What are the risks of giving a new drug?
Well before a product goes into clinical trials, drug safety experts should be involved in evaluating background events associated with indications of interest. This includes epidemiological investigations of the incidence and prevalence of diseases and their comorbidities. The class effects of drugs, and mechanism-based effects should be considered. In addition, risks uncovered during nonclinical development should be taken into account. For example, a finding of liver function test abnormalities in animal studies or toxicology studies finding liver-related issues can lead to an evaluation of the background of liver-related morbidity in the indication of interest. In the design of trials, a thorough evaluation of liver-related problems should be built into the assessments performed.
All of the above considerations lead into to the development of risk management plans. The cumulative information of risk culminates in the risk information necessary for registration of drugs. In addition, the assembly and evaluation of adverse events, serious adverse events, and adverse events of special interest leads to activities toward the development of the core safety information that characterizes the safety of a product.
Compliance with reporting requirements of regulatory authorities is essential.