Phase IV Clinical Trials

Invigor Consulting chief executive officer Dr. Deirdre Gillespie advises clients in the pharmaceutical and biotechnology industries on corporate financing, investor relations, general management, and other common issues. An investigator in multiple clinical studies, Dr. Deirdre Gillespie has participated in the entire developmental life cycle of new medications, including bringing them to Phase IV clinical trials in the United States and Europe.

The final part in the clinical trials process, Phase IV occurs after the U.S. Food and Drug Administration or the European Medicines Agency approves the drug or device for consumers. Also known as “post-marketing surveillance trials,” Phase IV trials allow pharmaceutical companies to gain greater knowledge about their products on the open market. They can see how a product compares to similar products, identify its long-term effectiveness, monitor how it interacts with other drugs, and notice potential safety risks.

Moreover, Phase IV trials provide them with information from a greater number of consumers, who represent more varied age ranges and ethnicities than available through the earlier clinical trials. This allows the pharmaceutical companies to further differentiate data based on groups and subgroups and to better understand its applicability to the public. Products have been removed from sale or been given restrictions on use due to Phase IV findings.