Odds are that if you’re interested in a clinical trial for a condition or disease you can find one. Clinical trials, or research studies, test medical questions in people as they live their daily lives. There is a wide range of types of studies, classified by their risk level. Some studies look into your experiences having or being treated for an illness, and doctors may ask you to fill out questionnaires. Other studies may be testing a new drug or intervention for the first time, which involve more rigorous oversight by your doctors. Studies may also be an option at a critical life phase, such as using a new device as a life-saving measure, requiring more stringent oversight still.
With an enormous amount of information to sift through, consider these points when deciding to join a clinical trial.
Clinical trials are not for everyone, and they can be invasive and require additional visits or procedures that are being done for research purposes only. Yet altruism remains the #1 reason for joining a clinical trial, as the idea of helping the greater good and contributing to a growing body of scientific knowledge is appealing. Studies are also an option when treatment choices for a disease are limited and access to the newest therapies are offered only via trials.
Some people may have never considered joining a study until their life is directly impacted by a disease, or they want to learn more about a condition. Regardless of the how involved the study is, anyone who enrolls in a clinical trial will go through the same process to make sure you understand what you’re signing up for.
The first step in the process if called informed consent. You and your doctor (or other qualified individual) will review the study in detail and discuss any questions together. A consent form is typically a lengthy document that uses lay language to explain what will happen if you enroll, the potential risks (including who may have access to your protected health information), and address the fact that you may not benefit from the study in any way.
A study should be presented in a neutral manner with all relevant facts included. Most importantly, it will be clearly stated that, even after you agree to participate, you may withdraw your consent at any time without any negative impact on your care. Research is entirely voluntary, and you have every right to change your mind if you no longer want to participate.
When studies are integrated into your overall medical care, there are some procedures that you may have done anyway (such as blood work), and the results can be used for the trial to limit repeat tests. Other times you’ll undergo extra tests or an increased number of them (such as extra MRI scans) as part of the study. These will be described in the consent form in the context of paying for your healthcare. If tests are “standard of care,” you or your insurance will be responsible for paying for them, as you typically would. However, anything that is strictly research-related will be paid for by the study itself, and you will incur no costs.
The potential benefits of being in a study will also be described in the consent form, although the language should never be coercive. The wording can be very blunt, saying that you may not benefit at all from participating or may in fact be harmed. However, study participants were some of the first to benefit from approved, now ubiquitous treatments when they were tested in clinical trials. Other benefits include payment, usually in the form of gift cards or vouchers for food or parking, aimed to align with your time commitment for study visits. However, many studies do not offer any payment.
You don’t necessarily need to be experiencing any health problems to join studies. Healthy volunteers, known as controls, can seek out studies that use a comparator group to test the question being asked, and these studies usually compensate the participants.
They key point is that you should feel fully informed and willing to participate when you sign the consent form. You may un-enroll at any time and may ask as many questions as you’d like. Clinical trials are learning opportunities for both patient and doctor, a collaboration that helps guide scientific innovation and answer pressing medical questions in real time.