2024 Autoimmune Community Summit Session Recap
Have you considered joining a clinical trial? In the Autoimmune Community Summit session What Autoimmune Patients Should Know About Clinical Trials, Shalome Sine Research Services specialist at CISCRP, covers the components of a clinical trial and what you should know before joining one.
A clinical trial is a study used to answer a specific health question like if a new treatment works.1
There are four phases to a clinical trial:
Small number of participants to test safety and dosage
Larger participant pool, continued safety and dosage testing to prove efficacy
How the treatment works, does it improve a medical condition
Real world experience monitoring the treatment after it has been approved
There are multiple members of a clinical trial team:
Principal Investigator or PI - organize and lead the trial and set the protocol
Clinical Research Coordinator - assists the PI and handles the day-to-day activities
Volunteer Protectors - review the study before it starts and make sure they are following the rules
Volunteers/Participants - those is participate in the study to test a treatment protocol
Volunteer protectors are super important. These organizations are super important and include groups like IRBs and the FDA. Institutional Review Boards or IRBs review, monitor and approve clinical trials to make sure they are ethical and fair and do not cause patients harm. The U.S. Food and Drug Administration (FDA) reviews studies and ultimately determines if the treatments are approved for use for a particular disease.
Once the study is reviewed and approved by volunteer protectors, participants are solicited. When participants apply to be in a clinical trial, they go through an informed consent process. During this process, they ensure that all participants understand what the trial is, how long it is, what the risks and benefits are and that you have access to the materials in your primary language.
You have the right to understand the trial, to ask questions and get answers, and to quit at any time.
It is important to know that every study has benefits and risks. Benefits might be access to new treatments, access to providers and researchers who know your disease and sometimes there are even financial benefits like gift cards for participating. Of course there are also risks. You might not respond to the treatment or even get worse. You might be given a placebo or you might suffer financial loss due to the missed work or paying for child care.
Clinical trials are necessary to get new treatments in the hands of patients like you. If you are interested in participating in a clinical trial, make sure you fully understand the study and weigh the benefits and risks. Remember that you can quit the trial at any time. To learn more visit the CISCRP Education Center.
Recordings from the 2024 Autoimmune Community Summit are available on YouTube.
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