Clinical trials are used to improve current therapies and develop new treatments for both common and rare diseases. Participating in a clinical trial can be a way to help develop those treatments which may help you and other people down the road. David Hill, MD, the director of clinical research at Waterbury Pulmonary Associates and an American Lung Association Board Member, believes that clinical trials are essential to advancing our understanding. “They are how we advance scientific research and help develop potentially more effective and less harmful therapies for diseases,” he explained. He helped answer some of our biggest questions about who should consider a clinical trial and how they work.

Dr. David Hill

Who should consider participating in a clinical trial?

“I think there is some altruism and some personal gain when participating in a clinical trial,” Dr. Hill said. “It can be for anyone; it just depends specifically on the question that researchers are trying to answer and the population they are looking to measure changes for over time.” One such study, the Lung Health Cohort is currently being run by the American Lung Association’s ACRC network. It is in the process of recruiting 4,000 young, healthy adults to paint a clearer picture of lung health and the factors involved in predicting and preventing lung disease.

If you have a severe disease with a poor prognosis, a clinical trial may be your best option to try something that may work better than current care. A clinical trial may be a good option if you are interested in a new therapy or medical device or a more favorable reported outcome. “There are benefits for people in all disease states, but those with a severe disease are more likely to look for a clinical trial as something to try,” Dr. Hill said.

How do clinical trials work? What should someone expect?

Before anyone can be deemed a candidate for a clinical trial, they will need to have an initial visit where records would be reviewed, and screenings would be done to determine their eligibility. Informed consent from the participant would be obtained before any study procedure or testing is performed. This means that the clinical trial will be explained in full, along with potential benefits and risks and from there the patient will decide whether to participate. If they give consent, history, physical examination and testing is done to establish a baseline. After that, each clinical trial varies depending on what disease is being treated and the type of treatment. Once treatment is completed, post-trial testing will be done, including follow-up appointments.

How safe are clinical trials?

Clinical trials are incredibly regulated, which means, from a safety standpoint, there are multiple people looking to make sure that the design is safe. This includes ensuring that a patient has a thorough understanding of all consent forms, especially all the risks and benefits. Institutional review boards independently monitor and must approve trials before they are allowed to proceed. There is also federal oversight to make sure that the trials are being conducted in the proper fashion. “They are experimental so there can be some risks depending on the treatment and the disease and those should be spelled out for patients ahead of time. And any participant can decide to stop participating at any time,” he explained.

When developing a new medication, treatment or device, there are preclinical studies that happen in the laboratory and then a number of phases in human subjects. To learn more, visit our vaccine page.

How much do they cost?

A clinical trial should never cost you money. They require you to invest time, as you may have to go somewhere for multiple visits and tests. Sometimes they will offer some small reimbursement to make up for this time or cover the cost of standard care treatment to make sure that everyone, even those in the control group, are getting the same care.

Clinical trials are vital to safely make new advancements in medicine. Find out if one is right for you.

Content created in partnership with Horizon Therapeutics and Sanofi Regeneron.

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