About Clinical Trials
Sutter Health Sacramento Sierra Region

Clinical trials are carefully designed, rigorously monitored studies that allow medical professionals to test promising new approaches to care. There are different types of studies to test the effectiveness of all aspects of care:

• Screening Trials - can include anything from questionnaires to blood tests to determine if participants have, or are likely to develop a particular condition
• Diagnostic Trials - includes new imaging technology, scopes, laboratory tests, as well as new uses for existing tools. Trials are generally conducted with participants known to have or suspected to have a particular condition
• Medical Device Trials - can include any medical device used on the body or within the body to treat a condition. Such devices can include anything from artificial joints to lasers to blood vessel stents that open clogged arteries.
• Pharmaceutical Trials - testing the effectiveness of new drugs or drugs used at different doses than approved by the FDA or for new purposes (i.e., using antibiotics to treat Alzheimer's). See explanation of phases [link] below.
• Surgical Trials - testing new, expanded or combined surgical approaches such as testing the effectiveness of a noninvasive surgical approach (i.e., laparoscopic) versus a traditional approach.
• Combination Trials - many trials test the effectiveness of a drug treatment with a surgical approach, or a medical device with a drug (see medicated stent case history) or another combination of the above categories.
• Prevention Trials - trials that look for ways to prevent participants from developing a condition or to prevent a recurrence of a condition. Lifestyle changes, nutrition, drugs, vitamins, vaccines or mineral supplements may be included.
• Quality of Life Trials - for participants with a chronic condition or a disease with no known cure. Trials search for ways to improve participant's lives through pain management, tools for mobility, nutrition or other methods.

SIMR is most commonly involved in trials for screening, diagnostics, medical devices, Phase III and Phase IV pharmaceuticals, prevention and quality of life.

Pharmaceutical Trial Phases

According to the National Institutes of Health (NIH) Web site www.clinicaltrials.gov:

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.
• In Phase III trials, the study 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.
• In Phase IV trials, post-marketing studies delineate additional information including the drug's risks, benefits, and optimal use.