Here's What You Should Know Before Joining a Clinical Trial

You probably know scientific research is behind almost everything in your doctor’s office or hospital, from diagnostic tests to medications and the diet changes your doctor recommended. However, most research is hard to read and may seem like it has nothing to do with you — it’s just for the experts. That’s not exactly true — without the participation of patients, no new medical discoveries would ever be made. Enter, the clinical trial.

Clinical trials and research test out new health interventions, which could include medications, therapy, treatment devices or diagnostic tests. According to statistics from the nonprofit Center for Information and Study on Clinical Research Participation (CISCRP), more than 2.3 million people participated in a clinical trial in 2015. But what is a clinical trial and how do you get involved?

To demystify how clinical trials work, we broke down the risks and benefits as well as where you can find studies to participate in. Here’s what you need to know.

What Are Clinical Trials?

Most new medical treatments go through a lengthy research process before they get to a patient. Initially, proposed treatment interventions are tested in a lab until scientists can prove a potential intervention could be effective and safe for people. Then, a medical intervention is ready to be tested with real patients in a series of clinical trials, first in a Phase I study that’s small and experimental, and if everything goes well, eventually in larger groups of patients.

Nikita Curry, MHA, supervisor of the Office of Patient Recruitment at the National Institutes of Health (NIH) Clinical Center, told The Mighty clinical trials play a critical role in bringing new interventions to patients. She said:

Clinical trials enable the discovery of new treatments, medications and therapies. Clinical trials provide a lens into diseases in a controlled environment. They take promising, exciting discoveries from the lab bench and computer — and after a very rigorous review process — apply the discoveries to people to further understand their safety and efficacy.

Clinical trials can be very expensive. According to a report from the Johns Hopkins Bloomberg School of Public Health, the average cost of a clinical trial required to get a new medication approved by the U.S. Food and Drug Administration (FDA) is $19 million. In total, it costs around $2 to $3 billion to develop and test a new drug from start to finish. Because clinical trials are so expensive, they may be funded by government agencies like the NIH, private foundations, universities, or drug companies and treatment manufacturers.

What You Should Know Before Joining a Clinical Trial

Each clinical trial has strict criteria when recruiting participants, which could include a specific condition and other detailed demographics, such as gender, age and ethnicity. If you qualify based on a study’s eligibility criteria, researchers or your doctor (if they’re working with the researchers) should clearly outline what participating in the clinical trial will entail.

According to Curry, as a participant, you can always have the right to ask questions and say no at any point during the trial. “We put patients care, their welfare, first and foremost,” Curry said, adding:

It’s also important to know there are many safeguards that protect the safety and rights of research participants and that govern how biomedical research is done. We also do our best to ensure our patients understand they are empowered. We want them to voice questions, express their wishes, communicate every step of the way with care providers. As I mentioned, participation is voluntary. Nothing happens without their consent.

NIH’s clinical trial website suggests several questions you may want to ask before you consent to participate in a clinical trial. For example, you’re entitled to know what treatment you’ll get as part of the study, whether or not you may get a placebo or inactive version of the treatment, what tests you have to take, whether you need to spend time in the hospital, if your expenses will be reimbursed, and how your current medical treatment could be impacted.

“It is important that you fully understand the study and what your involvement would mean,” said Curry. “You should know the length of the study, the number of visits required and medical procedures and medications included. Before deciding to participate, carefully weigh these risks against possible benefits.” 

What Are the Risks of Participating in a Clinical Trial?

The prospect of testing an experimental or new medication or treatment might seem scary. According to a CISCRP report, in 2017, 40% of potential clinical trial participants said they were most worried about potential side effects, while 33% said they were concerned about their overall health. Curry said prior to beginning a trial, researchers will be very clear about your risks. Plus, you can opt-out at any time.

“Specific risks associated with any research protocol are described in detail in the consent document, which you should be asked to sign before taking part in research,” Curry said. “In addition, the major risks of participating in a study will be explained by a member of the research team, who should answer your questions about the study.”

What Are the Benefits of Clinical Trials?

On the other hand, there are several benefits of joining a clinical trial. It may provide access to new treatment options, especially if you have a complex chronic illness or rare disease. CISCRP found 44% of those who joined a clinical trial wanted better treatment options. Though many patients turn to clinical research only after exhausting all other treatment options, Curry said you can join a clinical trial at any time, even early on.

Depending on the design of the clinical trial you join or its eventual outcome, it’s also possible you won’t see much personal benefit from the new treatment or intervention after participating in a clinical trial. But participating in a new study can make a difference for others with your health condition. CISCRP found 49% of people took part in a clinical trial to help advance understanding and treatment for their condition and 39% to help others with the same illness.

Mighty contributor Gwendolyn R. Brown, who lives with pulmonary hypertension, explained why she participated in clinical research in an installment of “I’m Aware That I’m Rare.” She said:

I think [clinical trials] are important for patients, because even though the trial might not help me, it can help someone else. With the disease being as rare as it was, I put my name down for every trial. I am so amazed when I see all the medicine, all the treatments that are available now for people. It’s just astounded me. I end up crying because it’s just beautiful to see it all.

Where to Find Open Clinical Trials

To find open clinical trials you might be eligible for, start by asking your doctor. Often times researchers work with doctors, especially at medical universities or research hospitals, to find patients to participate in new research. Before joining any study, you’ll want to talk with your doctor first anyway.

You can also visit ClinicalTrials.gov or NIH Clinical Center Trials, databases that include more than 300,000 clinical trials taking place in the United States and 210 countries. You can filter the search results for just your condition (including chronic and mental illnesses) and location. The listing for each study tells you what interventions will be tested, who is sponsoring the study and details on what researchers are investigating. For clinical trials actively looking for participants, you’ll be able to see participant eligibility criteria as well as contact information if you’re interested in participating.

Whether a new treatment will help your condition or provide answers for others, Curry said clinical trial participants are key to how new medical advances are made, now and for future generations.

“The health and quality of life for millions has been improved because of advances resulting from the willingness of people to take part in clinical research,” Curry said. “I can’t emphasize enough that they are both our patients AND our partners in the quest for cures.”

Have you ever participated in a clinical trial? Let us know in the comments!

Have you participated in a clinical trial or study?

Article updated Feb. 11, 2020.