Before beginning a clinical trial on human subjects, it must be reviewed by and approved by the FDA and an Institutional Review Board (IRB). The FDA reviews the known information about the drug and the proposed plan for the clinical trial. An IRB is an ethics committee that reviews the trial making sure that the patient’s rights and safety are protected and that the trial is scientifically sound. The trial itself is conducted by qualified doctors and other healthcare professionals.
Phase I- After testing in animals, the medication is evaluated in healthy volunteers to further evaluate how the body processes it and to look for side effects.
Phase II- The medication is evaluated in patients with the disease to further evaluate how the body processes it, to look for any side effects, and to estimate the dose needed to treat diseases.
Phase III- The medication is evaluated in volunteers with the disease to gain further knowledge about its effects in the body and effectiveness in treating the disease.
Phase IV- Continued trials to further evaluate the medication, its effect in the body and effectiveness in treating the disease and new diseases. This phase is typically done after the treatment has been FDA approved for general use.
Depending on the medication or device being evaluated, different trials will last different periods of time. For example, a trial may only require one visit. Others may last several months to a few years and require regular visits such as on a monthly or quarterly basis.
Participating in a clinical trial is completely voluntary. Sometimes people withdraw from a trial for reasons such as moving out of the area, other obligations to their family or job preventing them from keeping their appointments, or the medication is not working. Sometimes, the doctor may remove a patient from the trial due to changes in their health condition. You are free to withdraw from a trial at any time for any reason with no penalty to you.
Yes. Confidentiality is maintained throughout the clinical trial including adhering to all HIPAA standards. All study related information is kept separate from your regular medical records. Your insurance company will not be sent any information and will not receive any bills for study related care. If you desire, your personal medical doctor can be informed of your participation. When results are sent to the FDA or if they are published in a medical journal, your identity will be kept confidential.
There is no cost for you to participate and you do not need medical insurance to participate. You will be compensated for your time and travel. Your personal doctor does not need to approve your participation, but we will notify him/her of your participation if you desire. Your insurance company will not be notified of your participation and they will not be sent any bills for any study related activities.
A clinical trial is an opportunity to participate in the future of medicine. Information gained may very well benefit you or a loved one as well as society in the future. Many patients feel a great satisfaction in “participating in the process” and “helping the next person”.
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