Clinical Trials: Innocent or Guilty

One of the decisions you may face is your doctor’s or surgeon’s request that you par-
ticipate in a clinical trial. Lest you think you’ve been asked to become a human
guinea pig, know that prior to subjecting patients to this new treatment, the research
protocol undergoes stringent review by a board of scientists, doctors, nurses, and
laypersons. In most cases your risk is minimal, but you may have some real benefits.
Be assured that you cannot be placed in a clinical trial without your explicit permis-
sion, which includes your signature on a document called an Informed Consent
Form. Sometimes quite lengthy and detailed, this form must …
➤ Explain the rationale.
➤ Identify who is and is not eligible.
➤ Describe the procedure.
➤ Detail potential risks and benefits.
➤ Name the research participants (doctors, surgeons, etc.).
➤ Address concerns such as confidentiality, cost, and who to call if you have ques-
tions about your rights or the safety of this study.
Yes, there are justifiable cheers and jeers for partici-
pating in any clinical trial. The trials are so far-
reaching in scope, however, that it’s impossible to
say here whether or not you should participate. You
have to ask the usual informed-consumer questions
of your doctor and of the research group involved.
And, of course, you’ll want to check with your in-
surance company to make sure you’re still covered
The advantage of a clinical trial is that you are
getting state-of-the-art treatment that has shown
promise of being better than the best treatment
currently available. Be cautious, however, if your
doctor is part of the study. Certain pressures—
financial, professional, or personal—may (but not
necessarily) influence his or her decision to want
you on board. Be sure it’s in your best interest.
Even if you sign on the dotted line, you can decide to leave the study at any time. Or
your medical team can remove you from the study. Either way, your further treat-
ment won’t be jeopardized.