- Informed consent: The informed consent document is created to ensure that each patient completely understands the study and makes an informed decision about their participation. The consent form contains information about the risks and benefits, the purpose of the study, duration, and procedures.
If you are interested in a study, you will be given a consent form to review. It is encouraged that patients take time to read this document fully and ask any questions that they have during their review. Once a qualified participant reviews the consent and decides that they would like to enroll in a particular clinical trial, they will be brought to the site.
Your first visit will begin by reviewing the informed consent form with the research staff. If you decide to participate, the informed consent document will be signed at this time. If a patient is cognitively unable to sign for themselves, they can verbally agree to the study and their legally authorized representative can sign the consent form on their behalf. The informed consent is not a contract; you are free to withdraw from the study at any time. The informed consent is an ongoing process and the research staff should ensure that you want to continue to participate throughout the study.
- Confidentiality: Confidentiality is important to patients and researchers during clinical trials. When you participate in a clinical trial you are given a random number so that your name is not associated with the data you contribute throughout the study. As with a regular doctor, researchers are required to be HIPAA compliant.
- Drug vs placebo: Most phase 2 and 3 studies are randomized. This means that each patient is randomly assigned to get one of the dosages of the investigational product or placebo. Generally, neither you nor your doctor will know what you were randomized to during the trial. Randomization creates groups that are as alike as possible. This is important in clinical trials because it allows the data from the control group to be compared to the group on the study medication. This comparison provides the best way to prove the effectiveness of a new medication.
- Visits: Each study differs in how many visits there are, the lengths of the visits, and what is done at each visit. During the study, you will be required to come to the research site and perform the procedures outlined in the informed consent document; this generally includes safety measure, like blood draws and vitals, and questionnaires to help determine if the investigational product is working.
- Communication: While you are participating in a clinical trial, it is important that you are open and communicate with your research coordinator. The research coordinator needs to be made aware of any changes to your health; even if you do not think it is related to the study medication. It is also important that you communicate any medication changes that you and your doctors would like to make while you are on investigational product. This is for your safety to ensure that none of your medications interact.