Why You Should Consider a Clinical Trial

Often clinical trials just require a little more time and paperwork than your normal treatment. novak elcic/Shutterstock

I recently had a routine medical procedure and was asked to take part in a clinical trial. I asked a slew of questions and — other than taking a little more time and requiring a bit more paperwork — I couldn't see a downside. So, I said yes. When I went in for my appointment, I was asked if I'd do a follow-up questionnaire about what prompted me to agree to do the trial. The researchers were having trouble convincing people to take part and wanted to know what they could say or do to make people more interested.

From lack of information to fear of the unknown, there are many reasons that people don't take part in clinical research. In fact, a post in the Imperial Blog, which targets science professionals, cites 25 reasons people don't enroll in clinical trials. They range from worry about side effects to concern over costs. In some cases, people (and their doctors) just aren't aware the clinical trials exist.

Here's a look at clinical trial basics and why you may want to take part.

What are clinical studies?

A clinical study involves using human participants to help advance medical research and knowledge. There are two types of clinical studies: clinical trials (sometimes referred to as interventional studies) and observational studies, according to ClinicalTrials.gov. Although there's a difference, sometimes they are all referred to as clinical trials.

People who participate in clinical trials receive a specific drug, device, procedure or are asked to change a behavior (such as diet). These strategies or treatments are part of a research plan created by investigators. They might compare a new approach to one that's already being used, or to a placebo, or to no treatment at all. Researchers don't know if the new treatment will be helpful, harmful or no different than what's currently being used. The goal is to see if a new test or treatment works and if it's safe. For example, a participant might receive a new medication to see how it controls blood pressure versus a placebo, other medication or no medication.

In observational studies, participants aren't given specific treatments or procedures by researchers. Instead, their normal health outcomes are observed and recorded and may include treatment that is part of their routine medical care. For example, researchers might follow a group of older adults to observe how various lifestyle choices can impact heart health.

Here's a simple look at how clinical studies work:

Pros and cons of participating

Taking part in a clinical trial might give you access to beneficial new drugs or other treatments, sometimes long before they are generally available. During the trial, your health is monitored closely by health professionals.

In my case, I was chosen to take part in a 3-D mammogram versus the standard procedure. Although it's not new, it's not something I normally would have opted to have because the higher cost isn't covered by insurance. In this case, the difference will be paid by the study and I had access to a higher-quality procedure. Screeners saw something questionable that they might not have seen with the normal scan, so the trial gave me access to better screening tools.

There's also the much bigger picture. The information that investigators learn from clinical trials may one day help other people and improve health care. By taking part, there's the undeniably good feeling that you're helping humankind by advancing medical research.

On the negative side, there's a chance you will be given a drug or procedure that has side effects or doesn't work. Or even if it works for some people in the trial, it may not work for you. The trial may require more time and medical attention — doctor visits, procedures, phone calls, paperwork — than your normal care. In some cases, health insurance won't cover costs associated with clinical trials.

I took part in a clinical trial several years ago for migraine medication. I was hesitant because I worried that I would get the placebo and would have to live with my headaches with no relief. I believe there was a plan in place that I could turn to my old medication after a certain time period if my headaches persisted while on the trial drug. Fortunately, I received real medication and it worked. But I did have to make several extra trips across town and keep very detailed reports of my headache and medication.

How to get involved

clinical trial chart
People take part in clinical trials after the discovery phase. If treatments are successful, then they become available to patients. Marimaria/Shutterstock

Oftentimes your doctor will tell you about a clinical trial if you have a condition that she knows is being studied. But the best place to search is ClinicalTrials.gov, the database of privately and publicly funded trials around the world. Provided by the U.S. National Library of Medicine, the database offers more than 279,000 studies in every state, as well as more than 200 countries. Before you decide to take part in a study, talk to your doctor to make sure you're a good candidate.

In addition, make sure all your questions are answered. The investigators running the trial will explain its purpose, what will happen, any possible risks and benefits, and information about how the information will be shared. You will be asked to sign an informed consent document, which includes all these details. You can withdraw from the study at any time.

If you're still iffy about becoming a guinea pig for medicine, consider that nearly every drug, procedure and treatment we have today is because of people who were willing to volunteer to try them out.

"Only through clinical research can we gain insights and answers about the safety and effectiveness of treatments and procedures. Groundbreaking scientific advances in the present and the past were possible only because of participation of volunteers, both healthy and those with an illness, in clinical research. Clinical research requires complex and rigorous testing in collaboration with communities that are affected by the disease. As research opens new doors to finding ways to diagnose, prevent, treat, or cure disease and disability, clinical trial participation is essential to help us find the answers."

Sign me up.