Should You Join a Research Study? 9 Tips for Volunteers in Clinical Trials

By enrolling in a research study, patients can advance clinical care. But they need to consider safety.

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Know how participating would alter your care. If you enroll in a trial, how will the treatment you get differ from the care you'd otherwise receive for the same health problem? That's a question that Kevin Weinfurt, a psychologist who's in charge of assessing trial volunteers' experiences at Duke University Medical Center, recommends asking before deciding whether to sign up. Researchers are required to give all patients at least standard-of-care treatment, whether or not they get an experimental treatment as well. But while some trials give patients drugs that aren't available to the general public, others simply test two or more readily available medications against one another.

In the former scenario, patients stand to gain more if they have either run out of mainstream treatment options or if existing treatments' side effects are unacceptable, says Gunn Elisabeth Vist, an evidence quality researcher at the Norwegian Knowledge Centre for Health Services in Oslo. In the latter instance, a patient's decision to join the trial may have no impact on his health; Vist's research indicates that trial volunteers typically fare no better (nor any worse) than patients who receive similar care outside the context of a trial.

Anticipate the risks. Some studies involve only negligible risks. Letting researchers draw an extra vial of blood and review your medical chart, for example, probably isn't a big deal. Others—like the cancer trials that Grady studied and many of the trials that recruit healthy volunteers rather than patients with a disease—are inherently more hazardous. And health risks aren't the only dangers to be considered. Weinfurt recommends that would-be volunteers ask study leaders about who would have access to their personal medical data and how the data will be protected from unauthorized eyes. HIV patients, for example, "want to be confident that the data they supply will not be available to a whole bunch of people who might potentially be able to identify [them]," he says.

[See Medical Identity Theft Turns Patients into Victims.]

Consider the potential benefits. Certain studies are known as therapeutic studies, meaning that researchers hope the experiment will help participants. Nontherapeutic studies, by contrast, have little if any chance of improving volunteers' health. Each trial is also designated as a phase 1 study, which primarily examines a treatment's safety; phase 2, which in most cases investigates a treatment's most effective dose; or phase 3, which generally compares the treatment's efficacy against the best available alternative. Harmful or ineffective treatments are sometimes identified and abandoned at phase 1. That's one reason phase 3 trials are more often therapeutic and, according to some experts, more likely to be safe. "In general," Vist says, "the worst [treatments] are weeded out before they get to phase 3."

Don't get stuck with a whopping bill. An experimental treatment provided as part of a clinical trial should always be free to the patient, says Caligiuri. If a patient also receives conventional tests or treatments in the course of the trial, her health insurance should cover as much of that care as it would outside a trial. But insurers sometimes refuse to cover even the nonexperimental portion of volunteers' care, Caligiuri says. About 30 percent of the insured volunteers participating in trials at his hospital run into such insurance claims denials, he says. Denials tend to occur with Medicare Advantage HMO and PPO plans and with insurance plans that are based outside the state where the trial is taking place. To protect yourself, make sure your insurer is committed in advance to reimbursing appropriate costs.

Look for opportunities to save money. On the flip side, says Caligiuri, uninsured patients can sometimes get cutting-edge care for free by joining a clinical trial. A small fraction of cancer trials, for example, are conducted by community-based physicians rather than researchers at academic medical centers. Community-based trials tend to be funded by pharmaceutical companies that have a stake in getting results as quickly as possible—and may be loath to turn away willing volunteers for lack of complete insurance coverage. "It is often the case [that] the industrial sponsor will cover what is not covered by insurance," he says.