Should I Join a Trial?
As a volunteer in a clinical trial, you are participating in the development of medical therapies - therapies that may offer better treatments and even cures for life-threatening and chronic diseases.
People volunteer to participate in a clinical trial for a number of reasons. You may get involved in a trial because you simply want to help in the advancement of science. Or you may be suffering from a disease for which a good treatment does not currently exist. You may join a clinical trial hoping to improve the medical care you receive. If you do not have health insurance, clinical trials are a way to receive study-related medical care.
Whatever reason, you may have questions about clinical trials and drug research. This FAQ answers some of your questions. You should also ask your physician an your research center's staff any questions before you volunteer. A list of common questions to ask is provided at www.centerwatch.com and CISCRP.
It's important that you make an informed choice about volunteering for a clinical trial.
What is a Clinical Trial?
A clinical trial is a carefully designed study that involves people like you who volunteer to receive investigational treatments under close supervision by a physician and other research professionals. Pharmaceutical and biotechnology companies have developed these treatments. These companies have then selected physicians, also called investigators, who are qualified to conduct clinical trials. It is through these trials that investigational drugs may show their benefits.
All clinical trials are independently reviewed by Institutional Review Boards (IRBs).
IRBs are independent committees whose job is to make sure your rights are fully protected and that you are not exposed to any unnecessary risks. IRBs also are responsible for ensuring you sign a consent form before agreeing to participate in a trial. Clinical trials usually are conducted in three phases (I, II, III). A small number of people participate in Phase I trials. Each later phase involves a larger number of people.
In a clinical trial, a volunteer is usually assigned a specific study group. Sometimes volunteers in one study group will receive an investigational treatment or study drug. Sometimes volunteers will receive a placebo or a treatment already available.
A placebo is an inactive product used as a basis of comparison for the results of the study drug. You, your physician and your research staff may not know who is receiving a placebo and who is not. In this way, volunteers in a clinical trial can be observed by the physician and research staff more fairly. Whether you receive the placebo or the investigational drug, the level of medical attention and care that your receive is the same.
What Can I Expect?
Once you have enrolled in a study, you will receive a physical examination. Your study physician or a research staff member will review your medical history as well. A detailed description of your specific clinical trial and what's expected of you will be outlined in your consent form.
Physicians and healthcare professionals who conduct clinical trials are committed to providing you with quality patient care and medical attention. You should feel free to discuss your medical treatment with your investigator or a research staff member at any time during the course of your clinical trial.
It's important that you take all your medication as prescribed, that you keep all of your scheduled visits, and that you answer your investigator's questions regarding how you feel and whether you've been taking your medication at the scheduled times.
Many study volunteers appreciate the medical attention that they receive when they participate. Your study investigator needs to record any symptoms no matter how minor they may seem to you. If you miss your medication or you haven't taken it on schedule, tell your physician or the research staff. Your input is valuable and important.
When you participate in a clinical trial, complete confidentiality and privacy cannot be guaranteed. Your medical records and your signed consent form will be looked at and even copied for research and regulatory purposes. Information from the study will be given to the Food and Drug Administration (FDA) and to other government agencies in countries where the drug is being considered for approval. The results of the research study may also be presented at meetings or in publications. Your identity will not be disclosed in those presentations.
As a volunteer, you have the right to leave your study at any time and for any reason.
What Happens After the Trial?
When a clinical trial ends, several things might happen. For a serious illness, a pharmaceutical company might continue to provide the study medication to those patients who are responding well. On some occasions, a patient will stop receiving the investigational treatment. In this case, a patient may have to wait for the drug to become available to the public.
After a study is complete, all of the information is collected and analyzed. This information determines whether a study drug is working, whether it is safe and whether it has any side effects. Medical advisors and specialists closely review this data before approving any drug.
Even after a drug is approved, pharmaceutical companies will continue to conduct studies that compare the new drug - in terms of its safety, effectiveness and cost - to other drugs already on the market. Other research studies may determine if a therapy can be administered to children or special populations. And some studies assess a drug's long-term effectiveness and its impact on the quality of a person's life.
Without volunteers, there would be no new drugs to fight diseases and ailments.