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Experimental Treatments? Unapproved But Not Always Unavailable

Is the Risk Worth It? continued...

5. How do I know if I am eligible to be in the study?
Every trial has a set of criteria to select the people that will be included in the study. These criteria generally relate to general health, stage of disease, and prior treatments and are designed to produce useful scientific information.

6. Do I have to pay to be in a clinical study?
Generally, studies funded by the federal government are free for the patient. Many studies funded by drug companies also do not cost anything. Some costs, however, may be paid by a patient's health insurance or managed-care plan.

7. So I'm just a guinea pig, right?
By the time most studies reach the stage where the new drug is being tested in people, a great deal is known about how it affects the body. While there is always the chance that something could go wrong, the safety of most drugs being studied is well understood. It is true, however, that researchers do not know if a treatment being studied works better than current therapies or not.

What FDA Does Not Do

Although FDA is responsible for overseeing the field of drug development, there are a number of services the agency cannot provide to individual patients. For one thing, it cannot give out the name of drugs in development, a common request from patients who call the agency. Unless the company publicly releases information about the experimental treatment, FDA is currently forbidden to even acknowledge that it knows about the drug.

Along the same lines, FDA cannot make the drug available to individual patients or physicians. The agency simply does not have the product; only the company that is developing the drug has a supply. And FDA has no authority to require that the company make its drug available outside of the clinical trial.

FDA, itself, does not conduct any clinical trials or drug studies. The agency carries out its drug review and approval responsibilities by examining clinical and other data generated by the drug company.

And lastly, FDA does not give advice. While staff from the Office of Special Health Issues and the Center for Drug Evaluation and Research's drug information branch will often provide detailed information and explain the process for getting access to an experimental medication, the agency does not steer patients in one direction or the other. Information is provided so patients, in consultation with their physicians, can make their own informed decisions.

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WebMD Public Information from the FDA

Reviewed by Gary D. Vogin, MD on April 04, 2002

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