Monitoring Clinical Trial Data Using an Unblinded Industry Statistician

Abstract

The three-statistician model of monitoring data from an ongoing trial generated strong reactions from the statistical community. At controversy is the recommendation that an independent statistician serves as unblinded liaison to the data monitoring committee (DMC). We share our experience with using an industry statistician as the unblinded liaison in a study on the early treatment of patent ductus arteriosus in premature infants. The DMC membership included an academic consulting statistician. A DMC charter was drawn up laying down the expectations for committee members. The study statisticians were not involved in dealings with the DMC. Only the liaison statistician responsible for generating reports and analyses was aware of the grouped results A versus B. A report generation process was established ensuring a firewall for maintaining confidentiality of results. In certain situations, employing an industry statistician as the unblinded liaison to the DMC is a viable option for monitoring data.

Learning Objectives

Upon completion of this article, participants should be able to:

• •

Describe an example of using a sponsor statistician as unblinded liaison to the data monitoring committee (DMC)

•

Present the elements of a DMC charter and a process for preparing DMC reports

•

Discuss considerations for determining when using an unblinded industry liaison to the DMC is a viable option for monitoring data

•

Discuss the advantages and disadvantages of using an industry statistician as an unblinded liaison to the DMC

Target Audience

This article is designed for anyone involved with the clinical trial process including: statisticians, clinical research associates/monitors, clinical data managers, project managers, site coordinators, and data coordinating center personnel, and for potential data monitoring committee memebers including physicians and scientists.