Panvigilance — a strategy to integrate biomarkers in clinical trials to enhance drug safety

New Rochelle, NY, April 1, 2019–Modern medicines have positively contributed to public health and changed the ways human diseases are prevented and treated. Yet, most drugs are not without side effects. Adverse drug reactions (ADRs) rank among the leading causes of morbidity and mortality worldwide. The current paradigm of drug development can detect only the most common ADRs in clinical trials.

A new strategy to enhance pharmacovigilance signal detection for ADRs, drug safety and efficacy was described in a technology horizon scanning article, “Toward Panvigilance for Medicinal Product Regulation: Clinical Trial Design Using Extremely Discordant Biomarkers”, published in the March issue of OMICS: A Journal of Integrative Biology, the peer-reviewed interdisciplinary journal by Mary Ann Liebert, Inc., publishers.

The article introduces the concept “panvigilance” as a systems approach to pharmacovigilance. Panvigilance is based on forecasting of signals on unknown drug effects, be they adverse, toxic, or therapeutic, by prioritizing pharmacokinetic and pharmacodynamic analyses in population edges as defined by biomarkers. Subsequently, it becomes easier to extrapolate drug safety and effectiveness performance to the general population.

An expert review article on panvigilance was also published in the same issue of OMICS, “Panvigilance: Integrating Biomarkers in Clinical Trials for Systems Pharmacovigilance”, coauthored by Semra ?arda? and Asl?gül Kendirci at ?stinye University in ?stanbul, Turkey. The corresponding author for the expert review, Professor Semra ?arda?, PhD has noted “Panvigilance offers a new opportunity for integration of biomarkers in clinical trials beyond traditional contexts such as personalized medicine. Moreover, panvigilance and pharmacovigilance are complementary. Panvigilance approach can be applied not only to pharmaceuticals but also vaccines, nutrition research, cosmetics and medical devices as well.”

Vural Özdemir, MD, PhD, DABCP, Editor-in-Chief of OMICS, has commented, “As with aircrafts or automobiles tested in wind tunnel experiments, new medicines, too, warrant stress testing to identify, early on, their safety performance under conditions that mimic the population extremes (edges) in regards to drug pharmacokinetics and molecular targets. Panvigilance clinical trial design, as described in the March issue of OMICS, offers innovation to reduce drug development risks and design medicines with greater safety performance and predictability in the clinic.”

These articles are available free on the OMICS website until May 1, 2019.

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About the Journal

OMICS: A Journal of Integrative Biology is an authoritative and highly innovative peer-reviewed interdisciplinary journal published monthly online, addressing the latest advances at the intersection of postgenomics medicine, biotechnology and global society, including the integration of multi-omics knowledge, data analyses and modeling, and applications of high-throughput approaches to study complex biological and societal problems. Public policy, governance and societal aspects of the large-scale biology and 21st century data-enabled sciences are also peer-reviewed. Complete tables of content and a sample issue may be viewed on the OMICS: A Journal of Integrative Biology website.

About the Publisher

Mary Ann Liebert, Inc., publishers is a privately held, fully integrated media company known for establishing authoritative peer-reviewed journals in many areas of science and biomedical research, including Journal of Computational Biology, ASSAY and Drug Development Technologies, and Zebrafish. Its biotechnology trade magazine, GEN (Genetic Engineering & Biotechnology News), was the first in its field and is today the industry’s most widely read publication worldwide. A complete list of the firm’s 80 journals, books, and newsmagazines is available on the Mary Ann Liebert, Inc., publishers website.