Clinical Trials Monitoring

Phase IV Surveillance

Phase IV post-marketing research is becoming an increasingly integral part of the drug evaluation process because of problems that have surfaced with some drugs after their approval. But the challenges of monitoring drugs once they are approved are numerous.

One of the biggest challenges in the pharmaceutical world is understanding and impacting real-world persistence, adherence, and compliance to optimal drug therapies. Poor adherence and compliance leads to poor outcomes and reduced revenues, and this is a major factor in Phase IV research. Participants enrolled in a Phase IV study are prescribed the medication, but may not be taking the medication, or may be taking it irregularly or in incorrect dosing, and yet not report that information.

Phase IV safety surveillance is designed to detect any rare or long-term adverse effects over a much larger patient population and longer time period than was possible during the Phase II/III clinical trials. Yet the results of the Phase IV trials may be severely distorted by patient noncompliance, resulting in erroneous data.

A drug which incorporated SMART taggants for Phase II or III trials will typically incorporate the SMART capsule ingredients into the DMF on file with FDA. Therefore, the final approved drug will usually be manufactured with the SMART taggants still as an ingredient, allowing patient adherence to be cost-effectively monitored in Phase IV post-marketing surveillance.