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Clinical Trials- Were you Unknowingly Put at Risk?

Over 80,000 clinical drug trials take place in the United States every year. By and large, these trials are safe and well-planned and do not cause any harm to the participants. However, it’s not that uncommon to read about a clinical drug trial that was stopped for safety reasons. What does that mean? It means that the drug was doing more harm than good for the people who were taking it. Trials can also be safe in general, but harmful to just a few people. For instance, a participant in the program might suffer an allergic reaction to the drug that very few others had.

The sponsors and investigators who run drug trials have certain responsibilities to the subjects who participate in the clinical drug trials. If you have been made sick or suffered some other harm from participating in a clinical drug trial, you may have the right to pursue compensation by filing a Dallas product liability claim. A product liability attorney can guide you through the legal and medical maze that this situation presents.

First, with the help of your Dallas personal injury lawyer you will need to determine if the trial was set up and carried out properly. Here are several questions to ask about clinical drug trials.

1. Did you have an allergic reaction, infection or other illness during your clinical trial? Were you told you might have this reaction?
2. Did the researchers tell you that the Food and Drug Administration (FDA) had not yet approved the drug you were taking?
3. Were you able to understand completely the consent document you signed before the trial? Consent documents must be written at or below an eighth-grade reading level. If you had trouble understanding the document, it may have been written at too highly technical a level.
4. Do you feel that those assigned to monitor you during the trial were well-trained?
5. Do you believe that you were not, in retrospect, a good candidate for the trial? Screening for clinical drug trials should be a very selective process, but researchers are often paid for signing participants up, leading to shortcuts in the screening process.
6. Did you feel pressured at all to join the clinical drug trial? Participating in a trial must be completely voluntary.
7. Do you believe the investigators had or have a financial interest in the pharmaceutical company sponsoring the trial? Investigators are, of course, paid for their work, but they should not, from an ethical standpoint, have a financial stake in the drug company. If they do, this should have been disclosed to you.
8. Were you promised a cure for a disease or condition? Clinical drug trials may not make any promises as to the efficacy of the drug being tested.
9. Was the FDA informed of your adverse reaction during the trial?

A product liability attorney can help you answer these questions and others that may be pertinent to your experience. Based on your answers, you may be able to file a Dallas product liability lawsuit against the pharmaceutical company sponsoring the trial or the investigators operating the trial. If you are the victim of an error, you deserve compensation.

RASANSKY LAW FIRM
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Dallas, Texas 75201
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