Research has always been an integral and congressionally-mandated part of the health care mission of the U.S. Department of Veterans Affairs. The VA is a recognized leader in research related to diseases and conditions affecting veterans, which also benefits health care for the general population. Many of the research studies at the VA involve clinical trials in which veterans can participate by partnering with researchers to test new drugs, devices and techniques in humans after testing in the laboratory has been completed. The willingness of veterans to volunteer as subjects for these studies serves to advance veteran health and maintain state-of-the-art care for patients within the VA healthcare system.
Hundreds of clinical trials have been performed here in the past and we are grateful to all the patients who have volunteered to participate in clinical trials over the years and to those of you who will be a part of such studies in the future.
This section of our website contains answers to some questions veterans, their families or others may have about VA research. We encourage you to read this information and consider the possibility of volunteering for a clinical trial.
Our veterans volunteer for many reasons. Most do it purely for altruistic reasons - they just want to contribute to bringing improved medical care to other veterans, their families and the general public. Some of our patients have chronic and life-threatening illnesses and take part in clinical trials to gain early access to promising new therapies. In some cases, they view a clinical trial as their best hope for relief or a cure.
If you are considering volunteering for a clinical trial, it is essential that you become informed. You must weigh the risks against the benefits and keep in mind that a clinical trial is an experiment.
WHO SPONSORS CLINICAL TRIALS?
Private companies sponsor nearly all clinical trials although the VA or other research foundations or government agencies (e.g., National Institutes of Health and Department of Defense) sponsor some. Some trials involve experimental drugs that have not yet been approved by the FDA (Food and Drug Administration) for use by the general public. In other trials, experiments are designed to learn more about drugs that are already approved by the FDA.
WHO PROTECTS YOUR RIGHTS?
In the United States, all clinical trials must be conducted with the approval of the Institutional Review Board (IRB), also known in the VA as the Human Studies Subcommittee (HSS). This Committee serves as the patients' advocate and protects the rights and privacy of patients participating in clinical trials. The IRB reviews the study methods to determine if there is a sound scientific basis and to ensure that risks to volunteers are minimized. It also ensures that the written informed consent document accurately informs the patient of the nature of the study. The IRB monitors the clinical trial as long as there are patients actively participating in the study.
WHAT IS INFORMED CONSENT?
Along with the opportunity to ask questions and discuss your concerns, it is the written document that describes the study in plain language and gives information about the expected effects of the drug. You should not sign this form until you have had all your questions completely answered to your satisfaction. When you sign the form, it documents to the IRB and the FDA that you understand what the study is about, have been informed and understand the risks, that you understand you may have other treatment options, and that you have the right to leave the study at any time.
WHAT ARE THE RISKS?
The clinical testing process is done in a way to minimize risks to volunteers. However, no clinical trial is without some risk and it is important to remember that clinical trials are experiments designed to find out if the drug works and identify side effects. Before a drug can be tested in humans the sponsoring company must have conducted extensive laboratory and animal testing, which provides information about whether the drug is toxic to human cells and how well it is tolerated by animals at certain dosages.
Testing in humans is done in three phases with the approval and oversight of the Food and Drug Administration. Phase 1 studies assess the safety of a drug and usually involve less than 100 healthy volunteers who are paid for their participation. Phase 1 studies help researchers understand what happens to the drug in the body - how it is absorbed, metabolized, and excreted.
Next, Phase 2 studies test the new drug in a few hundred people who have the targeted disease. About one-half of all drugs in Phase 2 successfully complete this stage. When drugs fail in Phase 2 it's usually because they don't appear to be effective in treating the disease or the side effects are too serious or severe.
If the company has preliminary evidence from Phase 2 testing that the new drug may provide a therapeutic benefit and has a good understanding of the short-term side effects, a Phase 3 study may begin, usually involving hundreds to thousands of volunteers in order to generate enough information to allow the company to seek FDA approval to market the drug.
The VA primarily conducts Phase 2 and 3 trials. The greatest risk to volunteers is unexpected side effects, which are most likely to occur in Phase 2 trials. Therefore, before volunteering, learn whether the trial is a Phase 2 or 3 and decide whether the risks are acceptable to you.
WILL YOU GET THE SUGAR PILL OR THE NEW INVESTIGATIONAL DRUG?
In most studies, patients are assigned by lottery to either the experimental drug group or the placebo group. So, if you are considering participation in a clinical trial because you hope to get access to the new treatment, it is important that you understand that you may or may not be treated with the experimental drug. You may get what is known as placebo (sometimes called the sugar pill even though it isn't sugar). Quite often, even your doctor won't know if you are receiving the placebo or the real drug. You should also know that after the study ends, you most likely will not be able to continue to have access to the new drug until, and if, it is determined to be effective and is approved by the FDA for regular use.
Participating in a clinical trial can have some drawbacks. The study will take some extra time and effort. For example, you may need to make extra trips to the VA to see your doctor or study coordinator. You may need to have your blood drawn more frequently or be required to wear monitoring equipment. You may have to be taken off other medications during the period of the study. These are some of the elements that you must fully understand and discuss with your doctor before you make the commitment to participate in a research study.
HOW DO I KNOW WHAT STUDIES NEED VOLUNTEERS?
You can ask your doctor about ongoing trials. If you wish, you can also contact the CARES Administrative Office at (708) 343-6300.
More information about volunteering in VA research studies can be found at the following website: