Clinical Trial Participant Questions

There are two main types of clinical studies: clinical trials (also called interventional studies) and observational studies. Both types investigate how to improve people’s health by finding better ways to prevent, detect and treat diseases. Studies test interventions like new or existing drugs, surgical procedures, medical devices or beneficial activities and habits. The main difference is clinical trial participants are assigned specific interventions, whereas observational study participants are not.

As a research participant, you help advance medical knowledge that can improve care and benefit others. If you have an illness or disease, participating in a study can give you access to new, investigational treatments. You’ll also receive added care and attention from the clinical trial staff.

Each clinical study has unique eligibility criteria. This helps keep you safe and ensures that the scientists can study their specific research question. Eligibility criteria may include:

• Age
• Sexual orientation
• Location
• Prior treatments
• Stage of disease

If you’re interested in enrolling in a clinical trial at Sutter, contact us at clinicalresearch@sutterhealth.org. You may also need to undergo screening tests or procedures to determine if you’re eligible.
 

Clinical trials are conducted in several phases:

• Preclinical tests: Before clinical trials involving humans are conducted, potential treatments are first assessed in preclinical research. For example, the research may aim to learn if a drug or device is safe or harmful to humans. 
• Phase 0: These studies are the first clinical trials conducted in humans. They aim to learn how a drug is processed in the body and how it affects humans. In these trials, a very small dose of a drug is given to about 10 to 15 people.
• Phase 1: These studies assess the safety and the effects of a drug or device in humans. This phase of testing, which can take several months to complete, usually includes a small number of healthy study participants (20 to 100 people).
• Phase 2: These test the effectiveness of a drug or device over several months to two years and involve up to several hundred people. Most Phase II drug studies are randomized trials where one group of patients receives an experimental drug, while a second control group receives a standard treatment or placebo. Often these studies are blinded, meaning neither the study participants nor the researchers know who has received the experimental drug or other intervention.
• Phase 3: These studies involve randomized and blind testing in several hundred to several thousand study participants. This large-scale testing, which can last several years, seeks to understand the effectiveness, benefits, and adverse reactions or side effects of the drug or device.
• Phase 4: These studies, often called Post Marketing Surveillance Trials, are conducted after a drug or device has been approved for consumer use.

We do everything we can to minimize risks and keep you safe. However, clinical research may involve some risks. These can include side effects or health problems, not receiving the intervention being tested in the clinical trial, or the intervention not working as well as standard treatment. Taking part in research can also take more time than your regular care. The study investigator will discuss risks with you before you enroll to make sure the study is right for you.

Your safety is our top priority. We follow U.S. agency guidelines for research studies to protect your health. At Sutter, we also have an Institutional Review Board (IRB) that reviews, approves and monitors research involving patients. The IRB is comprised of doctors, researchers, subject matter experts and members of the community. This team of specialists work together to ensure that studies are ethical and that your rights and welfare are protected.

Informed consent is a process that ensures you understand the key facts about a clinical trial before you decide to participate. During this process, the study investigator will explain the risks and benefits of the study, and you’ll have a chance to ask questions.

If you’re a good fit for the study and want to move forward, you’ll be asked to sign a consent form. This form will include details about the study, including its purpose, duration, required procedures, risks and benefits, and who to contact for support or questions. You must sign the form if you want to enroll in the study.

After a Phase 1 or 2 trial, the U.S. Food and Drug Administration (FDA) decides whether the research should progress to the next phase. After a Phase 3 trial, the FDA decides whether there is enough data to demonstrate that the new treatment is safe and effective. If there is, the new approach may become a new standard of medical practice. Even if the FDA doesn’t approve the treatment for clinical use, the results may still have medical importance and inform future research.

Results from clinical trials are often published in peer-reviewed scientific journals. View published papers by Sutter scientists , or search for a study by its official name or Protocol ID number in the National Library of Medicine's PubMed® database.