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How you can become part of a clinical study

Posted February 5

The National Institute on Aging is seeking people to join a national registry that will help researchers study Alzheimer's disease. It's one of thousands of opportunities for people to participate in studies that may improve public health. (Deseret Photo)

When clinical trials make the news, it's usually because of a breakthrough in a medical treatment, or the promise of one, as in Zika vaccine trials that are underway. Sometimes, tragically, it's because people died during a study.

But thousands of research studies take place successfully with no publicity, and many that are scheduled have to be delayed or canceled because not enough people volunteer. Minority participation is a particular concern; in two recent cancer trials, just 1 percent and 3 percent of participants were African-American, The New York Times reported.

In January, the Food and Drug Administration urged more Americans to sign up for research studies, saying there's also a need for more women and older adults to participate.

"Overall, few people actually sign up for and participate in trials, and those who do participate don’t always represent the U.S. population. Participation is especially low for certain populations, including adults age 75 or older and people from certain racial and ethnic groups," the FDA said in a statement.

At any given time, there are hundreds of studies and trials seeking participants across the U.S., and they need both sick and healthy people. While many are specific to a disease or condition — such as trials on new medicines — others are general studies that survey a large population about their health habits, or have participants eat a certain kind of diet to see if their health markers improve. Often, participants are paid.

Among the most famous is the renowned Framingham Heart Study in Massachusetts, which has been ongoing since 1948 and today includes grandchildren of the original 5,000 participants who were enrolled.

Now researchers working on cures for dementia are hoping an Alzheimer's Prevention Registry will help make an equally significant impact. The agency is encouraging healthy adults over the age of 18 to register for the program, coordinated by Banner Health's Alzheimer's Institute. People who register will be notified of nearby clinical studies for which they might be eligible.

In a video on the website, Jessica Langbaum, the registry director and principal researcher, recounts her grandfather's battle with Alzheimer's disease, and explains why the database is important. For studies to go forward, researchers often have to screen 10 to 15 times the number of people they need to get participants who meet the criteria. About 80 percent of studies are delayed because of insufficient volunteers.

"For instance, we might have to screen 30,000 people to find a few hundred to a thousand people to fill a research study. If we can fill those studies faster, we can get to answers faster and hopefully get a cure or a preventative treatment faster," Langbaum said.

Types of studies

According to the National Institutes of Health, there are two kinds of research studies that use human volunteers: clinical trials and observational studies.

In a clinical trial, participants follow a specific plan created by researchers; they may be given drugs, vaccines or medical devices, undergo procedures, or make changes in behavior, such as diet and sleep.

In observational trials, the researchers analyze health outcomes of a group that may or may not take drugs or make changes in their lifestyles. "For example, investigators may observe a group of older adults to learn more about the effects of different lifestyles on cardiac health," the NIH's clinical-trial website says.

Data collection can take place at hospitals, universities, doctor's offices and community clinics, according to the NIH. The length of the study can vary from days to decades. Participants can drop out at any time, and their rights are detailed in an "informed consent" document that they sign.

Studies can be sponsored by the government, medical facilities, drugmakers or even food producers. But in every study, the NIH stresses, participants should take the time to understand the potential benefits and risks, which is why the informed-consent document is required.

In the past, some unethical researchers were not so forthcoming, as in the infamous Tuskegee syphilis study in Alabama, in which the government withheld treatment from African-American men in order to study the progress of the disease. A class-action lawsuit was later filed on behalf of the men and their families, and the government paid more than $9 million to survivors more than 40 years after the study began.

Such abuses are now prevented by the requirement of informed consent, and by oversight committees called institutional review boards.

Risks and benefits

To join the Alzheimer's Prevention Registry, people have provide their name, age, city and email address; sharing information about family history with Alzheimer's is optional, as is filling out a more detailed questionnaire. The registry website promises that the data won't be shared without a participant's permission and that it is stored in a "highly secured environment" — a legitimate concern since Banner Health suffered a cyberattack last fall that affected more than 3 million people who used credit cards at the nonprofit's food-service facilities.

Of course, having personal information exposed is a slight risk compared to the concerns of those who enter clinical trials that test new drugs. Last year, five cancer patients died during a trial of a new therapy in a case that left the Food and Drug Administration under fire.

But many studies open to the public don't involve drugs. Some examine the effect of exercise on people; others test how certain foods or diets affect the body. Most offer payment to cover participants' time and travel, and some provide meals and occasionally even temporary lodging.

Studies that are currently enrolling include one at the University of California, Davis, which will examine whether almond consumption affects facial wrinkles; one at the Mayo Clinic in Rochester, Minnesota, on sleep restriction and cardiovascular health; one on consumption of olive oil for breast-cancer prevention in high risk women, at Houston Methodist Hospital in Texas; and one on high-intensity interval training in Murray, Utah.

(Regrettably, it's too late to enroll in the study that tests whether camel milk is a suitable substitution for those allergic to cow's milk. And it was in Israel, anyway.)

To search for a research study near you, go to the the website clinicaltrials.gov, where you can search by a condition, location or topic. You can even search for a type of food or beverage being studied, such as milk or orange juice.

Another way is to do an internet search for a university name and clinical trials; for example "University of Utah" and "clinical trials," or "Mayo Clinic" and "clinical trials." The National Institutes of Health also offers online information about clinical trials by condition.

Not everyone who applies is selected; there's a different set of criteria for every study. But if you are invited to participate, the NIH suggests a list of questions you should ask before accepting.

Among them: Who will pay for my participation? Will I be reimbursed for other expenses? What type of long-term follow-up care, if any, is offered? And will the results of the study be provided to me?

And the NIH also suggests you let your doctor know you are participating in a study, even though he or she won't likely be involved.

EMAIL: jgraham@deseretnews.com

TWITTER: @grahamtoday

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