Not every clinical study is the same. From different conditions to different phases, there are many variables that go into each study.
According to clinicaltrials.gov, a clinical study involves research using human volunteers (also called participants) that is intended to add to medical knowledge. In a clinical trial, participants may receive different medical products like drugs or devices, different procedures, or a behavior change, like a diet. Some trials compare new medical approaches to ones that currently exist, or to a placebo.
Clinical trials are conducted in different phases. Each phase in a trial serves a different purpose and will have different requirements for study volunteers.
Phase 1 trials last for several months. 20-100 healthy volunteers or those with the disease condition take part in this phase with the purpose being safety and finding appropriate dosage. Approximately 70% of drugs will move on from phase 1 trials to the next phase.
Phase 2 trials are meant to test the safety and efficacy of certain treatments and can last from several months up to 2 years. Several hundred people with the condition will take part in phase 2 trials.
Phase 3 trials test the safety of the specific treatment and monitor for any adverse reactions. As many as 3,000 volunteers may participate in phase 3 trials, which can last 1-4 years. Approximately 25-30% of drugs will move on to the next phase.
Phase 4 trials consist of several thousands of volunteers with the disease or condition and test the safety and efficacy of the treatment. Phase 4 trials are conducted once the new treatment has been approved by the FDA.
Clinical trials are designed to answer specific questions related to medical drugs or devices. While there are many differences from early small-scale studies, to later large-scale studies, there is always one common goal in mind: furthering medical research.
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