Beyond Number Crunching and Data Monitoring: Challenging Roles for CRO Statisticians

• Activity Number: 535
• Type: Roundtables
• Date/Time: Wednesday, August 1, 2012 : 12:30 PM to 1:50 PM
• Sponsor: Section on Statistical Consulting
• Author(s): Jia Hu*+ and Mark Mortier and Elizabeth Ludington
• Companies: Synteract Inc. and Synteract Inc. and Synteract Inc.
• Keywords: CRO ; statistician ; service ; consulting ; collaborative ; challenge

Abstract

As service providers, contract research organizations (CROs) for clinical trials and studies are expected to meet the demands and needs of sponsors. Typically, CRO statisticians are seen as passively, and often obediently, following orders from sponsors. Such statisticians rarely have the chance to provide feedback regarding the appropriateness of study rationale, design and procedures. However, CRO Statisticians can contribute more by conducting an informed, thorough, and comprehensive critical analysis. As the competition for conducting clinical trials increases by emerging pharmaceutical companies with little or no trial experience, it is pivotal for CRO statisticians to maintain an effective collaborative and consultative working relationship with their counterparts and the Principal Investigators from the sponsoring group. The proposed roundtable discussion will focus on examining issues related to challenges for CRO statisticians including facing the increasing demands and needs from the sponsors. We would like to discuss how CRO statisticians can be more proactive and collaborative, and how to strategically adjust to new roles beyond the passive data analysis and monitoring.