Bioethics

Is participating in a clinical trial dangerous?
Answered by Bambi Turner and Discovery Channel
  • Bambi Turner

    Bambi Turner

  • Discovery Channel

    Discovery Channel

  1. Medical researchers in the U.S. rely on clinical trials to test the safety and effectiveness of new drugs and other forms of treatment. Millions of people participate in these trials each year in an effort to help others, teat their own health conditions or simply to earn a little money [source: Northwestern Memorial Hospital]. Strict oversight by the Food and Drug Administration (FDA) and other health organizations means these trials pose relatively little serious risk for most participants.

    Of course, no clinical trial is 100 percent safe. There's always a risk that the prescribed treatment may not work, or even worse, that it can lead to serious health problems or even death. In 1999, 18-year old Jesse Gelsinger took part in a clinical trial at the University of Pennsylvania. Researchers were studying a rare metabolic disease that Gelsinger had, although his condition was well under control at the time, allowing him to live a normal life. Just a week later, he died from injections he received during the trial [source: Spector]. In 2001, a medical assistant named Ellen Roche participated in a trial designed to test a new asthma drug. Although Roche was healthy and asthma free at the start of the trial, she died shortly after from chemical exposure during testing [source: Worley].

    Although clinical trial-related deaths are extremely rare, all participants should take the time to review the potential dangers associated with each trial before agreeing to participate. For many, this comes down to weighing the benefits of taking part against the risks that something could go wrong. Patients with serious health problems may be willing to test experimental medications based on the hope that these drugs can improve their quality of life. People who are simply looking for a way to earn cash may be willing to participate only in relatively benign tests, as the risks of certain trials could outweigh the rewards for these participants.

    Clinical trial participants should also be aware of the potential risks associated with different phases of these trials. In the U.S., Phase I trials are typically the most dangerous. In a Phase I clinical trial, researchers try out a new drug or treatment on humans for the very first time. This phase is preceded by research and animal testing, but it still exposes test subjects to any number of unknown risks [source: University of Michigan School of Public Health].

    Another way to mitigate risk when choosing whether to take part in these trials is to be on the lookout for conflicts of interest. The FDA warns that some medical staff receive financial rewards when they sign people up for clinical trials [source: FDA]. This could lead workers to accept candidates who may not be the best choices for a particular study. 

    Paul Gelsinger, whose son Jesse died during the University of Pennsylvania clinical trial, also points to conflicts of interest among researchers. Many have financial stakes in their experiments, and could be influenced to sacrifice ethical standards in their efforts to reap these financial rewards [source: Spector]. Protect yourself by asking how the study has been sponsored and where the results of the trial will be sent. Finally, remember that you are under no obligation to see a clinical trial through, and are free to quit any time without penalty if something doesn't seem quite right.


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  2. Many people turn participating in clinical trials into a mini-career: Acting as test subjects for new drugs and other medical treatments can pay somewhat well --sometimes as much as $100 to $200 per day. But is this a dangerous line of work?

    As a volunteer, you are typically supervised throughout the trial by professional researchers and even doctors. The government requires that every trial be approved at the hospital or university where it's being conducted by an Institutional Review Board, which usually includes physicians, researchers and even community advocates [source: Clinical Trials.gov]. This helps ensure that the trial is ethical and safe.

    Participating as a volunteer subject in a clinical trial still involves varied levels of danger, however. When volunteering, participants often are serving as the first human test subjects for new drugs. Risks including everything from discomfort to permanent physical damage to death. Even with these risks in mind, many people who participate in clinical trials often continuously look for new opportunities to volunteer in future studies.

    Before the 1970s, regulations around clinical drug trials were much less strenuous, and prisoners and conscientious objectors often were used as test subjects. They participated in exchange for sentencing leniency or noncombat assignments. In the past, drug companies and government agencies were not even required to tell subjects about the drug being tested or the objectives of the research. Today, there is much more government oversight and a much greater degree of regulation of clinical trials. Anyone who meets the inclusion criteria of the test can be a subject, and subjects are told that they can exit a trial at any time if they so choose.

    Today, participants must sign informed consent documents, saying that they understand the risks of the trial and its research intent. Privacy laws also protect participants and some research has been known to stop mid-trial if the testing has appeared to be too dangerous



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