How does a clinical trial sponsored by a pharmaceutical company differ from those administered through a medical center, the NCI, or some other research institute? Should one ask different questions or have different expectations?
Posted: 30 Sep 2005 10:29 AM Originally Posted: 29 Sep 2005 08:24 PM
Thank you for contacting us at The University of Texas M. D. Anderson Cancer Center regarding clinical trials.
Your initial question yields two different answers based on the word "sponsor". One answer deals with the financial aspect of the trial for the patient and the other one deals with the running/conducting of the trial.
If a pharmaceutical company works in conjunction with a medical center and it "sponsors" the trial, then the cost of the drug/treatment itself is paid for by the pharmaceutical company. However, the medical center sets the criteria and the trial is subject to the medical center's review panels and Institutional Review Board (IRB). Nevertheless, in many instances, the patient or the patient's insurance company would be responsible for usual care costs, such as doctor visits, and extra care costs, such as additional testing that may be required for the clinical trial.
Pharmaceutical companies also conduct or "sponsor" their own trials. By this, the trial is subject to the companies' own review panels and to their own IRB. This is true even if the pharmaceutical company partners with a medical center, physician, etc.
The questions to ask are fairly similar in both instances. The following are examples of questions to ask when considering a clinical trial:
What parts of treatment, if any, does the trial provide free of charge?
What parts of treatment must be paid for by me or my health insurance plan?
What is the situation for people who have no health insurance?
Will my total charges be higher as a clinical trial participant than if I opt for standard care?
Why is this trial taking place?
Why do the doctors who designed the trial believe that the treatment being studied may be better than the one being used now?
How long will I be in the trial?
What kinds of tests and treatments are involved?
What are the possible side effects or risks of the new treatment?
How could the trial effect my daily life?
There are many other questions to consider and more information to research before participate in a clinical trial. To learn more, please visit the website for The National Cancer Institute (NCI) at the following exact link: http://www.cancer.gov/clinicaltrials/learning
I hope that this information is helpful. If you would like any additional information about M. D. Anderson services, programs, or appointment information, do not hesitate to contact the M. D. Anderson Information Line at 1-800-392-1611, option 3.