Patients take part in clinical trials for many reasons. While the treatment that you receive may offer you the best outcome, it is important to evaluate all of your options before you decide that a clinical trial is right for you. Here are some things to consider:
Medical Criteria
It is important to understand the specific treatment being offered in the trial and all of its potential risks and side effects, as well as how if differs from the standard treatments being offered. You will also want to know the eligibility criteria for the trial, so that you fully understand why you might be accepted or excluded. Know, however, that being accepted or excluded is determined by your general health match to the particular criteria of the trial protocol.
Personal Criteria
It’s important that you take many practical and emotional concerns into consideration before participating in a clinical trial. You’ll want to find out how long the treatment can take what time commitment is required, where the trial will take place and whether travel will be required. For your emotional well being, you want to know if you’ll have to change physicians and to what degree your family will be permitted to participate. Keep in mind that often you will have to interact with researchers and other additional healthcare personnel generating an increased attention to all aspects of your health.
Insurance Concerns
It is important to consider that not all clinical trials are covered by health insurance, or if they are, that all of the expenses may not be covered. While the trial sponsors often provide the drug at no cost, there are often many other costs associated with the trial, such as travel to and from a medical center where the trial is located. Medicare is now paying for clinical trials.
What Is Informed Consent?
Prior to enrollment in a study, a meeting with the patient and their family to review the consent form and discuss any questions related to the plan of treatment and side effects will take place. The consent form is a written summary of the study and the patient’s signature is documentation of agreement to participate in the study or treatment plan. According to the Food and Drug Administration (FDA) informed consent is more than just a signature on a form, it is a process of information exchange. The FDA further states that the entire informed consent process involves providing a patient with adequate information concerning the study, providing ample opportunity for the patient to consider all options, responding to the patients questions, ensuring that the patient has understood the information, obtaining voluntary permission to participate and, continuing to provide information to the patient as the situation requires. The informed consent process is most effective when there is an open exchange of information and questions between the patient and expert.
Researchers want to find the patients and the patients want to find the researchers; now that the internet can help researchers and patients find each other. Currently, only about 3% of cancer patients get into clinical trials. The feds recently ordered that Medicare begin paying for treatment in clinical trails which should increase the number of people in trials.
Clinical trials are not for everyone, but many more patients want clinical trials, but don’t know how to find out about them. Each clinical trial is going to have very specific criteria for including patients: you must have a specific disease, in Stage X, had certain treatments, but not others, etc. Matching the patients with the trials is the trick (see below).
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