Does volunteering for a clinical trial make sense for you? The following information will help you to decide.
What is a clinical trial?
A clinical trial is a scientific study done in human volunteers to test the safety, value and the side effects of a procedure, medication or device. All of the steps that will be followed in the trial are set out in the study protocol. The protocol is a detailed "recipe' for how the study will be done. A study may show that the tested treatment is better than, as good as, or no better than the standard treatment for the same condition. Without clinical trials there would be few if any medical advances - advances that help us to treat millions of people and future generations worldwide who have various illnesses.
Why do we need clinical trials?
A series of clinical trials for each possible treatment must be done before the Food and Drug Administration (FDA) will approve a drug, procedure or device. Many of the trials done at MedStar Health Research Institute are trials testing possible drugs or devices. A drug must be shown to be safe and useful for public use before the FDA can approve it. From the lab bench to the drug store, developing a new drug is a long and expensive process. It is estimated to take about 10 years and 800 million dollars to bring one new drug to market (R & D Directions, January 2002).
Who can participate in a clinical trial?
People with the condition being studied or healthy people can volunteer to take part in a clinical trial. Each study has specific entry requirements such as age or a medical condition necessary for participation. The doctor in charge of the study must review the volunteers' medical history to determine if he/she is eligible to participate based on strict study conditions called entry criteria
Who is in charge of a clinical trial?
A medical doctor is usually responsible for carrying out the study according to the study protocol. Before a clinical trial can begin to enroll volunteers an Institutional Review Board (IRB) must approve it. The IRB is a committee made up of healthcare experts that review each study to protect patient rights and ensure the safety of research volunteers. The IRB also ensures the research is scientifically sound and is involved in the review of safety issues throughout the study.
What is informed consent?
One of the documents the IRB must review and approve is called an Informed Consent Form. This is provided to volunteers who are interested in participating in a clinical trial program. The informed consent includes everything a volunteer needs to know about the study so that he/she can make an informed decision as to whether or not to participate. The process allows volunteers to ask questions. Volunteers are encouraged to take their time in making a decision before signing the consent and joining the study. You and your family should feel completely comfortable with your decision to participate before you sign the consent.
What are the benefits to being in a clinical trial?
Once enrolled in a clinical trial, many volunteers find there are a number of potential benefits to participation. These can include:
- The opportunity to become involved in the testing of a new drug that may have potential to improve your condition.
- Close contact with the study team for management of your disease.
- Contributing to medical science, which may help others now and in the future.
However, volunteers understand that there may not be any benefit to participating in a study.
6525 Belcrest Rd, Suite 700
Hyattsville, MD 20782
To find out more about clinical trials taking place at the MedStar Health Research Institute, please call 301-560-7300.