What Is a Clinical Trial?
Between headlining health scares and ongoing healthcare debates, it’s easy to forget that, at heart, medicine is dedicated to improving peoples’ lives. Doctors, researchers and medical innovators are constantly looking for new medicines and treatments to help us live healthier, safer and longer. One way to accomplish those goals? Clinical trials.
“Clinical trials are an integral part of any learning healthcare system that’s trying to improve the long-term outcomes of patients,” says Tommy Mikkelsen, M.D., medical director of the precision medicine program and clinical trials at Henry Ford Health System. “They’re not experiments on people, but with people, in order to gather solid data. From that, we can make treatment recommendations going forward.”
“A clinical trial is a voluntary research study that’s being conducted in humans with the goal of answering questions about new medical treatments, devices or procedures,” adds Tiffany Pearce, director of clinical trials at Henry Ford Health System.
“They help us answer questions like, ‘Does a treatment work?’ ‘Does it have side effects?’ or ‘Does it work better than other treatments?’”
Below, Pearce answers some of the most frequently asked questions surrounding clinical trials and how to determine whether or not participating in one is right for you.
Q: How does a clinical trial typically work?
A: Every clinical trial is conducted according to a very rigid plan that outlines what types of patients can be included in the trial, which procedures will be done, what drugs and dosages will be given, and what results will be measured to determine the effectiveness of the trial. It also describes what type of information will be collected and the length of the study.
Q: How do patients get involved in clinical trials?
A: As a patient, the best place to start is to talk with your care team about your interest in clinical trials. They’re the best ones to guide you through your treatment options and outline which clinical trials you might viably consider. Most of the time, clinical trials have strict requirements for the groups of people they wish to study. If you want to participate, you’ll be screened to see if you match the requirements (age, gender, family history, stage of disease, etc.) and then you’ll be fully informed of trial’s details. Once provide your consent, you’ll be enrolled.
Q: Why do people opt in/out of clinical trials?
A: When considering a clinical trial, patients need to consider the risks and benefits. Some patients opt into trials with the hope of improving or advancing medical care. Patients also enroll because they feel the trial offers the best or more effective treatment for their illness than what is currently available. Patients may also choose a trial because previous therapy for their condition wasn’t effective, or maybe there’s no treatment available for their health problem.
Q: What are the risks and benefits of enrolling in a clinical trial?
A: There can be a lot of unknowns with a clinical trial. You may experience unique side effects, the trial may not improve your health condition or it may have no effect compared to standard treatment. Some trials can also demand more of your time than a standard treatment plan.
Alternatively, a clinical trial gives you access to new treatments and technologies that may not be available any other way or be available to the general public for years. Also, clinical trial participants are often closely monitored, which means you may receive more care or advice during the trial.
Related Topic: 5 Reasons to Get a Second Opinion for Cancer Treatment
Q: What can you expect during a trial?
A: Every trial is different, but if certain actions or procedures are required of you, they will be outlined in your consent forms.
Q: Do I have to pay out of pocket costs to participate in a clinical trial?
Most of the time, a patient does not have to pay to participate in a clinical trial (nor will they be paid for their participation). That said, there are two types of costs associated with a clinical trial: 1) Routine patient care costs, such as doctor visits, hospital stays and lab tests. 2) Research costs such as the cost of the study drug or tests performed for research purposes. Insurance companies are not required to cover research costs, though they are often covered by a trial’s sponsor.
Q: What are the different phases of a clinical trial?
A: There are four phases to a clinical trial. Each one indicates where a new drug or treatment is in the research and approval process.
Phase I trials test an experimental treatment on a small group (usually fewer than 50) to determine its safety, side effects and proper dosage.
Phase II trials involve more people and tend to focus more on the effectiveness of a new medicine or treatment (i.e. is this really working or not?)
Phase III trials expand treatments further to include larger (and more diverse) populations. At this point, a new drug or treatment is usually approved by an organization like the FDA.
Phase IV trials are also known as the post-marketing surveillance stage and monitor the long-term effects of the medication or treatment in question.
Q: How do you know if a clinical trial is safe?
A: Every clinical trial is approved and monitored by the Institutional Review Board (IRB), which is designed to ensure patient safety and protect the rights and privacy of human subjects during a research study.
Participating in a clinical trial can be an exciting experience. After all, you’re helping to advance the field of medicine and help medical professionals learn how to help others in the future. Without eager participants (and curious researchers), the medicines and technologies we use today might never have left the research lab.
To speak with a representative from the Henry Ford Clinical Trials office, call (313) 916-1784.
Tiffany Pearce is the director of clinical trials at Henry Ford Health System.
Dr. Tommy Mikkelsen is a neurologist and medical director of the precision medicine program and clinical trials at Henry Ford Health System specializing in neuro-oncology, brain tumors and clinical trials.