What is an observational study and post-marketing surveillance?
Post-marketing surveillance involves the ongoing monitoring and evaluation of a drug after its regulatory approval. It complements earlier clinical trials by using large-scale population-based data that monitor the safety and effectiveness of a drug and its varied regimens used by the general patient population.
Previously, the efficacy of these treatments was studied through controlled clinical trials. However, participants of these trials tend to possess a higher average level of health literacy than individuals of the general population, and thus the outcomes of these studies (including treatment efficacy and adverse event frequency) may not represent results observed in the “real world”. Basing clinical practice guidelines on the results of these controlled trial data may therefore be flawed.
Post-marketing observational studies may determine small but significant treatment effects in routine clinical practice by tracking patients in the “real world” for longer and collecting a different broader set of end-points, including safety, patient preference, quality of life, and long-term effectiveness. This allows concerns about the safety of new medicines to be alleviated or brought to attention. It also improves clinical decision-making and individualization of patient treatment, with the ultimate goal of developing clinical practice guidelines.