- Who Can Participate
- What You Need to Know
- Find Out How the Study is Controlled
- Understand Informed Consent
- Coordinate Your Medical Care
- Know What Costs are Covered
- Glossary of Clinical Trial Terms
- Additional Clinical Trial Resources
Who Can Participate
People who wish to enroll in clinical trials often must meet the following requirements. Each study also will have its own additional requirements:
- The patient should reside close to the research facility (usually within 150 miles).
- The patient usually must have a specific diagnosis.
- The patient must meet the study guidelines relating to age, sex, level of disability, and duration of disease.
- The patient usually must be able to understand the possible risks of participating, give consent, and be able and willing to follow study instructions.
What You Need to Know
If you are thinking about participating in a clinical trial, here are some key questions to ask before making a decision:
- What is the purpose of the study?
- Why do researchers believe this new treatment being tested might be effective? Has it been tested before?
- What kinds of tests and treatments are involved?
- How often will I have to come to the study site?
- How do the possible risks, side effects, and benefits in the study compare with my current treatment?
- How might this trial affect my daily life?
- How long will the trial last?
- Who will pay for the experimental treatment?
- Will I be reimbursed for other expenses?
- What type of long-term, follow-up care is involved with this study?
- How will I know if the experimental treatment is working? Will results of the trials be provided to me?
- What is the probability that I will receive an inactive placebo?
Find Out How the Study is Controlled
Well-designed clinical trials should be “controlled” to minimize the amount of bias that enters into the results. Many times the controls involve a certain proportion of the participants receiving the treatment being tested and the other participants receiving a previously-approved treatment or an inactive placebo. However, the use of an inactive placebo in MS studies has become an issue of ethical concern, now that there are multiple, partially effective therapies to treat relapsing forms of MS.
If you are considering becoming involved in a study in which the experimental drug is being compared to an inactive placebo, make sure that you understand your treatment options with therapies already on the market, and that you know what the probability is that you will receive the inactive placebo. Read more about the ethics of placebo-controlled trials.
Understand Informed Consent
Before you agree to participate, you will be asked to understand and sign an “informed consent” form. The form should provide a summary of the clinical trial, including its purpose, the treatment procedures and schedule, potential risks and benefits, and alternatives to participation. Informed consent is not just a document. It’s a process that involves discussing the form before you enter the study, getting updates throughout the study, and knowing that you can ask questions of the research team at any time before, during, or after the study. You also can decide to leave a clinical trial at any time—just let the research team know your reasons for leaving the study.
Coordinate Your Medical Care
Before participating in a clinical trial, discuss the study with your doctor. If you decide to participate, put your doctor in touch with the doctor running the study. Give your doctor permission to share medical information. That will help ensure your safety during a clinical trial. Be sure to tell the doctor and coordinator running the study if you need to receive routine care for a medical condition other than the one being treated in the clinical trial. Even a routine treatment for an unrelated condition might interact with the study drug during a clinical trial.
Know What Costs are Covered
Understand who is covering the costs of the study. The informed consent form should outline any costs that will be billed to you. In most cases, the research team covers the cost of the study drug and any medical care performed to fulfill the study goals. Contact your health insurer—with the protocol or informed consent form in hand—to find out whether treatment for any side effects or routine care will be covered so that you understand fully what you might be expected to pay.
Some terms commonly used related to clinical studies.
More listings of ongoing MS studies and general information on participation in clinical research.