Every day, our health care providers are able to prescribe medications and/or treatments that have the potential to improve our lives and make us healthy. Before medications and/or treatments are approved, they must go through several phases of clinical research studies to ensure they are safe and effective for use in the general population. The Center for Information and Study on Clinical Research Participation (CISCRP) refers to clinical research participants as “medical heroes” for they write that “it is said that the greatest gift is one which is given anonymously, giving when you do not know whether you will get direct personal benefit. This is the gift that you have given by taking part in clinical research.”
Since 1997, when Virginia Women’s Center was first chosen as a clinical research site, we have received a tremendous response from our patients that has enabled us to participate in over 50 studies which have contributed to the safety and effectiveness of medicine for women. We commend and thank all of our past “medical heroes” and encourage you to learn more about how your participation in clinical research can benefit the future of medicine for women. Below are some frequently asked questions to help you learn more about clinical research studies.
Q. What is a clinical trial?
A. A clinical trial is a research study carefully designed to answer specific questions about vaccines, new medications or new ways of using known medications. Clinical trials measure the medication’s ability to treat a medical condition and how safe it is to use. The FDA (U.S. Food and Drug Administration) has strict rules by which all clinical trials must be conducted. The FDA then looks at the results of the studies to decide whether to approve them for use by the general public.
Q. What are the different types of clinical trials?
A. There are different kinds of trials based on the purpose for the trial.
- Treatment trials: test experimental treatments, new combinations of drugs or new approaches to radiation or therapy
- Prevention trials: test better ways to prevent disease or to keep it from returning; may include medicines, vaccines, vitamins or lifestyle changes
- Diagnostic trials: test better procedures for diagnosing a certain disease or condition
- Screening trials: test the best way to detect certain diseases or health conditions
- Quality of life trials: test different ways to improve the quality of life of those suffering from a chronic illness
Q. What are the phases of clinical trials?
A. At Virginia Women’s Center, the majority of the studies conducted are either Phase II or Phase III.
- Phase I: Researchers test the new study drug/treatment in a group of 20-80 people for the first time to evaluate safety, determine a safe dosage range and identify side effects.
- Phase II: Researchers test the study drug/treatment in a group of 100-300 people to see if it is effective and to further evaluate its safety.
- Phase III: Researchers test the study drug/treatment in a group of 1,000-3,000 people 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: Post marketing studies delineate additional information including the drug’s risks, benefits and optimal use.
Q. How long do clinical studies last?
A. Phase I studies typically last only a couple of weeks. Phase II-III studies, like the ones at Virginia Women’s Center, can take anywhere from several months to several years.
Q. How can I learn more about clinical research studies at Virginia Women’s Center?
A. Use the links below to learn more. You can also contact a clinical research coordinator at 804.662.6117 or send a secure message on our patient portal to learn more or express interest in participating in one of our current studies.
- Learn about our clinical research studies that are currently enrolling
- Get to know our clinical research team
- Read frequently asked questions about participating in a study
- Read a patient testimonial from one of our past participants
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