Many of us have heard about clinical trials, but I wonder how many of us have given much thought about being in one? It sounds like a daunting experience, but actually it is a good way to play a more active role in our health care, be exposed to new, cutting edge treatments and help with scientific data. Clinical trials are biomedical or health-related research studies in humans that follow a pre-determined protocol.
I talked about "inclusion/exclusion" criteria a while back. That's where participants are "included" or "excluded" from a clinical trial due to certain standards that researchers have set. Clinical trials usually run in four phases. Phase I is performed with a small group of people, between 20-80, checking the safety and dosage of the experimental medication and marking any side effects. Phase II studies the safety of the drug (or other treatment) which is administered to a larger group of people - 100 to 300. In Phase III, the participating group swells to between one thousand and three thousand people. During this phase, the experimental drug's efficacy is confirmed, side effects are monitored, it's compared to other treatments and information is collected to see if the experimental drug can be used safely. The last is Phase IV. This is when the researchers outline the post marketing studies, including the drugs risks, benefits and best way to use it.
Check out our updated listings of Current Migraine and Headache Clinicial Trials
© Nancy Harris Bonk
Last updated February 27, 2010.
Published On: February 28, 2010