Clinical trials are the means by which new drugs and treatments are tested to determine if they work. They are the engine that drives progress in medicine. For patients who have run out of other options, clinical trials offer a last chance at a potentially effective therapy. In some cases, they provide access to research treatments before they are made widely available.
But it’s important to remember that clinical trials often involve unproven therapies. There is no guarantee that the treatments under investigation will work. And there is always a chance that they may cause serious side effects. Still, by participating in clinical trials, patients help advance the science of medicine.
Are There Guidelines to Participate in a Clinical Trial?
Yes. If you or someone you know is interested in participating in a clinical trial, there are some important things to remember.
Clinical trials have specific guidelines about participation. To make sure clinical trials are safe and provide reliable scientific information, researchers carefully choose who can — and who can’t — take part. Clinical trials include “inclusion criteria” (the requirements for participating) and “exclusion criteria” (factors that disallow people from taking part). These are usually spelled out in descriptions of clinical trials made available to the public.
Participants must be informed and give their consent. Doctors and nurses are required to explain the details of the investigation to prospective participants. They also provide an “informed consent” document, with the details of the study explained in writing. Participants are asked to sign the document. Additional information is sometimes provided during the study, as it becomes available.
Participants are always free to withdraw from a study. Even after you sign an informed consent document and join a clinical trial, you can withdraw at any time.
Withdrawing can jeopardize research, however. So it’s important to learn everything you can before agreeing to join a trial.
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