After my little rant yesterday about fatigue, we’ll get back on schedule today and talk a little about clinical trials.
What is a clinical trial? A clinical trial is a series of tests, research and drug development that helps to determine the safety and efficacy of a new drug treatment. They also document all of the adverse reactions seen during the trials.
There are several phases involved in a clinical trial, beginning with pre-clinical- non-human trials to test toxicity and determine what happens to the drug once introduced to a living organism (pharmacokinetic information). After they determine the general safety of the drug, they start testing the drug on healthy volunteers. The doses administered start as sub-therapeutic (less than a dosage that would be used to treat a patient), but do increase over time. This phase tests safety and efficacy of the drug. After the phase for healthy volunteers is completed they begin testing on patients. The doses given here are standard therapeutic doses, but it is presumed to have no therapeutic effects at this point of the trial. The next phase requires a larger number of participants (1000 or more). These patients are given therapeutic doses and at this point the drug is presumed somewhat effective. After this phase, the drugs are typically marketed to the public (under FDA recommendations and guidelines). At this point the long term effects of the drug are monitored, and research is continued on the data that was collected during the study.
To find out what clinical trials are out there, and whether or not you qualify, you can visit http://www.mpnresearchfoundation.org/Clinical-Trials, http://www.nhlbi.nih.gov/health/health-topics/topics/clinicaltrials/links.html, or http://clinicaltrials.gov/
Tomorrow we’ll be talking about support groups.