The Growing Role of the Biostatistician in Safety Assessment of Clinical Trials for Regulatory Approval

• Activity Number: 29
• Type: Contributed
• Date/Time: Sunday, August 8, 2004 : 2:00 PM to 3:50 PM
• Sponsor: Biopharmaceutical Section
• Author(s): Michael Nessly*+
• Companies: Merck & Co., Inc.
• Keywords: clinical trials ; safety analyses ; graphical analysis ; reference ranges ; laboratory toxicity ; antiretroviral therapy

Abstract

There is a strong perception that issues surrounding safety of approved drugs, biologicals and devices are increasing in scope and scale. Safety data will be under increasingly greater scrutiny in the future. Despite the large quantity of safety data acquired during clinical drug testing, safety data are rarely collected nor analyzed to their fullest potential For simple trial designs, the standard safety analysis approach of tables of adverse experience counts and listings is generally adequate. However, due to complexities of long-term longitudinal clinical trials, biostatisticians are more frequently being engaged in the analysis and review of safety data in regulatory submissions. Simplistic and sometimes automated approaches of tabulation of safety data as crude frequencies are not the most relevant means to characterize the safety profile of a new treatment. There are cases where exploration of all of the data are revealing with respect to potential underlying mechanisms. The use of more involved methodology in context of recent safety initiatives involving antiretroviral therapy will be presented. Requirements for submission safety analysis datasets will be discussed.