New Tool for Safety Research Study Design in Pharmacovigilance and Pharmacoepidemiology

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The first edition of Post-Authorization Safety Studies of Medicinal Products: The PASS Book has been published and is now available online.

The book serves as an essential reference for pharmacovigilance scientists and pharmacoepidemiologists searching for the appropriate study design to answer safety research questions in studies required by regulators. Two RTI Health Solutions (RTI-HS) researchers are contributors. 

Prospective Study Designs for PASS
The goal of Chapter 6.5, Prospective Study Designs for PASS, is first to clarify the meaning of the word prospective in the classification of studies and then to describe the most common prospective designs. The description for this chapter states, “A prospective study is defined as a study whose experience is concurrent with the execution of the study. Prospective studies involve forming a cohort of participants at zero time and observing them over a future period. This contrasts with a retrospective study, which looks backwards and studies the past in relation to zero time.”

Alejandro Arana, MD, MPH, Senior Director of Epidemiology at RTI Health Solutions, contributes to the chapter, and reminds us that prospective PASS can be interventional (clinical trials, pragmatic trials, large simple trials, randomized database studies, and registry-based randomized trials) or observational (mainly prospective cohort studies, including registries).

PASS for Medical Devices and Combination Products
Mary Beth Ritchey, PhD, Director Epidemiology, Medical Devices at RTI-HS, contributed to Chapter 10.2, PASS for Medical Devices and Combination Products. The chapter focuses on factors that differentiate PASS for medical devices and combination products from the more common setting of pharmaceuticals. It provides an overview of regulations in the context of the evolving medical device regulatory landscape, discusses the appropriateness and limitations of various data sources, and covers challenges in design and analysis methods related to the study of devices and combination products. 

PASS for medical devices and combination products. In: Ayad Ali, Abraham Hartzema, editors. Post-authorization safety studies of medicinal products. 1st ed. Cambridge: MA. Academic Press; 2018. Hardcover ISBN: 9780128092170

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