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The Challenges of Signal Detection in Spontaneous Reporting

Posted on September 13th, 2017 by in Pharmacovigilance


Pharmacovigilance is essential to pharmaceutical businesses. It facilitates the correct use of a drug, safeguarding the drug as a meaningful treatment option when the benefits it offers outweigh known risks, or measures can be taken to mitigate those risks.

Improving patient safety is a core objective of pharmacovigilance, but so is effective patient care. More than just monitoring for evidence that a drug triggers an adverse reaction, pharmacovigilance is a systematic, detailed and iterative examination of the risks that a drug poses to a patient population versus the benefits that it affords. It is about drug stewardship, with workflows designed to gather data and evaluate new knowledge to define when and how a drug should be used.

Dr. Laszlo Urban is Global Head of Preclinical Secondary Pharmacology at the Novartis Institutes for Biomedical Research. For over a decade, he has explored and successfully implemented systems to inform the development of new drugs with insights from the clinic about adverse events. As he sees it, “pharmacovigilance is a sentinel. It serves to draw drug developers’ attention to any aspect of a drug or group of drugs that can impact not only the way a drug is perceived, used and managed but also the way a company goes about developing new therapies.”

Unfortunately, the view of the “sentinel” is not always clear. Working with spontaneous adverse event reporting systems — that is, information that is voluntarily submitted to authorities or MAHs — poses challenges. Overcoming these requires not only gathering relevant data from multiple sources but also leveraging these to guide the process by which the connection between an adverse event and a drug is verified.   

Read the white paper to learn more: Signal Detection in Spontaneous Reporting Databases — Sentinels in a Cluttered Landscape.

All opinions shared in this post are the author’s own.

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