Background
How much money does NCI spend on clinical trials and what do these funds pay for?
What costs are the responsibility of the patient and his/her health plan?
Is it more expensive to participate in a trial than to receive standard treatment?

Background

NCI's investment in cancer clinical trials is an investment in the future, one that promises not only to benefit individuals with cancer but also the society at large by reducing the financial burden exacted by the disease. Studies have demonstrated that the financial costs incurred by individuals who have chosen to participate in clinical trials have proved an impediment to some people who might otherwise have elected to enroll; in particular, older patients. Recognizing the value of the benefits that accrue to individuals and society as a result of robust clinical trial participation, the federal government and many states have enacted measures mandating insurance coverage for clinical trial participants.

How much money does NCI spend on clinical trials and what do these funds pay for?

In fiscal year 2004, the NCI spent approximately 800 million dollars on clinical trials.⁹ NCI funding helps pay for some of the costs associated with clinical trials, including:

• developing research concepts,
• preparing and reviewing trial protocols,
• monitoring patient safety,
• collecting and analyzing data,
• ensuring data accuracy, and
• manufacturing and distributing experimental drugs.

What costs are the responsibility of the patient or his/her health plan?

For participants in NCI-supported extramural trials, the Institute provides experimental drugs at no cost. Routine patient care costs associated with participation in an extramural trial, however, are paid for either by the patient or by his or her health plan. Patient care costs can include, for example, laboratory tests, office visits, and the administration of standard cancer-related drugs. Health plans are expected to cover drugs that are not experimental. These may include supportive medicines, such as antinausea drugs.

In 2000, Congress mandated a change in Medicare policy to require the coverage of routine patient care costs for clinical trial participants; evidence indicates that this change may have led to increased clinical trial participation by older patients who have Medicare coverage combined with supplemental private insurance coverage.¹⁰ For more information on reimbursement for medical costs associated with clinical trials, see Medicare Coverage of Clinical Trials and Private Insurers' Coverage of Clinical Trials.

Some states have passed legislation or instituted special agreements that require health plans to pay the cost of routine medical care that patients incur while participating in certain clinical trials. For more information on the specific provisions passed by individual states, see States That Require Health Plans to Cover Patient Care Costs in Clinical Trials.

There is no charge for medical care received at the NIH Clinical Center in Bethesda, Maryland, for patients participating in intramural trials. Patients are responsible for travel costs for their initial screening visits. In most cases, once patients are enrolled in a study, the NCI will pay for the transportation costs for all study-related visits for patients who do not live in the local area. In addition, these patients will receive a small per diem for food and lodging expenses if they are being treated as outpatients.

Pediatric patients and family members can stay at the Children's Inn, which is located on the NIH campus close to the Clinical Center, at no charge, provided eligibility criteria are met. Family members and other loved ones of adult patients enrolled in clinical trials taking place at the NIH Clinical Center are also eligible to stay at the Edmond J. Safra Family Lodge at no charge. The Family Lodge, also located on the NIH campus, opened in May 2005; a complete list of its amenities and eligibility criteria is available on its Web site.

Is it more expensive to participate in a trial than to receive standard treatment?

Several studies have found that the costs of caring for patients enrolled in clinical trials are not substantially greater than the costs of standard care.^11-14 Additional larger studies exploring this issue are in progress.

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