variable names, types, formats, labels, CODE and DECODES for categorical and ordinal variables, ranges for continuous variables, etc.). Next, we discuss CDISC requirements regarding the mapping of SDTM and ADaM. Then, we will talk about how to handle some complex cases in developing integrated datasets, such as when one subject participates in multiple clinical studies included the ISS/ISE. Finally, we will touch on key points of analysis involving consistent flag assignment across studies and proper application of integration methods for safety and efficacy analysis. This step-by-step guide enables the efficient and accurate creation of ISS and ISE datasets.
Automating SAS Program Table of Contents for Your FDA Submission Package
Lingjiao Qi, PhD, Senior Statistical Programmer at SDC
Wednesday, 9:30 AM – 9:50 AM, Location: Franklin 3
To submit a complete and compliant data package to the FDA for product approval, the submission must include the SAS programs that generated the analysis datasets, tables, and figures. Including these programs in the submission package helps the FDA data reviewers to understand the process by which the variables for the respective analyses were created, and to confirm the analysis algorithms. Organizing these SAS programs into a Table of Contents is highly recommended as it serves as an easy reference for the FDA reviewers, verifies that each expected file is included in the submission, and provides the FDA with easily-accessible details for each program. The Table of Contents is usually compiled manually by reviewing each individual program and typing the required information into a word processor. This time-consuming process is inefficient and error-prone. To increase accuracy and efficiency, we have developed an in-house macro tool to automatically generate a Table of Contents by reading each submitted SAS program and its associated files. This easy-to-use macro tool can be fully executed within SAS, and it dramatically reduces documentation preparation time. To produce a complete and detailed Table of Contents, the macro tool extracts from the submitted programs: metadata (program name, size, descriptions, etc.), input datasets, output file names, and macros. This paper will provide a detailed description of our time-saving macro tool to assist SAS users in automatically generating the Table of Contents for their FDA data submission packages.