Pharmaceutical companies spend billions of dollars each year researching and developing newer and ever more effective drugs for treating illnesses ranging from the flu to cancer and heart disease. Years, and even decades are spent advancing a prospective drug through a system that requires very strict adherence to safety and efficacy protocols. Once a new treatment has been deemed safe for use in human patients, the final stages of development are always through clinical studies.
Before a new pharmaceutical can be introduced to the general public, clinical studies are required in order to establish that the drug is not only completely harmless, but truly effective as well. These studies are often carried out in phases, starting with a small group of patients expanding to larger numbers with each new phase. Because this is often a lengthy, time-consuming process, the cost of performing such studies can be exceptionally high. In order to recoup the money spent on these trials, it is common practice for a pharmaceutical company to maintain legal rights to their products for many years in order to corner the market for as long as possible.
There are a variety of different types of studies that can be conducted when developing new pharmaceuticals. Prevention trials are designed to discover ways to keep a person from contracting a disease and often include combinations of drugs, vaccines and in some cases recommended lifestyle adjustments. Treatment trials are intended to investigate new drug treatment therapies for people that are currently dealing with a health issue. These studies often include experimental drugs and are what most everyone thinks of when they hear the term “clinical studies”. Other types of studies can include screening trials, designed to find better ways to detect a disease; and diagnostic trials, designed to develop better ways of diagnosing health problems.
Because the well-being of human patients is of paramount importance, and because in many of these trials there are literally billions of dollars at stake, pharmaceutical studies are always closely monitored. This is done in order to ensure that every trial is conducted in an ethically responsible manner, and that all safety protocols are strictly adhered too. Part of maintaining proper ethics is ensuring that any and all patients have been adequately informed as to what the drug is, what it does and all possible side effects. This is called “informed consent” and every patient is required to sign a consent form indicating that they have been given all the necessary information.
Safety is extremely important in these clinical studies. This is one of the primary reasons that patients are screened before being accepted as subjects. Pregnant women are almost always excluded from such studies, and occasionally their companion too because of the risk to any potential children. Government controlled regulatory agencies are almost always involved in these studies and their guidelines must be followed exactly.
Anyone that is interested in participating in any clinical trial should take the time to research the process before volunteering. Experts recommend talking to friends and family members, as well as seeking out opinions from people that have themselves been a subject of these trials before deciding to proceed.