Clinical Trials

Nationally, only about 5-10% of patients sign up for clinical research protocols. The number is so low for a multitude of reasons:
-some patient just do not like the idea of being “experimented on”
-travel can be an issue, because oftentimes large academic centers in big cities will offer clinical trials that patients are interested in
-patient may not meet eligibility criteria of a clinical trial, which do tend to be strict in some cases.
-Patient may not want to put up with the extra paperwork and hassles of being in a clinical trial

That being said, it is entirely up to the patient whether a clinical trial is “right” for a patient. A lot of this will depend on the specific clinical trial in question. A detailed discussion with the physician charge of the clinical trial at a particular institution will really help.

If you are interested in clinical trials, the best resource is www.clinicaltrials.gov . You can find any clinical trial internationally on this website, and do a detailed search.

FAQ:
what does a Phase 1, 2, or 3 trial mean?
A Phase 1 trial is often time a “first in man” testing. The particular drug has already received animal testing, and some basic information is known about side effects. It is not particularly well known whether the drug actually works in humans against cancer. The purpose of a phase 1 trial is to determine the right dose for a human. Different doses of the drug are given in a Phase 1 trial. Phase 1 trials will often take patients with any type of cancer who are refractory to conventional treatment. If the drug happens to work against a particular cancer, that is an added bonus. Phase 1 trials are often criticized by patients as “experiments”, but they are essential to determine side effects of a new drug.
A phase 2 trial is performed after a phase 1 trial. At this point, the drug is usually given at a fixed dose in patients with a particular type of cancer. The purpose of the phase 2 trial is often to determine if there is a significant enough response rate to proceed to phase 3 testing.
In a phase 3 trial, the experimental drug is pitted against what is considered “standard of care” (which may not always be what we use in real life) to determine if the experimental drug can “beat” the standard of care. If a phase 3 trial has been properly conducted and the experimental drug “wins”, the pharmaceutical company or institution in charge of the phase 3 trial will then ask the FDA for approval of the experimental drug.

 






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