Red Hot Mamas provides information on clinical trials taking place throughout the United States. Clinical trials are tests conducted to study the safety and effectiveness of new treatment options or to determine if a drug that is currently available for sale can be utilized for the treatment of a new disease or at different doses. Patient volunteers are recruited for each trial, and in most cases, the treatment, office visits and tests are free of charge.

Upon approval by an Institutional Review Board (IRB), all clinical trials are facilitated through a healthcare facility and monitored by licensed medical professionals. Participating in a clinical trial can provide access to new and innovative treatments, and help to offer other patients beneficial healthcare options in the future.

The clinical testing of drugs in humans is conducted in the four following phases:

Phase I: Typically focused on assessing the drug’s safety and can last up to one year. The study generally involves a small number of healthy volunteers to determine what happens to the drug in the human body.

Phase II: After the safety profile is approved, this study increases its volunteer volume to several hundred and can continue for several years. The Phase Two study tests the efficacy of the drug compared to a current standard treatment, if one is available, and placebo. Volunteers will either receive the drug that is being tested, or the standard treatment or placebo.

Phase III: This last phase can last for five years or so and will include the largest number of volunteers. In this study, the drug is tested for a very comprehensive understanding of its effectiveness, benefits and possible side effects.

Once these studies are completed, the results are submitted to the FDA (Food and Drug Administration) for approval to bring the drug to market.

Phase IV: This study phase is not widely used, but is designed to provide more detailed information about the dose of a new treatment or to look at side effects in more detail. In addition, this study phase is sometimes used to compare a drug with other drugs already on the market or to determine the cost-effectiveness of the therapy relative to other products.

Learn more about clinical trials:

Types of Studies

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