Participating in Clinical Trials
At some point, your doctor may ask you if you want to participate in a clinical trial. Unless you are well-informed on the subject of clinical trials, it may either seem like a scary proposition or the chance of a lifetime.
People who agree to participate in clinical trials do so for different reasons, but there are benefits and risks associated with clinical trials that must be understood. Don't enter into it lightly, but don't disregard the benefit which could come from your participation.
Ask your doctor what he feels about how the trial will benefit you as opposed to being treated with medication that is already being used for your condition. Be aware that physicians may get a generous reimbursement from the pharmaceutical companies sponsoring the trial, so determine to the best of your ability that it is in your best interest to participate.
Some people choose to participate in clinical trials because they have failed all other standard treatments, while others are motivated by a responsibility to help find better treatments or a possible cure. It's a way to personally contribute to the effort. Still others are motivated because some companies will compensate patients to participate in their studies.
Clinical trials are human studies designed to evaluate the efficacy and safety of a possible new treatment before it can be recommended by regulatory agencies for approval and marketing. There are four phases of clinical trials:
Phase I involves few study participants, and it is decided how and how much of a medication or treatment should be given.
Phase-II trials study the effect of the experimental treatment on a specific disease.
Phase-III trials compare the experimental treatment to what is considered standard treatment for the specific disease or condition.
Phase-IV clinical trials study the effectiveness of the experimental drug in combination with other effective drugs, and are often begun after the drug has already received FDA approval and is being used in the marketplace.
Clinical trials can also be used to study a new diagnostic technique, options to improve quality of life for people with a specific disease or condition, and even options that may prevent the disease.
In reading about clinical trials, you have likely seen the terms
The Risks and the Benefits
Rules and regulations have been established to protect study participants from risk as much as possible, but not all risk is avoidable because there is an element of the unknown involved in medical research. Researchers are required to give prospective study participants complete information about the planned protocol for the clinical trial. Participants are required to sign an informed consent before entering the trial that shows they realize and understand there are known and unknown risks involved, such as: There may be side effects that range from mildly unpleasant to fatal reactions; the experimental treatment may not be beneficial or effective for the study participant; and the protocol may be more rigorous than you originally thought.
There are benefits, too. Besides a willingness to help medical research, a study participant gains access to the newest treatment possibility and to medical experts. The study participant becomes involved in their health care and may be able to continue with the drug even after the study ends if they had a good response.
The Informed Consent
The FDA requires that study participants be informed about several things. When participating in a study you must be informed of the purpose of the study; whether the trial is studying an experimental drug or medical device; the time required for the entire study; what happens during the study; what the risks and benefits are; and other procedures you may wish to consider besides the treatment being studied. You'll also be informed of where to get medical help if you are hurt during the trial, your contact person should any problems arise, and the fact that you can quit at any time.
Finding Out about Trials
Many people are interested in becoming a study participant, but don't know how to start the process. Get your questions ready and then surf the Net for clinical-trial Web sites. The best ones are: ClinicalTrials. gov (
The bottom line about being a clinical trial participant: Be sure you understand all aspects of the trial you are considering, and be sure you know all of your rights as a study participant.