Clinical trials are conducted to understand how well a drug or treatment works to cure or prevent disease. The studies are done in three phases to thoroughly assess the safety and efficacy of the treatment.
Phase I clinical trials are typically designed to evaluate the safety of a drug or other type of medical treatment in healthy volunteers. A phase I trial is run in small numbers of healthy participants, usually around 20-80 volunteers, to make sure that the drug is safe in people. In this phase, trials identify risks and adverse reactions associated with the new medication.
In phase II clinical trials, the new drug is given to a larger group of people who have the disease or condition. The purpose of phase II clinical trials is to gather more data on how the drug works by examining dosage, administration, safety, and efficacy. This phase seeks to maximize the benefits and minimize the risks of the treatment.
Between 300 and 3,000 patients are involved in phase III clinical trials. Moreover, the third phase also includes testing how effective the drug or treatment is in comparison to the existing treatment for the same disease or condition. Phase III clinical trials are required by the FDA before it will approve a new drug, medical device, or procedure.
Phases of clinical trials are vital in the development of new, improved medicines and treatments. Clinical trials are important in providing data that can be used to support approval as well as in helping investigators assess the benefits and risks of drugs and treatments.
If you'd like to participate in our paid clinical trials in Tampa, contact Santos Research Center at (813) 249-9100 or visit www.santosresearch.com.