What Is a Clinical Trial and Why You Should Sign Up for One
Clinical trials (also known as “clinical studies” or “interventional studies”) are research studies where people volunteer to receive new types of medical treatments so that researchers can evaluate the safety and effectiveness of these treatments in humans.
The treatments tested can include new drugs or combinations of drugs, new vaccines, new medical devices, new ways of doing surgery, new radiological procedures, or new ways to use an existing treatment. They can also study diet or behavioral changes, or ways to improve quality of life for people experiencing chronic health problems.
People of all ages and backgrounds, whether they are healthy or have a medical condition, are eligible to participate in clinical trials.
Why should I join a clinical trial?
Clinical trials are safe, necessary, and at the heart of all medical advances. Many effective treatments used today, such as chemotherapy, cholesterol-lowering drugs, vaccines, and cognitive-behavioral therapy, would not exist without volunteer participants.
However, there is a huge disparity in who signs up to volunteer. Clinical trials have historically relied on white male study participants, creating gaps in our understanding of effective treatments across populations.
Ethnic minorities, such as Asians, continue to be underrepresented in clinical trials. A 2021 study found that only about 5% of American adults have ever participated in a clinical trial, and that minorities, young adults, and people with a lower education status were less likely to volunteer.
Since people may experience the same disease differently, clinical trials need to recruit volunteers with a variety of lived experiences, including race and ethnicity, age, sex, and sexual orientation. Volunteering for a clinical trial can help ensure safe and effective treatments for members of one’s community in the future.
Some trials offer payment and some cover travel expenses. Certain people may volunteer for clinical trials when they’ve already received standard treatments without success, or are unable to withstand certain side effects of existing treatments. Clinical trials are safe, necessary, and at the heart of all medical advances. Many effective treatments used today, such as chemotherapy, cholesterol-lowering drugs, vaccines, and cognitive-behavioral therapy, would not exist without volunteer participants.
However, there is a huge disparity in who signs up to volunteer. Clinical trials have historically relied on white male study participants, creating gaps in our understanding of effective treatments across populations.
Ethnic minorities, such as Asians, continue to be underrepresented in clinical trials. A 2021 study found that only about 5% of American adults have ever participated in a clinical trial, and that minorities, young adults, and people with a lower education status were less likely to volunteer.
Since people may experience the same disease differently, clinical trials need to recruit volunteers with a variety of lived experiences, including race and ethnicity, age, sex, and sexual orientation. Volunteering for a clinical trial can help ensure safe and effective treatments for members of one’s community in the future.
Some trials offer payment and some cover travel expenses. Certain people may volunteer for clinical trials when they’ve already received standard treatments without success, or are unable to withstand certain side effects of existing treatments.
Are clinical trials safe?
Yes, though each trial comes with its own risks. The U.S. Food and Drug Administration (FDA) requires that researchers give their prospective participants complete and accurate information about how the trial will be carried out, including information about potential risks and benefits.
Volunteers then sign an informed consent document acknowledging they were given this information before agreeing to take part in a trial. They can choose to leave the trial at any time.
Clinical trials must pass through three phases of testing before becoming eligible for FDA approval. These trials are subject to regulations and guidelines under the FDA’s Bioresearch Monitoring (BIMO) program, which was established to protect the rights, safety, and welfare of participants and ensure they do not face unnecessary risk.
The FDA assigns most trials an Institutional Review Board (IRB) made up of doctors, researchers, and community members who review and approve the research before it can take place. Some studies are also assigned a Data Monitoring Committee (DMC) made up of a group of independent scientists who track the trial’s safety and integrity.
Who funds clinical trials?
Clinical trials can be funded by government agencies like the National Institutes of Health and the U.S. Department of Defense. They can also be sponsored by private investors, charities, universities, research institutions, and pharmaceutical companies.
Each trial is led by a principal investigator, often a medical doctor, and has a research team made up of other doctors, nurses, social workers, and health care professionals. The sponsor determines the locations of the trials, usually conducted at medical centers, universities, clinics, hospitals, or other research sites.
Where can I find and join a clinical trial?
You can search for clinical trials you may qualify for on ClinicalTrials.gov, a database of privately and publicly funded clinical studies conducted around the world.
As of May 2024, this database lists nearly 500,000 clinical trials with locations across the U.S. and in 223 other countries. 67,000 of these studies are currently recruiting volunteers.
To find a COVID-19 vaccine or booster near you, go to https://www.vaccines.gov/.
To volunteer for a clinical trial, go to https://www.researchmatch.org/.
