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What To Ask About Preliminary Results
If you're considering participating in a clinical trial or you have already volunteered to participate, you have the right to some very important information. Although the information should be offered to you, if you don't get it - ask!
You are supposed to be informed of all preliminary data that have been generated. If laboratory and/or animal and/or human studies were done previously and those studies showed anything of importance to the clinical trial, you should be informed of it. Examples would include a list of side effects and their frequencies, safety and effectiveness of a drug at the doses tested, and the maximum dose which participants could tolerate, if known. This is a partial, not exhaustive, list.
If the oral or written explanations given to you do not include such information, ask for it. Ask for it directly, using questions such as:
The more you know about what is known, the less chance you'll be disturbed by a surprising result of your own participation. On the other hand, knowing a lot about preliminary results may be discouraging or even frightening. Have you ever actually read all of the possible side effects warnings of even the most common over-the-counter drugs? If you read them closely and then take the medication, you're bound to experience some (or all!) of the side effects.
Finally, if you feel you are not being given all of the available information, don't volunteer for the study. And if you're already in a clinical trial and you believe you're not being told about current findings, then it's probably best to withdraw from the study.
If the article on the results of the Merck-sponsored clinical trial of Vioxx had been more forthcoming with the cardiac problems which were observed, then there might be less finger-pointing (and perhaps less law suits!) directed at Merck.
-Joe
Related Topics: Is a Clinical Trial Right For You?, Clinical Trial Listing
You are supposed to be informed of all preliminary data that have been generated. If laboratory and/or animal and/or human studies were done previously and those studies showed anything of importance to the clinical trial, you should be informed of it. Examples would include a list of side effects and their frequencies, safety and effectiveness of a drug at the doses tested, and the maximum dose which participants could tolerate, if known. This is a partial, not exhaustive, list.
If the oral or written explanations given to you do not include such information, ask for it. Ask for it directly, using questions such as:
- Has this drug (or treatment or test or device or whatever) been tested in humans or animals before? What did such tests show?
- How were the results of the previous tests used in the design of this study?
- What side effects were seen in previous studies? If so, what were they and at what doses?
- Did anyone die on a previous study? If so, at what dose?
The more you know about what is known, the less chance you'll be disturbed by a surprising result of your own participation. On the other hand, knowing a lot about preliminary results may be discouraging or even frightening. Have you ever actually read all of the possible side effects warnings of even the most common over-the-counter drugs? If you read them closely and then take the medication, you're bound to experience some (or all!) of the side effects.
Finally, if you feel you are not being given all of the available information, don't volunteer for the study. And if you're already in a clinical trial and you believe you're not being told about current findings, then it's probably best to withdraw from the study.
If the article on the results of the Merck-sponsored clinical trial of Vioxx had been more forthcoming with the cardiac problems which were observed, then there might be less finger-pointing (and perhaps less law suits!) directed at Merck.
-Joe
Related Topics: Is a Clinical Trial Right For You?, Clinical Trial Listing
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