Participating in a clinical trial

Questions you may have

What are the benefits and risks of participating in a clinical trial?
Can I stop participating in a clinical trial once I start?
Will I be paid to participate?
Will participating in a clinical trial cost me money?

Clinical trials are research studies that involve people. These studies test new ways to prevent, detect, diagnose, or treat diseases. People who take part in cancer clinical trials have an opportunity to contribute to scientists' knowledge about cancer and to potentially help in the development of improved cancer treatments. (1)

Once you find a trial you're interested in:

  • Talk to your doctor. Your doctor might be familiar with the drug or therapy involved in the trial. Your doctor can discuss with you the benefits and risks of the clinical trial and whether you might be eligible to participate.
  • Contact the clinical trial coordinator. This person is often listed with the clinical trial announcement. You or your doctor can talk with the study coordinator about your health and whether you meet the criteria for the study.
  • Schedule a pretrial screening. At the screening, you'll undergo various tests to determine whether you qualify for the clinical trial. You'll also get a chance to talk to the investigators about what the trial involves, as well as its risks and benefits. (2)

What are the benefits and risks of participating in a clinical trial?

The benefits of participating in a clinical trial include the following:

  • Trial participants have access to promising new interventions that are generally not available outside of a clinical trial.
  • The intervention being studied may be more effective than standard therapy. If it is more effective, trial participants may be the first to benefit from it.
  • Trial participants receive regular and careful medical attention from a research team that includes doctors, nurses, and other health professionals.
  • The results of the trial may help other people who need cancer treatment in the future.
  • Trial participants are helping scientists learn more about cancer (e.g., how it grows, how it acts, and what influences its growth and spread). (1)

The potential risks of participating in a clinical trial include the following:

  • The new intervention being studied may not be better than standard therapy, or it may have harmful side effects that doctors do not expect or that are worse than those associated with standard therapy.
  • Trial participants may be required to make more visits to the doctor than they would if they were not in a clinical trial and/or may need to travel farther for those visits.
  • Health insurance may not cover all patient care costs in a trial. (1)

Can I stop participating in a clinical trial once I start?

All patients in clinical trials are volunteers. You can choose to quit a clinical trial at any time, but talk to your doctor first. Your doctor can tell you how quitting the trial might affect your health and if there are other treatment options. Your relationship with your health care providers will not be changed by your decision. (4)

Will I be paid to participate?

Seattle Genetics does not pay subjects for participating in research.

Any possible costs to subjects who participate in a study are discussed with potential participants during the informed consent process, and documented in the informed consent form.

Will participating in a clinical trial cost me money?

The costs of care for people participating in a clinical trial fall into two general categories: 1) routine care costs, and 2) research costs.

Routine care costs are costs associated with treating a person's cancer whether or not they are in a trial. These costs are usually covered by health insurance, but requirements vary by state and type of health plan.

Research costs are costs associated with conducting a clinical trial; these costs may include the costs of extra doctor visits, extra tests, and procedures that are required for the trial but would not be part of routine care. Research costs are usually covered by the organization that sponsors the trial.

It is important to investigate how the costs of care will be covered before joining a clinical trial. Many states require that insurance companies operating in those states cover routine care costs; in other states, voluntary agreements between the states and insurance companies include such a provision. In states without these requirements or agreements, health plans may not cover routine care costs for people taking part in cancer treatment trials if the interventions being tested are considered experimental or investigational. States also vary in their requirements for covering costs associated with participation in cancer screening and prevention trials. Anyone thinking about taking part in a clinical trial should discuss cost coverage issues with representatives of their health plan. In some cases, it helps to have someone from the research team talk with the health plan's representatives.

State laws and voluntary agreements, and health plans in states without laws or agreements, may list certain criteria that a trial must meet before routine care costs can be covered. For example: 1) the trial must be conducted or approved by specific organizations; 2) there must be a "reasonable expectation" that the treatment being tested in the trial will be at least as effective as the current standard of care; 3) the costs of treatments in the trial must not be substantially higher than the costs of treatments that are usually considered standard; and 4) the trial must focus on a type of cancer for which no standard treatment is available. In addition, the hospital or treatment facility and its medical staff may have to meet a health plan's qualifications for performing certain specialty procedures, such as bone marrow transplants, if they are required as part of the trial. (1)

Some federal programs help pay the costs of care in clinical trials:

  • Medicare reimburses patient care costs for its beneficiaries who participate in clinical trials designed to diagnose or treat cancer. Information about Medicare coverage of clinical trials is available online or by calling Medicare's toll-free number for beneficiaries at 1-800-633-4227 (1-800-MEDICARE). The toll-free number for the hearing impaired is 1-877-486-2048.
  • Beneficiaries of TRICARE, the Department of Defense's health program, can be reimbursed for the medical costs of participating in NCI-sponsored phase II and phase III cancer treatment and cancer prevention (includes screening and early detection) trials.
  • The Department of Veterans Affairs (VA) allows eligible veterans to participate in NCI-sponsored prevention, diagnosis, and treatment studies nationwide. All phases and types of NCI-sponsored trials are included. Visit TRICARE Cancer Clinical Trials for more information about this benefit. (1)

References

  1. "Cancer Clinical Trials." National cancer institute, National Institutes of Health [learn more]
  2. "Clinical Trials, A chance to try new therapies." Mayo Clinic. The Mayo Clinic, 02 Jul 2011. Web. 10 Aug 2012. [learn more]
  3. National Cancer Institute, "Clinical trials take place in phases." Taking part in cancer treatment research studies. National Institutes of Health, 2007. Web. 10 Aug 2012. [learn more]
  4. "Joining A Clinical Trial. "MD Anderson Cancer Center. MD Anderson, n.d. Web. 10 Aug 2012. [learn more]

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