About Clinical Research Trials
What is a clinical trial?
A clinical trial is a research study involving human volunteers designed to answer specific questions about health issues. Clinical trials can:
- Test new treatments for safety and effectiveness.
- Search for ways to help or improve an illness or health problem
What happens in a clinical trial?
The clinical trial process depends on the kind of trial being conducted. The clinical trial team generally includes doctors, nurses and other research staff. The research staff will check your health, give specific instructions for being in the trial, watch over the participants carefully during the trial, and stay in touch for a period of time after the trial is finished. Some clinical trials have more tests and clinic visits than you normally would have for an illness or health problem.
What are the “phases” of clinical trials?
Clinical trials are conducted in phases. The trials at each phase have a different purpose and help scientists answer different questions.
Phase I
Researchers test a new drug or treatment in a small group of people (20-80) for the first time to evaluate its safety, identify the maximum tolerated dose, find a safe dosage range and identify side effects.
Phase II
The drug or treatment is given to a larger group of people (100-300) to see if it is effective and to further evaluate its safety.
Phase III
The drug or treatment is given to large groups of people (1,000-3,000) to confirm its effectiveness, monitor side effects, compare it to commonly used treatments and collect information that will allow the drug or treatment to be used safely.
Phase IV
During this phase, investigators are looking for additional information, including the drug or treatment's risks, benefits, and optimal use. This may occur after the drug or treatment has been approved for use by the FDA.
What are the different types of clinical trials?
- Treatment trials test new treatments, new combinations of drugs, or new devices and other therapies.
- Prevention trials look for better ways to prevent disease in people who have never had the disease or to prevent a disease from returning. These may include medicines, vaccines, or lifestyle changes.
- Diagnostic trials are conducted to find better tests or procedures for diagnosing a particular disease or condition.
- Screening trials test the best way to detect certain diseases or health conditions.
- Quality of Life trials explore ways to improve comfort and the quality of life for individuals with certain illnesses.
Who sponsors clinical trials?
Clinical trials are sponsored or funded by a variety of organizations or individuals such as pharmaceutical and medical device companies, hospitals, universities, and various Federal Government agencies like the National Institutes of Health (NIH). Trials can take place in a variety of locations, such as hospitals, universities, doctors' offices, or community clinics.