Imagine with me: After successfully enrolling in a clinical study, a subject is issued a wrist tracker and a digital skin patch, and is given login credentials for a proprietary app to download on her mobile phone and tablet. Over the course of the study, her wrist tracker and skin patch continuously collect and transmit […]
Posts Tagged ‘Adverse Event’
What Pharmacovigilance Means And Why It Matters
Pharmacovigilance, or the practice of monitoring the effects of medicines after they have been released for commercial use, was expanded in 2002 by the World Health Organization (WHO) to include signal detection as a way of improving patient care and improving the overall health and safety of the general public. Today, pharmacovigilance activities should also […]
The Role Of Signal Detection In Drug Safety
Due to the seriousness of adverse drug reactions, life sciences organizations perform something called “signal detection,” which is the process of evaluating potential safety signals. This entails looking at previously known associations between a drug and an adverse event, and looking at previously known drug-related issues that may be either improving or worsening. Not only […]
What Exactly Is An “Adverse Drug Reaction?”
While there are many ways to define “adverse drug reaction,” let’s use one that is fairly simply to digest: an unintended, harmful response that is suspected to be caused by a medicinal product being taken under normal circumstances. According to some sources, adverse drug reactions are the sixth-leading cause of death in the United States, […]
Why Monitoring Adverse Events And Drug Safety Signals Matters
It takes an average of 10 to 15 years and $2.6 billion for a drug to reach pharmacy shelves. While there are many steps in the process that contribute to this lengthy timeline and cost, no aspect of the process is more critical than proving the safety of a drug. Since a patient’s health is […]