December 2001
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A Word to the Wise Questions to ask when you're considering taking part in a clinical trial About the research:
About your participation in the study:
About risks and benefits:
Other questions:
Source: ClinicalTrials.gov |
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Who to Contact For more information on NIH clinical trials, go to http://clinicaltrials.gov. The database there includes over 5,000 clinical studies sponsored by the NIH and other Federal agencies. The site also provides important background information for patients, families and anyone considering participating in a research study. For information about enrolling as a patient in a clinical trial at the NIH Clinical Center, please visit http://www.cc.nih.gov/ccc/prpl or call the Patient Recruitment and Public Liaison Office at 1-800-411-1222. For information about Medicare benefits, call Medicare's toll-free number, 1-800-MEDICARE (1-800-633-4227) 24 hours a day, seven days a week. If you have a hearing or speech impairment, call the TTY/TDD line toll-free at 1-877-486-2048. The official U.S. Government website for Medicare at http://www.medicare.gov includes general information and information on enrollment. For publications on Medicare, including "Medicare and Clinical Trials" (#02226-S), click on "Publications"on the left side of the screen. For more in-depth information on Medicare coverage, go to: http:www.hcfa.gov/coverage/8d.htm. Medicare does not have the authority to pre-authorize or pre-certify that a trial will be covered. |
Medicare Insurance Covers Clinical Trials
Another Reason to Participate
Are you over 65 and thinking about participating in a clinical trial? If so, there's an important change in your health insurance you should know about. Your Medicare health insurance will now cover many of the routine costs of clinical trials.
Very few older Americans currently participate in clinical trials even though they are more likely than younger people to have a disease or chronic illness that scientists are studying. Many have been concerned about the additional costs they might incur. Some fear they may even lose their Medicare coverage.
Medicare, managed by the Centers for Medicare and Medicaid Services (formerly the Health Care Financing Administration, or HCFA), is the nation's largest health insurance program, covering more than 40 million Americans. Most people in the program are over the age of 65.
Why Participate?
Clinical trials are designed to improve medical care by testing the safety and effectiveness of new drugs and treatments, or by finding new ways to use treatments that doctors are already prescribing for another condition. A clinical trial is one of the final steps in a long and thorough research process that often takes years to complete.
Many people consider participating in a clinical trial only after standard treatments for their diseases have failed, but there are other reasons to participate. If you are older and have a chronic illness, enrolling in a clinical trial could give you access to high-quality health care from physicians who are experts in their field. You also may benefit from new and potentially better treatments that are not yet widely available.
When you participate in a clinical trial, you are helping the research team find new ways to improve present and future health care.
Getting In
How do you find an appropriate clinical trial? Your health care provider may have heard of one you might qualify for and recommend that you look into it. Many research institutions also actively recruit people for new clinical trials. Studies recruiting patients at the NIH Clinical Center in Bethesda, Maryland, for example, can be found at http://www.cc.nih.gov/ccc/prpl.
NIH, in collaboration with the Food and Drug Administration (FDA), has set up a web site at http://clinicaltrials.govthat lists clinical studies sponsored primarily by NIH and other Federal agencies. Studies from the pharmaceutical industry are also slated to be included during the coming year.
All clinical trials have guidelines about who will be selected to participate. These guidelines are based on factors such as age, type of disease, medical history and current medical condition. Guidelines are designed to keep participants safe and to find people who will help the researchers answer the specific questions they plan to study. If you don't get into a study, remember that it isn't personal.
And if you get into a study, remember that you have the right to quit at any time.
New Medicare Rules
If you're covered by Medicare, find out if the clinical trial you're considering is a qualifying clinical trial. In general, studies sponsored by NIH qualify under the new rules. (To qualify, the study must evaluate a treatment or intervention that is normally covered by Medicare; be designed to treat or diagnose a health problem or condition; and enroll patients with the disease under investigation, rather than healthy volunteers).
If you have questions about whether your trial is covered, contact Medicare for more information (see side box).
Under the new Medicare rules, routine tests, procedures, and office visits that are needed during a qualifying trial are now covered. If you develop any complications as a result of your participation, Medicare also will cover medically necessary health care you may need. Some items and services are not reimbursed, including the cost of experimental drugs or devices that are being tested. But these are likely already provided free of charge through the study itself. Talk to the trial's representatives about exactly which services and items will be provided in their study.
Finally, it's important to keep up-to-date with your Medicare coverage because more changes may occur as the new rules are put into effect over time. Getting more information about your health insurance can help you decide if participating in a clinical trial is right for you.
— a report from The NIH Word on Health, December 2001
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