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An Overview of the Phases of Clinical Trials

May 25, 2017

Whether you need treatment for acne, rosacea, dermatitis, actinic keratosis, or another skin condition, many of the treatment options that your dermatologist may recommend went through a research process before being prescribed to patients. Continue reading to learn about the phases of clinical trials.

Pre-Clinical Development

Pre-clinical development refers to an early stage of the discovery of a new medicine. This stage of a clinical trial is commonly associated with animal research.

Phase 1

In Phase 1, between 20 and 100 people with the skin condition or disease, as well as healthy volunteers, participate in the trial. This stage lasts for several months, and its purpose is to determine a drug’s safety and proper dosage. About 70% of drugs move beyond Phase 1.

Phase 2

Phase 2 of a clinical trial can last between several months and two years, and the purpose of this stage is to study a drug’s effectiveness and side effects. As many as several hundred patients with the condition participate during this phase, and approximately 33% of medications move to Phase 3.

Phase 3

The purpose of this stage is to determine the efficacy of the drug and to monitor adverse reactions. In Phase 3, information is collected from a larger group of patients, and this phase provides researchers with most of a trial’s safety data. Between 300 and 3,000 volunteers who have been diagnosed with the skin condition participate in the trial. The length of this phase can range from one to four years, and approximately 25-30% of drugs move beyond this stage.

Phase 4

Finally, once a drug has been FDA-approved following Post-Market Safety Monitoring, Phase 4 trials are conducted to further examine the medicine’s safety and efficacy. This stage involves several thousand volunteer patients who are affected by the condition or disease.

Are you interested in seeing a dermatologist in Arlington Heights about clinical trial participation? If so, then please call Arlington Dermatology at [company-phone id=1] for information about our current research.

doctor examining patient