What Is a Clinical Trial and Why You Should Sign Up for One
Clinical trials (known as “interventional studies” or “clinical studies”) are research studies where human volunteers receive new types of medical treatments so that researchers can determine how well those treatments work.
The trials determine whether these treatments — which can be a new drug, diet, medical device, or procedure — are safe and effective in humans. Clinical trials may also compare an existing treatment to a new one.
As of February 2022, there are over 400,000 clinical trials in the United States and in 220 countries, with over 7,500 research studies for COVID-19. These research studies need volunteers. About 4,000 of these studies are recruiting volunteers to participate.
There continues to be a lack of diversity in clinical trials, especially in age and ethnicity. It is important that these studies have a diverse array of participants, to test how new medical treatments affect different groups of people. For example: A drug that is suitable for younger people may not be suitable for older people.
That is why it is important that Americans of all backgrounds, if they are able to, volunteer to participate in clinical trials.
Where do clinical trials operate?
Clinical trials are often funded by government agencies like the National Institutes of Health (NIH) and the U.S. Department of Defense (DOD). They are also funded by pharmaceutical companies, academic medical centers, voluntary groups, and also individuals — such as doctors, health care providers, and other individuals.
Every clinical trial is led by a principal investigator, usually a medical doctor. The trials will also have a research team that will include doctors, nurses, social workers, and scientists. The trial locations depend on who is running the trials but they’re often in medical and educational facilities such as hospitals, universities, and health clinics.
Clinical trials will also tell the public how long the trials are supposed to last, so participants can know before they choose to enroll.
Are clinical trials safe?
Yes. Clinical trials must be approved by the U.S. Food and Drug Administration (FDA) before they can begin.
Before the FDA can approve a clinical trial to begin, the researchers must test the treatment through laboratory and animal testing to see if the treatment works. If the treatment has good results, the FDA will allow the treatment to be tested in humans in a clinical trial setting.
For each research study, an institutional review board (IRB) first ensures the study is ethical, and that the participants’ rights and welfare are protected. The IRB is made up of doctors, researchers, and community members, who all ensure that the risks of participating in the study are minimized. Some studies also have a data monitoring committee known as the “data safety and monitoring board” (DSMB), the DSMB are a group of independent scientists who track the safety and integrity of the trial. This committee can recommend to the sponsor that a trial is harmful, ineffective, or unlikely to serve its purpose.
Participants are also protected through a process known as “informed consent,” which is documentation used to provide potential volunteers with information — that includes the risks, potential benefits, and alternatives to the study. Along with documentation, informed consent may include verbal instructions, additional recruitment materials, and question-and-answer sessions. All of this is reviewed and approved by the IRB before the study starts.
Why should I join?
Ethnic minorities, such as Asians, are often underrepresented in research studies. This is a problem as people of different ages and ethnicities may react differently to certain treatments.
By being a part of a COVID-19 research study or any other clinical trials, you will find better treatments for your family, your community, and generations to come. If you get sick because of the coronavirus and are interested in volunteering for a research study, you could get access to newer treatments for COVID-19.
Where can I find and join a clinical trial?
To find more information on clinical trials, you can go to clinicaltrials.gov to see what research study you qualify for, and if there are clinical trials close to you.
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/.
