Clinical trials: How you can make a difference
Since the beginning of the pandemic, the term “clinical trials” has become common as researchers quickly investigate ways to treat and protect Americans against coronavirus. But what does that process look like and how can you help? Prisma Health Strategic Research Project Director Rebecca Atkinson explained.
What are clinical trials?
According to the Food and Drug Administration (FDA), clinical trials are a specific type of clinical research. Clinical trials are phased studies that involve drugs or devices which are approved by the FDA. Clinical research, however, is a broader context of investigation which includes research in treatment, prevention, screening, diagnostic, and quality of life. Researchers around the world are conducting clinical trials and clinical research to understand COVID-19.
Why are clinical trials important?
Clinical research, including clinical trials, is an important investigative process for physicians to study and find new ways to prevent, detect and treat disease. It has long been the accepted process to advance medical science and discover better treatments and practice for the future.
Patients who are affected by disease volunteer for research to access innovative treatments. The process requires participants who are healthy to serve as controls as well as participants who have an illness that we are seeking to cure. Both types are necessary to find and evaluate medications and treatments to prevent, manage and cure disease.
What is the typical process of a clinical trial?
Clinical trials are conducted in a series of steps called “phases.” Each phase has a different purpose and helps researchers answer different questions on safety, effectiveness and optimal use.
In an FDA regulated clinical trial, there are four phases:
- Phase 1 typically has a small population (fewer than 100 participants) and the purpose is to evaluate how safe the drug is and what dose of the drug can be tolerated.
- Phase 2 involves more participants and helps determine how effective the drug is and how common and serious side effects may be.
- Phase 3 involves even more participants and will typically last for a longer period. In this phase participants are followed longer to help determine what the longer-term effects of the drug may be. During phase 3, the FDA will decide if the drug can be marketed to the public.
- Finally, in phase 4 the goal is to expand the drug to other populations or diseases by increasing how the drug can be marketed. The focus here is usually to gain more safety data.
As the clinical trial progresses, the group of participants may be expanded to include different age ranges, broader representation of racial/ethnic groups and children.
Clinical trial participation is voluntary, but not all patients will be eligible for clinical trials. Before someone participates in a trial the study team will explain the risks and benefits of participating. Volunteers will have a chance to ask questions and understand the study.
Before starting a clinical trial, you will review and sign a consent. An informed consent provides the necessary information to help patient volunteers make the decision to participate in the study or not.
Consent forms outline the following:
- Details of the study including the purpose or why the study is being done
- How long it will last (which could be several years)
- The tests or procedures the volunteer will complete
- The risks and potential benefits
- What known side effects may occur
Only volunteers who fully understand this information should agree to enroll in the clinical trial.
What should you consider before participating in a clinical trial?
Volunteers must decide what is in their best interest before agreeing to enroll in a clinical trial. For healthy volunteers and for volunteers who have a 50/50 chance of getting the experimental drug, the reason for joining may not be a direct benefit for their own health. Rather, it may be for others who will benefit from new drugs and treatments.
Participants should also verify with their insurance provider to determine if there are any concerns related to their participation.
What should you do if you’re interested in participating in a clinical trial?
To find clinical trials and clinical research, the best place to start is with your own provider. You can also review your health system’s website or national resources, such as ClinicalTrials.gov, Research Match, or WCG CenterWatch. Healthy volunteers are needed so we can compare how effective treatments are for individuals who have an illness and those who do not. All types of research volunteers are needed for the research process and to advance medicine.
“Medical science has been at the forefront of combating COVID-19 this year. And thanks to thousands of participants, investigators know more about coronavirus and how to best treat it,” said Atkinson.
To learn more about clinical trials and the clinical research process, visit the NIH’s website Clinical Research Trials and You.
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