Signal Detection and Analysis

To meet the regulatory requirements of post-approval drug safety, PPD mobilizes the experience of its pharmacovigilance and pharmacoepidemiology teams to conduct signal detection analysis. We utilize standard desktop and pharmacovigilance technologies, including signal detection and data mining software, and databases supportive of drug safety research.

Once a product is marketed, an increased number of patients may use it, including those with multiple health conditions and those using a variety of therapies. PPD’s experienced safety reviewers, utilizing our adverse event reporting systems, analyze these larger, complex patient populations to address a variety of drug safety questions.

Periodic Safety Update Report Development

Our periodic safety update report (PSUR) process integrates safety information from multiple functional areas and sources of data, both internal and external to the client. The essential elements of signal detection in the PSUR are:

• Presentation of cases as line listings
• Analysis of individual case histories
• Evaluation of aggregate summary tabulations
• Development of patient exposure estimates for adverse event rate calculations
• Outline of risk management programs and risk-benefit analyses

PPD specializes in evaluating literature on observational epidemiology studies, an often overlooked body of medical literature. Regulatory agencies are now using results from observational studies for the basis of taking regulatory action.

Data mining

Using both SAS software and automated signal detection technologies that incorporate statistical algorithms, PPD detects and assesses drug safety signals from post-approval adverse drug reaction databases (e.g., FDA AERs). These automated software programs all include the ability to evaluate safety signals analytically and visually in an interactive or batch mode.

Additional Analyses

PPD also has expertise in:

• Performing ad hoc analyses of clinical trial data in support of successful label changes
• Conducting meta-analyses of safety data from observational epidemiologic studies
• Providing trend analysis on all serious reports; any events suggesting potential signals that may require labeling change or FDA/health care professional notification are formally tracked