A Survey of Industry Best Practice Metrics in Clinical Data Management and Biostatistics

Abstract

Over the past decade, internal and external pressures on the biopharmaceutical industry have posed the challenge of decreasing the time and cost associated with product development, in particular, the clinical trials process. While cost and time must decrease, quality must be maintained or improved. In an extremely competitive market, companies are constantly striving to improve the process of getting drugs to market quicker and more efficiently.

Fourteen pharmaceutical companies participated in a telephone survey of best practices and metrics in clinical data management and statistics. Eleven companies were global and three were based in one or two countries. Interviewees were leaders of data management; however, leaders of biostatistics, clinical operations, systems, standards, metrics, and information technology also participated.

The information gathered during this survey provides an overview of what the biopharmaceutical industry is doing with respect to metrics in data management and biostatistics. The interviewed companies provided examples of production, cost, quality, and performance metrics that are collected for their projects. The key metrics are the measures that companies routinely track on every project as indicators of success. The survey also provided valuable information on industry best practices in data management methods and standards.