Introduction to Clinical Trials
What is a Clinical Trial?
A clinical trial is a research study designed to answer specific questions about new therapies or new ways of using marketed treatments. Clinical trials are used to determine whether new medications or treatments are both safe and effective. While in a clinical trial, participants are seen regularly by the research staff to monitor their health and to determine the effectiveness of their treatment. Coordinators are available at all times to handle questions or problems that may arise.
Four Phases of Clinical Trials
The clinical research testing of a new investigational drug is done in four phases before being ready for consideration for FDA approval.
Phase I: Safety - A Phase I study is a small safety study on healthy volunteers. It tests the safe dose range as well as adverse effects of the investigational drug. The primary concern of a Phase I study is safety of the drug being studied. Usual enrollment is between 20 and 100 people for the study.
Phase II: Efficacy – the focus of a Phase II study is primarily efficacy. It usually consists of double-blind studies using a placebo vs. the actual drug. The purpose of Phase II is to determine whether or not the investigational drug demonstrates efficacy for the study’s proposed indication. This phase of the study involves more volunteers than Phase I; up to two or three hundred can be part of this group.
Phase III: Long-term safety and efficacy. Phase III provides adequate information or data regarding the product’s launch into market. Before any outreach of the investigational drug can be considered to the public, a Phase III study with thousands of people representing those who would actually use the drug occurs and concludes the medicine’s effectiveness, benefits, and possible side effects. Once a Phase III study is successfully completed, a drug company can request FDA approval for marketing the medicine.
Phase IV: Phase IV studies are those done after approval to market the drug, often to determine additional information about the safety or efficacy profile of the drug.
There are great benefits to participating in clinical trials. Your participation allows you to:
- Take an active role in your own healthcare
- Gain access to investigational treatments that are not available to the public
- Obtain free expert medical care at leading healthcare facilities during the trial
- Help others by contributing to medical research
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