What are the possible risks or downsides of enrolling in a clinical trial?
Frequently, enrollees must submit to additional tests and visits to the doctors’ office to monitor their progress. There is a commitment of time and travel associated with most trials. Because there are no guarantees with trials, the participant may not derive any benefit from the treatment and may even experience adverse side effects, minor or potentially life threatening. Some participants may be randomly placed in a group that does not receive any treatment of the trial drug or may receive a placebo (a nondrug substitute). Please be aware that Phase I trials are not designed to show effectiveness; they are designed to show that the drug is not toxic in humans. Little is known about the drugs in Phase I trials, because this is when they are usually tested in humans for the first time or are evaluations of a new dosage or new mode of administration.
