Clinical studies examine the efficacy and safety of possible new medications. They are conducted with volunteer patients who receive the medication or, depending on the study, a placebo that contains no active medication. This allows researchers to compare any changes in patients who receive the new medication to those in similar patients who do not receive the medication.
Although there are different types of clinical studies, all must follow the Good Clinical Practices set by regulatory agencies such as the FDA in the United States and the EMA in Europe. These rules help protect the rights and safety of people who volunteer to participate.
Clinical Study Phases
Clinical studies are conducted in phases. Each of these phases has specific goals.
These are the first human studies of a new medication and usually involve a small number of patients. Researchers evaluate the medication’s safety, determine a safe dosage range, and monitor participants for potential side effects.
These usually involve more patients than Phase 1 studies. Researchers evaluate the efficacy of the medication and continue to evaluate safety.
These studies involve an even higher number of patients. Researchers confirm the efficacy of a medication, monitor its side effects, and compare it to commonly used medications.
These are also called post-marketing studies because they are conducted after a medication is approved and on the market. They provide longer-term information about a medication’s risks and benefits.