A Survey of Industry Best Practice Metrics in Clinical Data Management and Biostatistics
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0092-8615/2001 Copyright 0 2001 Drug Information Association Inc.
A SURVEY OF INDUSTRY BEST PRACTICE METRICS IN CLINICAL DATA MANAGEMENT AND BIOSTATISTICS RONALDD. FITZMARTIN, PHD, MBA Group Executive Director, Worldwide Clinical Data Operations and Systems, Purdue Pharma L.P., Stamford, Connecticut
KIMNITAHARA, MBA, MIT President, META Technologies, Inc., Warren, New Jersey
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 eflciently. 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 pegormance 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. Key Words:Data management; Biostatistics; Best practices; Metrics; Process improvement
INTRODUCTION 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 expedite the drug development process by implementing more efficient and effective processes and systems.
METHODOLOGY Industry Survey Procedures
A best practice metrics questionnaire was developed to collect specific information from both-biopharmaceutical companies and contract research organizations (CROs) on their Reprint address: R~~ ~ i ~ one hStamford , F~~~ Stamford, CT,06901. E-mail: [email protected]. best production, performance, cost, and qualDownloaded from dij.sagepub.com at671 UNIV OF BIRMINGHAM on April 21, 2015
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Ronald D. Fitzmartin and Kim Nitahara
ity metrics in data management and biostatistics. This questionnaire was designed to collect the information in a telephone interview of approximately 30 to 45 minutes. It was determined that, in order to recruit interviewees to participate in the s
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