About Clinical Trials:
- A research study involving human volunteers to answer specific health questions.
- Carefully conducted clinical trials are the safest and fastest way to find treatments that work in people and new ways to improve health.
- Clinical trials are conducted according to a plan called a protocol.
- A protocol describes what types of patients may enter the study; schedules of tests and procedures, drugs, dosages and length of study, as well as outcomes that will be measured.
- Each person participating in the study must agree to follow the protocol.
Why are clinical trials conducted?
- To see if a new drug or device is safe and effective for people to use.
- To compare existing treatments to determine which is better.
- To study different ways to use standard (approved) treatments, so they will be more effective, easier to use and/or decrease side effects.
- To learn how to best use the treatment in a different population, such as children, in whom the treatment was not previously tested.
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.
- In Phase I trials, researchers test a new drug or treatment in a small group of people (20 - 80) for the first time to evaluate its safety, determine a safe dosage range and identify side effects.
- In Phase II trials, the study 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, determine a safe dosage rand and identify side effects.
- In Phase III trials, the study drug or treatment is given to larger groups of people (1,000 – 20,000) to confirm its effectiveness, monitor treatments and collect information that will allow the drug or treatment to be used safely.
- In Phase IV trials, post marketing studies gather additional information including the drug’s risks, benefits and optimal use.
What are some of the possible benefits of my participation?
- Gain access to potentially new research treatments.
- Receive expert medical care for the condition being studied, since investigators are often specialists in the disease being studied.
- Help others by contributing to medical research and treatment advances.
- Safety, determine a safe dosage range and identify side effects.
What are some of the possible risks of my participation?
- There may be unpleasant, serious, or even life threatening side effects resulting from the treatment.
- The treatment may not be effective.
- Participation in the trial may be demanding and time consuming.
How Volunteers are Protected
NONDISCRIMINATION NOTICE STATEMENT
West Tennessee Healthcare (WTH) does not exclude, deny benefits to, or otherwise discriminate
against any person on the grounds of race, color, national origin, age, religion, disability,
Limited English Proficiency or sex, including discrimination based on gender identity, sexual
orientation, sex stereotyping or pregnancy in admission to, participation in, or receipt of the
services and benefits under any of its programs and activities, whether carried out by WTH directly
or through a contractor or any other entity with which WTH arranges to carry out its programs and
For further information about this policy, contact Amy Garner (731) 541-9914.