What is a Clinical Trial?
“Clinical Trial” is 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 test 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.
Why should I participate in research?
The benefits of study participation may include:
- Study-related exams at no cost
- Study medication
- Reimbursement for time and travel expenses
- Contributing to the development of new therapies and learning more about a medical condition and treatment options
How am I Protected?
- Informed Consent: to help you decide if you want to be in a study, FDA requires that you be given complete information about the study before you agree to take part. This is known as informed consent. FDA requires that people be told:
- That 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
- That FDA may look at study records, but the records will be kept secret
- The person to contact with questions about the study, your rights, or if you get hurt
- Informed consents must be written so you can understand it. If you don’t, be sure to ask the doctor or other medical person to explain it. Make sure you understand all of it before you agree to be in the study.
HIPAA Regulations
New privacy regulations ensure privacy protections for patients by protecting medical records and other individually identifiable health information, whether it is on paper, in computers or communicated orally. To learn more, visit www.hipaa.org.
Our Clinical Research Studies:
Medical research or clinical trials are divided into a few different phases. Each phase has a different focus, but all work towards the goal of finding a new or improved treatment. Most of our studies are in Phases 3 and 4.
Phase 3 Studies
A large group of people are involved in Phase 3 studies. Those who participate in Phase 3 are usually randomly assigned to different groups. In one group, up to a few thousand people will receive the new treatment.
Another group receives the standard treatment for the same medical condition, or receives a placebo. This is called the “control” group. The side effects and treatment success in people receiving the new treatment are compared to those in the control group. This helps the researches know if the new treatment is really safer and more effective.
During this phase, researchers will continue to collect information about side effects, and also study how often the condition returns and the effects of the treatment on the patient’s quality and length of life.
After Phase 3 studies are completed, a medicine can be submitted to the government for final approval.
Phase 4 Research Studies
Once a new treatment has been approved, there may be additional clinical studies performed. These are called Phase 4 studies. These studies are conducted for a number of reasons. One of these is to find out how effective the treatment is in different groups of people — such as those of the same race or age group. Another is to see if the treatment can be more effective if administered in a different fashion. For example, a pill can be changed to a topical cream for a more direct approach to muscle/joint pain. Information is also gathered about long-term effects of the treatment.
IRB Protections
Each clinical trial is approved for suitability by an Institutional Review Board (IRB) comprised of professionals from the fields of medicine, religion, law, and education. The IRB’s function serves to protect the safety and rights of volunteers in clinical trials.
For more information, please see the resources below:
The Center for Information and Study on Clinical Research Participation
ClinicalTrials.gov: A service of the U.S. National Institutes of Health
http://www.clinicaltrials.gov/
FDA Information for Patients
http://www.fda.gov/ForConsumers/byAudience/ForPatientAdvocates/default.htm
The Belmont Report
http://www.fda.gov/ohrms/dockets/ac/05/briefing/2005-4178b_09_02_Belmont%20Report.pdf