You will still get standard medical care and treatment for your cancer. You can leave at any time, for any reason.
#Free clinical trials maryland trial#
They also want to give you new information about the clinical trial or its treatment. The research staff wants to hear your questions and concerns any time you have them. You may want to keep this with your personal medical records. If you join the clinical trial, you will get a signed copy of your consent form. You might want to talk about this information with family members or friends. How the clinical trial staff protect your privacy and personal information How much it might cost you to be in the study How many doctor visits and medical tests you will need What you need to do if you want to join the clinical trial. These might be different from the possible risks and benefits of the standard treatment. The possible risks and benefits of the clinical trial's treatment. This includes how it is different from the standard treatment and why doctors are studying it. The treatment given in the clinical trial. This includes your choices if you decide not to join the clinical trial. They will talk with you about:Īll your treatment options. Your doctor, the research staff, or both will talk with you about the informed consent form and answer questions. This is called the informed consent form. They will give you printed information about what will happen in the clinical trial. The clinical trial's research staff can help you understand a clinical trial before you decide to join it. Who can help me understand a clinical trial before I join? Site visits may also be done by the FDA or other organizations. A DSMB sometimes also visits the place where a clinical trial is happening, called a site visit. They can also report on whether they think a clinical trial should change, stop, or keep going. They also make sure the clinical trial is safe for volunteers and is giving doctors helpful information. A DSMB is made up of experts who review data and check on how the clinical trial is going. The National Institutes of Health also checks clinical trials.ĭata and Safety Monitoring Board (DSMB).
The Food and Drug Administration (FDA) makes rules for clinical trials that involve experimental drugs or medical devices. Department of Health and Human Services provides clarification and guidance on the clinical trial process, develops educational programs and materials, and provides advice on ethical and regulatory issues. When it has all the information it needs, it approves the clinical trial so doctors can start it. The IRB does most of its work before a clinical trial starts. An IRB must approve and supervise any clinical trial that involves people. It protects the rights and well-being of clinical trial volunteers. An IRB is a committee of experts that makes sure a clinical trial is designed correctly, safely, and fairly. Below are the 3 main groups that make rules for clinical trials in the United States: This keeps you and other volunteers as safe as possible in the clinical trial. Doctors and research staff must follow these rules exactly. Several groups of experts make the rules for clinical trials. Experts also supervise the doctors, research staff, and procedures in a specific clinical trial. So every clinical trial has to go through a strict review process.
Keeping volunteers safe is the main concern in clinical trials about cancer. Watch the Cancer.Net Video: Clinical Trials and Safety with Eric Singer, MD, MA, adapted from this content.
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