Clinical Trials

One aspect that all pharmaceutical litigations must address are the clinical trials related to a drug. The FDA has a rigorous set of statues and regulations that companies must follow in order to bring a drug to market. Clinical trials are a crucial part of this process.

A clinical trial is the first time that a drug is being test on human subjects. For each drug, numerous clinical trials are conducted. Starting with Phase 1 trials on healthy subjects, through Phase 3 trials conducted on subjects the drug is intended to treat. The trials are each governed by trial specific protocols that methodically outline the exact parameters of the trial. Subjects are then chosen based on the certain criteria laid out in the protocol. The trial then commences per protocol. Once the trial is concluded a wealth of information can be gleaned from the resulting data. This data is then translated into a statistical analysis. The statistical analysis addresses many aspects from pharmokinects to the likely hood of certain adverse events. At this point, many different complex statically concepts come into play such as statistical power and statistical significance. 

Clinical Studies

Clinical studies are actually a different class of clinical analysis from a clinical trial. A clinical study typically refers to an observational study or an epidemiology study. An observational study is typical conducted on a pool of subjects that have been prescribed the drug once it is on the market. These studies are conducted for a longer duration and contain more subjects than a clinical trial. An epidemiology study is a retrospective study conducted on a database from a healthcare insurer/provider or a national database. These studies are crucial in a pharmaceutical litigation where the adverse event is considered to be a rare endpoint disease/event.