How to Get Involved -- Participating in a Clinical Trial
by Brendan Milliner and Lisa Rotenstein
Phase 3 Trials
Enrolling in a clinical trial can be a good way to explore new therapies and gain access to cutting-edge medications that haven't yet been approved by the FDA. It is also often a great way to learn more about your diabetes (or another condition if the trial is for another disease!). Everyone that participates in a clinical trial goes through an informed consent process. They will hear about all the known risks and benefits and everything that will be involved in their participation. After getting all this information, they can then choose whether or not to participate in the study. Most clinical trials are blinded and randomized, which means you won't know whether you are on the test medication, a comparator drug, or a placebo “dummy pill.” It is important to know that you and the doctor won't have any say in the treatment that each individual participant receives--treatment groups are randomly assigned, and neither you nor your doctor will know which treatment you are getting. This helps with reducing bias in trials, but is important to know before you participate. At the same time, clinical trials are just that-trials-and so not all questions about these drugs have been answered.
One way to get involved with a trial is to ask your doctor-many doctors are involved with or lead trials, or just know about trials taking place. You can also go to several websites to see if you'd qualify for any trials or some of the drugs being tested might meet your needs:
- JDRF Type 1 Clinical Trials Connection
- American Diabetes Association Trials
- Federal Government Trials:
How to find out about or report drug side effects
The FDA plays an important role in monitoring the safety of drugs even after they get to market, and as a member of the public you have access to FDA safety warnings. Also, you can do your part in informing others by reporting side effects that you experience while on a medication. Both the FDA safety warnings and the reporting system can be accessed through MedWatch.
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Last Updated: Tuesday December 08, 2009 11:12:14
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