Clinical Trials & Studies; What to Ask Your Doctor Before Participating
What To Ask Before Participating in a Clinical Trial
All new medications, surgical procedures, and techniques to help spinal cord injury patients must be tested on human patients before receiving final FDA approval. Clinical trials are studies which test these new treatments on patients. Legitimate clinical trials are designed to minimize possible risks to patients during the trial, while hopefully offering benefits that the patients could not receive from conventional treatments now available. Every year, across the United States, numerous clinical trials directed at helping spinal cord injury patients are conducted in various locations.
Researchers must have previously tested any new treatment method or medicine in the laboratory, before it is allowed to be used in a clinical trial. The FDA has strict guidelines for the running of clinical trials. FDA regulations require that new medical treatments be tested in three successive phases of clinical trials, before the treatment receives final FDA approval for use on patients.
Testing Phases of Clinical Trials & Studies
Phase I Clinical Trials
During the first phase of testing, the safest way to deliver a new treatment or the safest dosage of a medication will be determined. In the case of medication, the lowest possible dosage will at first be given to the initial volunteers in the trial; later, if the initial dosage is found to be safe, the dosage may be increased for the next group of participants in the trial. New techniques, such as new surgical procedures, will likewise be tested with extreme caution. During a phase I study, the main goal is to determine if the treatment is safe; phase II and phase III trials will focus on the treatment’s effectiveness in helping spinal cord injury patients.
Phase II Clinical Trails
If the treatment or medicine is found to be relatively safe during the first phase, researchers will then begin to assess its effectiveness in helping spinal cord injury patients. Phase II clinical trials involve a limited number of participants who are given the dosage of medication or method of treatment that proved reasonably safe in phase I of the trial. If the treatment seems to be effective for a significant number of these participants, researchers will proceed to phase III.
Phase III Clinical Trials
By phrase III of the clinical trial, the researchers have enough evidence on the treatment’s safety and effectiveness to begin using it on a wider-number of participants. A phase III trial may be conducted at locations across the nation and sometimes internationally. This allows a wide number of patients who may benefit from the trial to be able to take part in it and it allows researchers to test the treatment on people with various degrees of injury and varying degrees of overall health.
If you are going to take part in a phase III trial, you should be aware that you may or may not be chosen to receive the new treatment. To test the new treatment’s effectiveness when compared to the current treatment, participants in a phase III trial are divided into a control group and an experimental group. People in the control group receive a standard treatment for their condition, while people in the experimental group receive the treatment being studied. During the study, patients will not be told which group they are in. Sometimes more than one experimental group is used; this allows researchers to further refine the dosage of medication or the technique being studied by using variations of the treatment on the different experimental groups.
Not knowing which group you are in may seem unfair or even frightening, but it is the only way to accurately study the new treatment’s effectiveness, since knowing you are receiving a new treatment can influence your reaction to it. Researchers must be sure the treatment itself is causing any improvement shown, rather than any suggestions to the patient about the effectiveness of the treatment. If you are thinking of applying for a clinical trial, do not allow the need for secrecy about the group you will be placed in deter you from participating; researchers are required by law to disclose all other information about the trial to the participants. After the trial you should be briefed on all aspects of it.
Remember that you are the only one who can decide if you wish to take part in a clinical trial. The medical professionals responsible for caring for your injury can advise you if a particular trial is appropriate for you, but they cannot make your decision; only you have the right to make this possibly life-changing decision.
Before you take part in a clinical trial, the researchers will verbally explain the trial procedures and goal to you and they will also put the information in writing for you. This assures that you are able to give informed consent to the procedure. To participate, you must sign a written consent form which states that you understand the benefits and risks involved in the trial. Once they are age seven or older, children participating in a clinical trial, must also give their written consent to participate (along with parental consent). You will be free to withdraw from the trial at any time, even though you have signed a consent form. Throughout the trial, the research team will keep you informed of the benefits and risks of continuing to participate.
What to ask your Dr. before participating in clinical trials
Although the researchers conducting the clinical trial should give you ample information, it is crucial that you inform yourself before deciding to enroll in a clinical trial. Discuss your options with your spinal cord injury medical team. The following questions can help you find the best clinical trial for your condition:
• What clinical trials might I qualify for?
• What is the purpose of this trial?
• Is the trial being ethically conducted?
• Has this procedure or medicine been used on human patients before now? What were the results if it was used on humans?
• Has the treatment been used specifically for spinal cord injuries?
• What types of procedures and tests will be used in this study?
• Would I need to stay in a hospital or treatment center while the study is being conducted?
• Will the treatment interfere extensively with my life or my ability to do things?
• How long will the trial last?
• How frequently will I need to participate?
• Explain the possible side effects of this treatment.
• What can I expect if I do not participate in this clinical trial?
• What other treatment options are available?
• If I am harmed by the study, will I receive treatment?
• Will I have to pay anything for the treatment?
• Will I be given follow-up care after the study?
Taking part in a clinical trial is a personal decision that should be made only after you have calmly considered the pros and cons of being a part of such a study.
A note of caution: There are some unscrupulous people offering fraudulent cures and ‘clinical trials’ that are not properly run. Do not participate in a clinical trial which requires you to pay for the experimental treatment; this is not ethical and it is a sign that the trial is not legitimate or safe.
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