Clinical Trial Cost Considerations

Participation in a clinical trial is generally free of charge. Generally the sponsor of the trial pays for the actual drug and special tests required by a clinical trial. However, there may be costs associated with a trial that may or may not be fully covered by the trial sponsor and /or research institution. Which expenses are covered varies among trials. Discuss this issue with the trial sponsor and your doctor.

Patient care costs associated with a clinical trial fall into two main categories: Usual Care Costs and Extra Care Costs.

• Usual care costs:  Are those that are traditionally covered by a health plan such as private insurance or Medicare. These may include doctor visits, hospitalizations, lab tests such as blood tests, and x-rays, or other services that are typically provided when receiving standard treatment or participating in a clinical trial. Usual care costs are usually covered by health plans. 
• Extra care costs:  Are those costs that directly relate to participation in a clinical trial. For example, extra care costs include additional tests that may be required to monitor your progress. The provider of the trial may not always cover these extra expenses. In such cases, the trial sponsor and your health plan need to resolve these coverages.Extra care costs may not be covered. 
• The question comes down to your particular coverage, and the specific trial and costs in question.

If the trial in which you are interested is being conducted at more than one site near you, check to see which site covers more of your costs. Some sites may even provide money for transportation, food or child care. If it appears that significant costs will not be covered, see: How To Get Your Insurance Company To Say Yes To Paying The Costs Of A Clinical Trial.

Help with costs associated with clinical trials is provided by several organizations including the national Children's Cancer Society (www.childrenscancer.org ). Mercy Medical Airlift (www.mercymedical.org ) and Angel Flight America (www.angelflightamerica.org ) can help with travel arrangements. 

When thinking about your costs for entering a trial: If you have to travel to get to the trial, include the cost of transportation. If you have to stay over in a different location, include the cost of lodging and meals.

For information with respect to different types of health insurance, see:

• Medicare  
• Medicaid  
• Private Health Insurance Coverage  

NOTE: Over the last few years a number of insurance companies have begun to change their policies with respect to coverage of clinical trials. Some government employees are now covered for clinical trials (Department of Defense), as well as those individuals covered under the Department of Veterans Affairs.  Many insurance companies are now paying for trial associated costs, or are willing to make a determination on a case-by-case basis.

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