Risks Of Clinical Trials
Regardless of phase, all clinical trials entail some risks to the patient. The primary risk is that the treatment may not work and the patient may continue to get worse. In addition, because trials are offered in limited settings, being in a trial may involve additional time, travel, expense and effort on the part of the patient. Since one of the primary objectives of a clinical trial is to establish the safety of the treatment, it stands to reason that some participants may experience side effects that could range from being uncomfortable to being life-threatening.
Despite the experimental nature of clinical trials, the institutions that offer them are committed to minimizing the above risk as much as possible. The goal, after all, is to find a treatment that will help the patients, not harm them. This process is aided by the requirement that clinical trials must be approved by an Institutional Review Board (IRB). This is usually composed of researchers, institutional management and community members who evaluate the protocol or study plan for safety. Clinical trials must adhere to the same legal and ethical standards that apply to general medical practices. In addition, most American clinical trials are registered with and regulated by the United States government to ensure consistency and enforcement of standards.
Great efforts are made to ensure safety for patients participating in clinical trials. Still, risks remain. These risks are greater in Phase I and II studies than in Phase III or IV studies. Discuss possible risks with your doctor. Before you enter a trial, your healthcare provider will talk with you in detail about the risks and benefits of the treatment.
Some patients are concerned that they will be “guinea pigs” for medical science if they participate in a clinical trial. In Phase III cancer clinical trials, the new treatment being tested is compared with the standard treatment. This means that in most cases a patient will be receiving at least standard treatment for their cancer. If a placebo is used in a trial you will be informed verbally and in writing about your chance of receiving the placebo.
Not all treatments work for all people. Clinical trials offer patients one more treatment option. They represent an opportunity to receive up-to-date treatment and contribute to medical science and humanity at the same time. The good that can come from a clinical trial generally outweighs the risks.
If you decide to join a clinical trial, you will be asked to sign an informed consent form. This document is required by all institutions. When you sign the informed consent, you are stating that you have discussed the clinical trial with your doctor or nurse, that you have been told about the possible risks and benefits, and that you are participating in the trial because you want and choose to do so of your own free will.
Before you join a clinical trial, talk with your healthcare providers about the specifics of the trial. You may also want to talk with a researcher who is administering the trial before you make your decision.
Ask questions such as:
• What does the trial hope to accomplish?
• What side effects might I experience? Are these worse than those I might experience with standard treatment?
• Who is sponsoring the trial?
• What should I expect if I am in the trial? What should I expect if I am not in the trial?
• What are the possible benefits to me and my family if I go into the trial?
• Will I have to pay for the treatment? Will any of the treatment be free?
• Will joining a trial keep me from being treated with other therapies, either now or later?
• Whom can I call if there are problems while I am in the trial? What phone number should I call in the evening or on weekends?
Be aware that some healthcare providers are reluctant to have their patients participate in clinical trials. This may be due to any number of reasons, including:
• some healthcare providers may be generally concerned about their patients participating in medical research
• some may be concerned that their patient’s participation in a clinical trial will result in more work for the professionals and that their time is already very limited
• others may worry that patients cannot withstand the more frequent office visits that might be required
• still others may believe that a standard treatment regimen will be best
The information provided about a trial includes a list of researchers and information on how to contact them.
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