ABSTRACT
Safety surveillance, also referred to as pharmacovigilance, is dened as “the science and activities relating to the detection, assessment, understanding and prevention of adverse effects or any drug-related problem” [1]. Medicinal products (drugs) are required to follow a rigorous and highly regulated development process before they are allowed to be brought to market. Controlled clinical trials conducted prior to the granting of market authorization involve systematic and organized collection and analysis of adverse event data, as well as other data relevant to drug safety (e.g., electrocardiograms, laboratory measurements for liver and renal function). Although the controlled clinical trials are considered a hallmark of demonstrating the efcacy of a drug, safety data available from those trials have
CONTENTS
6.1 What Is Safety Surveillance? ...................................................................... 93 6.2 Recent Trends in Pharmacovigilance........................................................ 94 6.3 What Is a Safety Signal? .............................................................................. 95 6.4 Natural History of Safety Signals.............................................................. 96 6.5 Process for Safety Signal Detection, Assessment, and Management ...98 6.6 Data Sources and Statistical Data Mining Methods That Are
or May Be Used for Safety Signal Detection .......................................... 101 6.7 Relationship of Signal Detection to Risk Communication, Risk
Management, and Benet-Risk Evaluation Processes ......................... 103 6.8 Conclusions ................................................................................................. 104 References ............................................................................................................. 104
generally well-recognized limitations, such as the limited number of study subjects included in the trials (compared with the size of patient populations that may be exposed to the drug once on the market), the limited duration of exposure to the drug per study subject (particularly relevant in the case of a therapy intended for long-term use), and limited or no data in potentially higher-risk patient subpopulations that are often excluded from controlled clinical trials (e.g., patients with organ impairment, pediatric and geriatric patients, and women of childbearing age who may be treated during pregnancy and lactation). These limitations make it necessary that the marketing authorization holder of a drug and regulatory authorities continue to collect, analyze, and interpret data relevant to patient safety that become available after the drug is approved for commercial use.
