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How to Participate in a Clinical Trial

New policies and guidelines emerge to ensure that more people, especially those age 65 and older, are included in clinical trials.

All his life, Steve Sultanoff, 66, had high cholesterol, a problem that runs in his family. When he was younger and didn’t have great health insurance, he decided to participate in clinical trials to get better health care and help discover new medicine that would benefit him.

He was put on statins, but those gave him terrible muscle aches. It took 30 years of participating in some 10 to 15 clinical studies before Sultanoff hit pay dirt — an injectable medication that lowered his cholesterol with almost no side effects. “I couldn’t be happier,” says Sultanoff, who lives in Irvine, Calif.

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The health industry needs clinical trials to test new medications before they are brought to market, and clinical trials need participants — healthy people and those with chronic conditions. But Americans, especially those age 65 and older, often aren’t part of the very studies for new medications that could treat an aging population.

“Historically, aging adults are not in clinical trials, even when testing for diseases that disproportionately impact older adults,” says Lindsay Clarke, vice president of Health Education and Advocacy at the Alliance for Aging Research in Washington, D.C.

There are several reasons for this. Some studies impose arbitrary age limits for enrolled participants. Others may use criteria that disproportionately affect older people, such as excluding those with multiple health problems or physical or cognitive impairments, writes Barbara Radziszewska, health scientist administrator, Division of Geriatrics and Clinical Gerontology for the National Institute on Aging, on the institute’s website.

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As a result, the National Institutes of Health and the Food and Drug Administration have created new policies and guidelines to ensure that more people, especially those age 65 and older, are included in clinical trials.

Be Proactive

If you want to participate in a clinical trial, the first step is to ask your general doctor or specialist if they know of any that you could participate in. If the answer is no, it is easy to search and apply for such trials. All clinical trials nationwide—and there are typically thousands going on at one time across the country—are listed on the National Institutes of Health’s searchable database Clinicaltrials.gov.

The nonprofit Center for Information and Study on Clinical Research Participation uses information from Clinicaltrials.gov, but in easy-to-understand language. Submit a brief form on its website and the group’s staff might be able to help you find a clinical trial.

For trials that address a particular health condition, check out the website of a well-regarded organization for that condition. For example, the Michael J. Fox Foundation for Parkinson’s Research provides information about clinical studies for Parkinson’s, while the National Organization for Rare Disorders does the same for its constituency.

Review the Terms

Before starting any trial, you will be screened and, if accepted, given information about the trial and asked to sign that you understand the terms for participating. You should not sign on the spot, but take the paperwork home, read all the information and talk it over with a family member or friend.

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Experts say, among other things, it should be clear:

  • How long the trial will take (they can be as short as a day or last for years).
  • How often you’ll need to visit a doctor’s office or hospital.
  • What the potential side effects are.
  • If you can continue taking your regular medication.
  • If researchers will talk with your regular doctor.
  • If you will be paid for travel and other expenses, or a stipend (sometimes you are, sometimes you’re not).

For Genma Holmes, 52, from Hermitage, Tenn., taking part in clinical trials was a matter of health and principle. As an African American woman, she is well aware of the negative association clinical trials have for black people, who have been subjected in the past—without their consent or knowledge—to sterilization and syphilis studies with horrific results.

She is in the maintenance phase of a three-year clinical study for a medical procedure to treat hypertension. Holmes said the ongoing monitoring during the trial helped her change her lifestyle and lose weight; that plus the procedure means she is now completely off blood pressure medication. She also recruited about 20 people to participate in hers and other clinical studies.

Doing a clinical trial, she says, was about “self-preservation and how to move the conversation in this community—not just for people of color, but for everyone.”

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