Volunteer to be part of a Clinical Study
Solano Clinical Research is located in the Northern California city of Vallejo in Solano County. If you are located in Solano, Contra Costa, Sonoma or Napa counties, you could be eligible to participate in a study at Solano Clinical Research. View our current clinical studies.
Are you interested in learning more about participating as a volunteer for a clinical study in dermatology, vaccines or women's health? We are happy to answer your questions - please call us at (877) 449-7546 ext. 223.
FAQs: volunteering for Clinical Trials
What is a clinical trial or clinical study?
The FDA defines "Clinical Trial" as the scientific term for a test or study of a drug or medical device in people. These tests are done to see if the product is safe and effective for people to use. Doctors and other health professionals run the tests according to strict rules set by the Food and Drug Administration (FDA). FDA sets the rules to make sure that people who agree to be in the studies are treated as safely as possible.
Are clinical studies safe?
Before a prospective treatment is tested on humans, it is thoroughly tested through laboratory and model studies to determine if it's safe. The tests are run by health professionals and doctors according to strict rules set by the Food and Drug Administration (FDA). FDA sets the rules to make sure that people who agree to be in the studies are treated as safely as possible. Before a clinical trial can begin, an IRB (Institutional Review Board) reviews and approves the trial protocol. This includes looking at the informed consent and volunteer selection processes, as well as other benefits and risks of participation.
Why does the FDA encourage women and minorities to participate in clinical trials?
Sometimes drugs work differently in men and women, and in people from varying ethnicities, such as African Americans, Hispanics/Latinos, American Indians, Asians, and Pacific Islanders. The FDA wants people from many different groups included in these studies because in the past, most drug testing had been done on white men.
What is a "Phase"?
Clinical studies are done in phases.
Phase I
Phase 1 studies include only a few healthy people. Here, scientists find the best way to give a new treatment and how much they can safely give, and identify side effects.
Phase II
Phase II studies include the people have disease that the product is going to treat. In this larger group of people, researchers try to see how well the product works against the disease.
Phase III
If Phase II is successful, the study moves into Phase III which includes large numbers of patients with the disease. In this Phase, the drug or treatment's effectiveness is confirmed, side effects are monitored, and it is compared to standard treatments for the disease.
Phase IV
Phase IV studies may occur after FDA approval. Additional information regarding risks, benefits, and optimal use is gathered by researchers.
What do I need to know before I decide to be part of a clinical study?
Before making your decision, the FDA recommends asking the following questions:
- What is the study trying to find out?
- What kinds of test and exams will I have to take while I'm in the study? How much time do these take? What is involved in each test?
- How often does the study require me to go to the doctor or clinic?
- Will I be hospitalized? If so, how often and for how long?
- What are the costs to me? Will my health insurance pay for it?
- What follow-up will there be?
- What will happen at the end of the study?
- What are my other treatment choices? How do they compare with the treatment being studied?
- What side effects can I expect from the treatment being tested? How do they compare with side effects of standard treatment?
- How long will the study last?
What is "informed consent"?
Informed consent means is an FDA requirement that says you must be given complete information about the study before you agree to take part. The FDA requires that you receive and understand the following information:
- The study involves research of an unproven drug or device
- The purpose of the research
- How long the study will take
- What will happen in the study and which parts of the study are experimental
- Possible risks or discomforts
- Possible benefits
- Other procedures or treatments that you might want to consider instead of the treatment being studied
- The FDA may look at study records, but the records will be kept secret
- Whether any medical treatments are available if you are hurt, what those treatments are, where they can be found, and who will pay for the treatment
- The person to contact with questions about the study, your rights, or if you get hurt
- You can quit at any time
Make sure you understand all of the information before you agree to be in the study.
What if I change my mind and no longer want to be in the clinical study?
You can leave the study at any time, for any reason. The informed consent form is NOT a contract.
Who should I contact for more information?
If you would like more information about participating as a volunteer for a clinical study in dermatology, vaccines or women's health, please call (877) 449-7546 ext. 223.