Will You Have Access to Those Drugs That Work After a Trial Is Complete?
Understandably, if an investigational drug helps you, you may wish to continue to take it after the trial has been completed. In some instances, a medication that is being investigated for use in treating your illness may have been approved by the Food and Drug Administration (FDA) for other uses. If you find that you benefit from such a medication, your own doctor can prescribe it for you.
Often, the company developing a new drug may try to see that you can continue to get it, even before the FDA has approved it for sale. You may be able to do this under what is termed a compassionate plea basis. This means that because the new drug has been so helpful, the manufacturer can give it to a physician, who may then prescribe it for you.
While companies often make such a new drug available, there may also be good reasons why a company cannot. Perhaps only a very small amount of a drug was prepared for the research project, and no more is available for use afterwards. Then again, a manufacturer may want to further test the drug under certain conditions, or to examine the results of a research study more fully before releasing it for compassionate plea use. A company would be especially careful if a new medication required that the doctor who prescribed it have some special knowledge or skill to monitor its safe use.
You and any family members interested in your well-being should discuss with the director of the research your questions about compassionate plea use. Each case is different, so the agreement has to be between the drug manufacturer and your own doctor.
If you decide to take part in a research study and, especially one that takes place in a hospital you may find that you will have to stop, or interrupt, the care you now are getting for a mental disorder. Doing that, even temporarily, may result in your losing access to a program of personal care that had been expensive and hard to come by. The director of research on your study often will help you to get back into a program of care when the study is finished. The investigator’s institution may assist in arranging for follow-up care.
Psych Central. (2013). Will You Have Access to Those Drugs That Work After a Trial Is Complete?. Psych Central. Retrieved on April 26, 2015, from http://psychcentral.com/lib/will-you-have-access-to-those-drugs-that-work-after-a-trial-is-complete/000417