What Are Your Risks and Benefits in a Clinical Trial?

Clinical trials involve new drugs for treating diseases.
Clinical trials involve new drugs for treating diseases. Morsa Images/Getty Images

Patients often wonder about the risks and benefits of clinical trials. After all, a clinical trial is an experiment, with no guarantees that it will improve one's health, and the possibility that it could cause further health problems.

The Benefits of Participating in Clinical Trials

  • If you have a disease that cannot be treated with an existing drug or regimen, participation might provide you with a successful treatment before it becomes available to others.
  • If you are debilitated in some way, you may have the opportunity to test a regimen that would improve your quality of life.
  • If you are qualified to participate in a study for a particular disease or condition, and you have had trouble finding good care for your disease or condition to that point, you may find access to improved care since the investigators involved in the study focus directly on the medical problem being studied.
  • The drugs and protocols offered during clinical trials are often provided at no cost to participants. Patients who have trouble affording the drugs or treatment they need may consider enrolling in a clinical trial in order to access the protocols that may help them.
  • Some patients have no alternatives for treatment and permanent debilitation or death are imminent. In such cases, participation in a clinical trial may give them hope or possibilities that do not exist otherwise.
  • You may have interest in the humanitarian reasons to participate. For example, many drugs, devices, and therapies have previously been tested on white men and found safe and useful. Fewer trials have been designed and run for women, minorities, or children. Participation in a trial that broadens the use of a good drug for one of these less-tested groups is useful to humanity.
  • Perhaps you are just curious about a treatment possibility and fit the profile needed for the trial.

The Risks of Participating in Clinical Trials

  • Patients do not know whether they are receiving the experimental drug or treatment, or a previously approved drug or treatment, or even a placebo (a dummy treatment). Therefore, if the reason you decide to participate is because you hope to try a treatment that is not yet publicly available, you usually have, at best, a 50% chance of receiving that treatment.
  • There may be side effects or outcomes that are unpleasant. They may last only a short time, or they may affect you for the rest of your life.
  • The treatment being studied may have no positive effect, either because you aren't really receiving the treatment being studied (see above) or because the treatment isn't appropriate to help you.
  • The time and attention required of participants may be long and involved. It may require hours of testing, miles of travel, hospital stays, or complicated dosing.
  • New doesn't always mean better.
  • Not all clinical trials are as objective as they need to be. Ideally, they are set up to be totally objective, but patients are wise to look at who/what organization is doing the investigating to be sure the study is not biased by financial gains that can be made from any specific outcome.

    For example, a drug manufacturer may have developed a new drug for asthma. It may set up a clinical trial that compares its new drug against a drug already being sold by its competitor. Smart patients and their doctors know to look at possible bias in these kinds of results since proving the new drug is better will clearly reap profits for the manufacturer of the new drug.

    How to Weigh the Risks and Benefits of Participating in Clinical Trials

    In order to participate in a clinical trial, you must be deemed eligible to do so by a number of criteria. Once you know you are eligible, and you've considered the risks and benefits above, you will want to ask a number of questions of your doctor or the investigators to determine whether participation is worth your effort.

    Once you are satisfied with the answers to the questions and others you may think of, you will be ready to decide whether you want to participate in the trial.

    Informed Consent

    Before you are allowed to participate, you will be asked for your informed consent which indicates you understand the answers to your questions and accept the terms of the trial.

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