Are you thinking about participating in a clinical trial? Here are 6 things you should know!
Clinical trials can be an intimidating and unexplored area for many people. Some may have been exposed to the basic principles of research methods in school, while others may not be familiar with research or clinical trials at all. Regardless of your experience with research, this article is for you! If you are considering participating in a clinical trial, here are 6 things you should know to make the best decision for yourself!
Are clinical trials safe?
Safety is paramount, not just in medicine, but especially in research. Before clinical trials can even begin enrolling patients, there are many requirements, reviews, and approvals that must occur. In fact, oversight occurs at every single stage of research from the very beginning of the study through to approval of the medication or device and continues throughout the entire study duration. Government oversight, study sponsors, ethic committees known as Institutional Review Boards, medical staff, and research personnel are all watching closely throughout the clinical trial to ensure that participants are safe. Although there can be risks to clinical trials, these are always made known up front to participants, and stated clearly and understandably with plenty of opportunities for questions and conversation with the research personnel. Additionally, study protocols build in contingency plans to ensure that correct medical action is taken, and care is provided right away.
What happens to my personal information and study data?
Clinical trials and research must maintain confidentiality, as with any protected health information, by law. The informed consent process is where the research staff must tell you all about the clinical trial, including potential benefits and risks, and this includes what happens to your personal information and study data. It depends on the study, but protections are in place through laws such as GINA (Genetic Information Nondiscrimination Act) which protects participants from discrimination in health insurance and employment based on their genetic information. However, depending on the study, it may be possible for your data to be used for future research purposes, and so the informed consent process is the perfect time to ask questions and understand exactly what can and cannot be done with your information during and after the study.
How do I find a clinical trial?
Clinical trials must be listed on clinical trials.gov, so this can be a great way to find a full list of studies ongoing for sarcoidosis. The Foundation for Sarcoidosis Research website also has a featured page for sarcoidosis-specific studies containing links to see if you might qualify, and to put you in touch with the study teams in charge of the clinical trial. New clinical trials are constantly emerging, and there are often many opportunities to become involved in research, so check back often for new opportunities! Learn more here.
How do I know if I can join a clinical trial?
Each clinical trial has different criteria, which will determine if you are eligible for the clinical trial. A great way to get started is reaching out to the study team through the clinical trial websites. Many clinical trials have dedicated websites with pre-qualification forms, which can be completed and reviewed by their teams. The study teams will then contact you to confirm your eligibility status and get you started. Because each study has different criteria, not every study may be right for you, but it can be helpful to share with others who may be eligible and to keep searching for studies you may be eligible for yourself!
How will I know what to do in the clinical trial?
Clinical trials can be complex. Some may have many required visits with the study team, and may include sample and data collection, while others may have few. Thankfully, the research study personnel for the clinical trial will check in with you when your visits are upcoming. Transparency is key to research, and research personnel will tell you ahead of time what procedures will be performed, and any forms that you will need to complete at the visit.
Why should I consider clinical trials? What is the point?
Clinical trials are crucial to our understanding of diseases. They help us to explore the nature of diseases, and to find answers to our questions about why they occur, how they manifest, what signs can help with detection, and if there are potential treatments that can be found. Without clinical trials, these questions become hard to answer, and may slow the rate of new methods of detection, management, and treatment of the disease. Clinical trials cannot be successful without collaboration between all parties involved, from the study drug or device provider to the research site, and especially, the study participant. With the knowledge gained from clinical trials, it can lead to better knowledge of prevention, detection, management, treatments, and potentially even a cure for diseases.
Clinical Trial Resources:
Uncovering the Future of Sarcoidosis Treatment and Clinical Trials Webinar
Transitioning Off Steroids and onto New and Investigational Treatments Webinar
The EFZO FIT™ Clinical Trial Making History for Sarcoidosis Patients Webinar
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Written by: Timothy Legenzoff, FSR Research Manager.