Significance of observational data on type 2 diabetes management in North Africa.

The randomized controlled trial (RCT) methodology is often considered to reveal the most accurate data on a product’s safety and effectiveness. However, the value of an RCT post-approval is limited as clinical trial cohorts rarely represent the general patient population in real-life settings. Observational studies on the other hand yield better evaluations for safety and effectiveness in routine clinical care. It provides a snapshot of the patients’ daily life and highlights the barriers and constraints routinely faced by patients and physicians alike. Observational studies have the key advantage of garnering data from communitybased practitioners who have a better understanding of the population needs as opposed to the exposure that clinical trial specialists generally have. The results from RCTs are controlled by restrictive inclusion/exclusion criteria whereas treatment in clinics cannot be governed on selected groups of patients. Furthermore, the evidence on harms for medical interventions is primarily obtained from observational research. A study by Papanikolaou et al. comparing the evidence of harms from randomized versus non-randomized studies demonstrated that results from the latter were more conservative than randomized studies [1]. This suggests that data from both types of study designs should be weighed judiciously prior to defining a product’s safety profile. In situations when two approved drugs have to be compared under routine clinical care, an observational study would be more appropriate than a controlled trial. Observational principles also ensure the best consequences in studies on epidemiology, pharmacoepidemiology, statistics, health economics and outcomes research and health surveys.