Dirk Spruck, Clinipace’s Manager of Statistical Programming, will share his expertise as part of a working group during the 5th annual Computational Science Symposium (CSS) held by PhUSE and the FDA March 13 – 15, 2016 in Silver Spring, Maryland.

Dirk and his collaborators, Hanming Tu of Accenture and Dante Di Tommaso of Roche, will present on behalf of the CS Standard Analyses Working Group. Their poster, titled “The Car is in the Shop, but Where are the Mechanics?”, reviews the future of standard scripts for analysis and reporting. The poster will also be presented at PharmaSUG 2016 in May in Denver, Colorado.

Dirk and his co-presenters will review the vision of the CS Standard Analyses Working Group, summarize its progress to date and outline proposals to resource further advances. After meeting its main goal of establishing a framework for standardizing analyses across the industry, the group has made progress along three main areas:

  1. The White Paper Project developed guidance on nine data analysis topics and published four papers.
  2. The Infrastructure Project established a GitHub code repository.
  3. The Content Project established implementation guidelines, established a qualification process and published scripts that display standard measures of central tendency.

Moving forward in 2016 and beyond, the group will work to promote adoption of these standard analyses; to coordinate review of, finalize and publish white papers; and to increase the scope, quality and usability of the standard scripts. However, the main challenges to completing the vision of a comprehensive framework for cross-industry standard analysis is the lack of resources. In order to fully realize its vision, the group will work to secure monetary funding, get dedicated resources from sponsors and collaborate with academic partners.

Leave us a comment or contact our team if you plan to be in attendance at CSS or if you would like to learn more about the goals and vision of the CS Standard Analyses Working Group. If you’d like to learn more about navigating regulatory biostatistical requirements throughout the clinical trial lifecycle, download our free webcast and eBook on the topic.

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