Questions About Clinical Trials
What is a clinical trial?
Why should I participate in a clinical trial?
Why are clinical trials needed?
What kind of trials are there?
What are the risks?
What does informed consent mean?
What is the role of UVA's Institutional Review Board?
Are there benefits to participating in a clinical trial?
Who will I deal with?
What will I have to do to participate in a clinical trial?
What will happen to me after I enroll in a trial?
How long do clinical trials run?
Will I know the results of the trial?
A clinical trial is a scientific study that tests the effectiveness of a treatment, a device, or a drug. A trial could test, for example, the effectiveness of blood pressure medication in lowering blood pressure or whether a certain drug could decrease cholesterol.
It's a way to help yourself and to help others. It provides an opportunity for you to help increase knowledge by helping researchers find out if a particular drug or therapy is safe and effective. While it is difficult to predict whether your condition will improve or how much it will improve, participation in a trial may be good for your health. It has been shown, for example, that even patients receiving the placebo, the inactive drug (see glossary of useful clinical terms) in clinical trials frequently do better than patients outside of the trials.
Medical science is always looking for better solutions to treat illnesses and diseases. Before a medication or a treatment can be used on a patient, it must be carefully tested in a standardized manner for effectiveness and safety. Most likely, every doctor-prescribed medication that you use was first tested in a clinical trial.
As a major academic medical center, UVA conducts hundreds of clinical trials at any moment. Trials to test drugs, devices or procedures for treatment of illnesses, such as kidney disease, diabetes, heart disease, brain injuries and so on are being conducted here. These trials have several things in common:
- They are supervised by a principal investigator (see glossary).
- They are sponsored by or supported by a researcher, a drug company or a government agency.
- UVA may be one of many sites where the study is being conducted, or it may be the only site.
Can anybody participate in a clinical trial?
This depends on specific research goals of each trial. You must meet the requirements of the trial that you are interested in participating.
There are possible risks, such as adverse events or side effects to consider when participating in any clinical trial. Participants are informed of known risks or side effects before starting the trial. Risks also are explained in the informed consent document. Make sure you fully understand them. There is always the possibility of unknown risk. If any new side effects or risks are discovered during the trial you will be informed.
You must be fully informed, and consent to participate in a clinical trial. Informed consent involves a discussion between you and the investigator or research team member about what is involved in the trial, its purpose, risks, procedures, your compensation, and who you should contact if you have questions. You are encouraged to ask questions during the discussion so you understand what you are signing. Informed consent also requires you to sign and date the consent form.
UVA's Institutional Review Board for Health Sciences Research (IRB-HSR) is comprised of health care professionals and members of the local community. The purpose of this committee is to monitor the safety and protect the rights of human research subjects - or participants in research. The Committee continually reviews clinical trials developments and activities, and risks and benefits.
You may be paid a stipend and/or costs to cover mileage, travel time and meals. Participants may receive free medical care visits for the study, certain free medications, free diagnostic tests, and laboratory procedures and free parking.
Once accepted in a trial, you will meet the principal clinical investigator, the health care provider who is responsible for the trial. Members of the research team you will see on a regular basis include the clinical trials coordinator(s) and research assistant(s).
Clinical trials vary in what they require of a subject, but typically,
- You must make a commitment in time and be willing to follow the directions and instructions of the research team.
- Periodic routine checks generally take ½ hour to two hours. The number of visits and the length of the visits depend on the type of trial.
A typical trial proceeds in several phases:
1. A screening visit.
- The informed consent is reviewed with you.
- Blood is tested.
- Your medical history is taken.
- (Possibly) You have a physical exam to determine if you meet the trial's requirements.
2. A baseline visit (may be combined with the screening visit.
3. Routine study visits are periodic visits throughout the study to test blood, administrate the study drug, and check your condition.
4. Interim visits are added for unexpected problems or extra tests.
It depends on the trial; they can vary from days to a number of months, or even years. You will be told the expected length of the trial before you start. This information is discussed with you during the informed consent process.
Usually, you are informed of the results of tests performed during the trial. You will always be informed of results that might influence your decision to remain or withdraw from the trial. Medical information may not be shared if the study is blinded (see glossary) until the trial is completed.
Your decision to participate in a clinical trial involves many factors, such as transportation, job responsibilities, home responsibilities, and family support. Remember, you are free to change your mind and drop out of the trial at anytime. But most trials require or strongly encourage a safety evaluation (exam and blood test) before you permanently withdraw.