Frequently Asked Questions
A clinical trial is one of the ways medical professionals and drug companies go about evaluating the potential safety and effectiveness of new and/or already approved drugs for potential human use. By the very fact that it is designated a “clinical” trial means that it involves people. The design of the trial, its goals and the methods to be used must be carefully spelled out in a written document called a protocol. Before a clinical trial can begin enrolling people into the study, it must be approved by an independent body known as an Institutional Review Board whose responsibility is to insure that the study is conducted properly, ethically and insures at all times the safety of the people participating in the trial.
Clinical trials provide vital information about what happens when the drugs under study are actually taken by people. There are two main benefits to your participation in a clinical trial. The first is that you, personally, may obtain benefit from taking the drug under evaluation. The second is that others may ultimately derive benefit from the information obtained from the clinical trial that you participated in.
An “experimental medication” is a drug that has not yet been approved by the Food and Drug Administration (FDA) for doctors to prescribe to their patients.
Yes. You will be seen by a study physician at every visit.
By law, before any study-related assessments and procedures can be conducted, and before you can be permitted to take any study-related medication, you must be advised and understand up front a) that you know and are agreeing to participate in the study, b) what your participation in the study will entail, and c) what your rights as a study participant are. You will be given a written document known as an “Informed Consent Form” for you to review and sign. One copy will be kept on file at the site and one will be given to you for your files.
Participation in a clinical study is kept strictly confidential. Once enrolled in the study you will be assigned a special number and that number will be used going forward to identify you as a participant in the study. Your name will no longer be used. Any and all information obtained while you are participating in the study will also be kept strictly confidential and may only be shared where permitted by law or upon your prior authorization.
You are free to withdraw from participation in the study at any time without any negative consequences to you.
Participation in the study is free of charge. Neither you or your insurance company will be billed for the study drug or any study-related procedures.