What is a clinical research trial? A clinical research trial is a research study conducted on patient volunteers to evaluate a new medical treatment, drug or device. The purpose of a clinical trial is to find new and improved methods of treating diseases and medical conditions.
Who can participate in a clinical trial? All clinical trials have set criteria specifying who is eligible to participate. The criteria used are based on such factors as age, gender, type and stage of disease, previous treatment history and other medical conditions. The criteria help to ensure that researchers will be able to best answer the questions being asked in the study.
Why participate in a clinical trial?
By participating in a clinical trial, you are taking a more active role in your own health care and gaining access to new research treatments before they are widely available. You are also helping future generations by contributing to medical research.
What are the benefits for trial participants? By participating in a research study, you may benefit from more frequent follow-up visits with your physician and the additional care provided to study participants. You can also feel good knowing that the information learned from the study will benefit patient care in the future.
If I decide to participate, will my insurance be billed for this? No, your insurance will not be charged for any tests or procedures that are done solely for the purposes of a research study. Sometimes studies involve devices that are reimbursed by insurance companies. In those cases, they have received "approval" by Medicare and the Food and Drug Administration (FDA) to be eligible for reimbursement.
What if I change my mind later? Can I withdraw at any time? Yes, your participation is completely voluntary. You may withdraw your participation at any time. If needed, the investigator and research nurse will work with you to ensure that it is done in a safe manner.
If I elect not to participate, will I still get good care?
Yes. Your care will not be affected by your decision to participate or not to participate. You will receive excellent care regardless of your decision.
Does my doctor want me to do this? What does he think? Your doctor has reviewed this study and endorsed it. He is part of the investigative team and supports it as a valid and worthwhile endeavor. Your participation, however, is voluntary and it should be your decision whether or not to participate.
Will I get paid for this? No. In some instances research subjects are reimbursed for travel and parking expenses incurred as a result of required study visits, but generally there is no reimbursement for participation.
Will I know the results of this study? When? It depends. You may or may not ever know. If specific information is shared with us by the sponsor at the end of a study, we will pass it along to you. Many times the results of studies are published in medical journals or are reported in the media. You are always welcome to contact Sentara Cardiovascular Research Institute for information about clinical trial outcomes.
What should people consider before participating in a clinical trial? If you are thinking of taking part in a clinical trial, find out as much as you can about the study. Here are some important questions to ask:
What is the purpose of the clinical trial?
What kinds of tests and treatments does the trial involve and how are these tests conducted?
Why do researchers believe the experimental treatment being tested may be effective? Has it been tested before?
Who is sponsoring the study? Who has reviewed and approved it?
What are the possible risks, side effects and benefits of the study and how do they compare with my current treatment plan?
How might this trial affect my daily life?
How long will the trial last?
Will the trial require extra time on my part?
Will I have to be hospitalized? If so, for how long?
Who will pay for the experimental treatment?
Will I be reimbursed for other expenses?
What type of long-term follow-up care is part of this study?
How will I know that the experimental treatment is working?
Will results of the trials be provided to me?
Who will be in charge of my care?
If I decide/agree to withdraw from the trial, how will my care be affected? Will I need to change physicians?
May I talk with some patients already enrolled in the trial?
What are the risks of participating in a clinical trial? Here are some of the risks the National Institute of Health suggests you consider before joining a clinical trial:
New drugs or procedures under study are not always better -- and could be less effective -- than the standard care to which they are being compared.
New treatments may have side effects that doctors do not anticipate.
Participants in randomized trials will not be able to choose the approach they receive.
Health insurance and managed care providers may not cover all patient care costs involved with participation in a study. These costs are usually paid for by the sponsor and will be described in the study consent form you will read and sign.
Participants may be required to make more visits and undergo more procedures than they would if they were not in the trial.
What about confidentiality? All protected health information will be maintained in strict confidence as required by law. However, your protected health information may be disclosed if required by law. In the consent form, it will be disclosed to you what information is to be shared, with whom it will be shared and for what purpose. Information learned from research may be used in reports, presentation and publications. None of these will personally identify you.
Will I have to sign anything? Yes, if you agree to participate in a clinical trial you will have to sign an informed consent form. Informed consent is a process by which people learn the important facts about a clinical trial to help them decide whether to participate. This information includes details about what is involved, such as the purpose of the study, the tests and other procedures used in the study, and the possible risks and benefits. In addition to talking with the doctor or research nurse, people receive a written consent form explaining the study.
People who agree to take part in the study are asked to sign the informed consent form. However, signing the form does not mean people must stay in the study. People can leave the study at any time—either before the study starts or at any time during the study or the follow-up period. The informed consent process continues throughout the study. If new benefits, risks, or side effects are discovered during the study, the researchers must inform the participants. They may be asked to sign new consent forms if they want to stay in the study. You will be given a copy of the signed consent form.