Clinical Trials: What Do You Need to Know?
Clinical trials are research studies in which people help doctors find ways to improve health and care. Studies try to answer scientific questions, and to find better ways to prevent, diagnose or treat disease. Anyone who has participated in a clinical trial that tests a medication or other treatment knows that the protocol is highly regulated.A clinical trial is a test, in humans, of an experimental treatment. Although it's possible that benefit may be derived from participating in a clinical trial, it's also possible that no benefit — or even harm — may occur. Therefore, the decision about whether to participate in a clinical trial requires careful consideration. Keep your MDA clinic doctor informed about your clinical trial participation.
A clinical trial is one of the final stages of a long and careful research process. Studies are done to find out whether promising approaches to prevention, diagnosis and treatment are safe and effective.
The different types of clinical trials are:
- Treatment trials
- Prevention trials
- Screening trials
- Quality-of-life trials.
- Phase 1 trials. These first studies in people evaluate how a new drug should be given (by mouth, injected into the blood or injected into the muscle), how often it’s given and what dose is safe. A phase 1 trial usually enrolls only a small number of patients, sometimes as few as a dozen.
- Phase 2 trials. A phase 2 trial continues to test the safety of the drug and begins to evaluate how well the new drug works.
- Phase 3 trials. These studies test a new drug, a new combination of drugs or a new surgical procedure for comparison to the current standard. A participant will usually be assigned to the standard group or the new group through a process called randomization, which helps ensure an unbiased result. Phase 3 trials often enroll large numbers of people, and may be conducted at many doctors' offices, clinics and centers nationwide.
- Phase 4 trials. After a treatment has been approved and is on the market, the drug company may study it further in a phase 4 trial. The purpose of phase 4 trials is to evaluate the side effects, risks and benefits of a drug over a longer period of time and in a larger number of people than in phase 3 clinical trials. Thousands of people are often involved in a phase 4 trial.
Informed consent is the principal tool through which adults participating in clinical trials are asked to weigh potential risks and benefits. (Parents provide consent for children in trials, although the FDA recommends that children as young as 7 be asked to agree to participation when feasible.)
The FDA, through local institutional review boards (IRBs), oversees informed consent documents and requires that prospective trial participants be told that the study involves an unproven drug or treatment. Participants also must be told what will happen in the study and how long it will last, and that they can leave the study at any time without penalty. Furthermore, study participants must be made aware of any possible risks, discomforts or benefits.
Anyone who is interested in participating in a clinical trial should feel free to ask any questions or bring up any issues concerning the trial at any time. When deciding on participation in a clinical trial, you may wish to consider the following:
- What is the trial designed to do?
- What will I/my child be asked to do each visit? Between visits? Each day?
- Can we adhere to the requirements of the trial for the duration?
- What is the duration of the trial?
- Will we get feedback during or after the trial? What will that include?
- Are our expectations of the trial realistic?
- What costs are associated with the trial participation (time, travel, money, etc.)?
- Does participating in this trial preclude us from participating in anything else during or after this trial?
The following suggestions from the National Institutes of Health (NIH) may give you some additional ideas as you think about your own questions.
Possible risks and benefits
- What are my possible short-term benefits?
- What are my possible long-term benefits?
- What are my short-term risks, such as side effects?
- What are my possible long-term risks?
- What kinds of therapies, procedures and/or tests will I have during the trial?
- Will they hurt, and if so, for how long?
- How do the tests in the study compare with those I would have outside of the trial?
- Will I be able to take my regular medications while in the clinical trial?
- Where will I receive my medical care?
- Who will be in charge of my care?
- How could being in this study affect my daily life?
- Can I talk to other people in the study?
- Will I have to pay for any part of the trial, such as tests or the study drug? If so, what will the charges likely be?
- What is my health insurance likely to cover?
- Who can help answer any questions from my insurance company or health plan?
- Will there be any travel or child care costs that I need to consider while I am in the trial?
Consider taking a family member or friend for support, and to help you when asking questions. Make a list of questions prior to meeting with your physician, but don't hesitate to ask any new questions that come up during the appointment. And, it also will help to write down the answers, so you can review them whenever you want.
No comments:
Post a Comment
Please feel free to comment. By taking a moment to share your thoughts you add much to these articles. The articles then become more than just something I said or believe. In addition, by adding a comment, you might just be helping the next reader by sharing your opinion, experience, or a helpful tip. You can comment below or by sending me an email. I look forward to hearing from you.