Pro Bono (SWB) Statistical Analysis of a Randomized Double Blind Clinical Trial, or 'Is Our Project Done Yet?'

• Activity Number: 291
• Type: Contributed
• Date/Time: Tuesday, August 5, 2014 : 8:30 AM to 10:20 AM
• Sponsor: Statistics Without Borders
• Author(s): Chris Barker*+
• Companies: InVentiv Health Clinical
• Keywords: pro bono ; statistics without borders

Abstract

Statistics Without Borders (SWB) was contacted in January 2102 by a nutrition scientist in Peru with a request to prepare an analysis of a double blind randomized clinical trial of a food additive in young children to prevent life -threatening diarrhea.

Key project deliverables were required within about 60 days from receipt of the request. The deliverable timing was based on the visit of a UN team reviewing the project. The project proceeded intermittently. Completion of the project required creating three separate SWB teams. The project was considered officially complete more than a year after the original request, around October 2013.

This presentation will discuss the primary endpoint analysis findings. Briefly the clinical trial was determined to have a null, (No effect) finding for the primary endpoint.

The presentation will also highlight the major contributions of multiple SWB volunteers in two separate teams, over an extended time period, to provide critical deliverables, with an initial "very aggressive timeline".