While post-approval research is evolving rapidly, and these studies are becoming far more complex, our knowledge in implementing and conducting such studies has not evolved with the same pace. There are fundamental differences in conducting research in pre-market randomized controlled trials (RCT) versus post-approval research. These differences are not only in the study intent and objectives but the operations and conduct. Applying appropriate regulatory regulations for post-approval research is an art not a science. Often we see the same regulatory rigor applied to post-approval research as RCTs which leads to inappropriate design and execution. Consequently, these studies become cost prohibitive.
Post-approval research studies are often massive and global with tens of thousands of patients and thousands of physicians. Managing such studies requires uniquely different operational infrastructure as well as processes. SOPs must be specially designed to support such studies and the operational mindset must be geared towards how to effectively manage research naïve physicians and implement patient centric approaches. Utilizing smart technology in not only desirable but necessary to contain study costs. By deploying such technology you will minimize resource burn and decrease costs.
Lastly, not all post-approval research studies are the same. Each study must be reviewed to ensure the correct strategies are applied for the various types of post-approval research.