Cancer Clinical Trials

By Ellen Stovall
President & CEO of the National Coalition for Cancer Survivorship

Stovall appeared before the House Committee on Government Reform on May 13, 2004 regarding cancer clinical trials. Below is an edited portion of her statement.

There are many reasons why the rate of participation in cancer clinical trials is much lower than we would wish. Both physicians who enroll their patients in clinical trials and those individuals who agree to receive their care in a clinical trial may encounter barriers to participation. All of those obstacles must be addressed if we are to improve the clinical trials system.

The cancer community has made great strides in increasing the awareness that care in a clinical trial may be the best treatment option for a cancer patient, but our educational mission is not complete. We still have to address the fears of some regarding the risks associated with clinical trials, as well as the reservations of others about the value of trials. This is perhaps most acutely felt in underserved communities where socioeconomic, cultural, ethnic and language differences present even more barriers to participation. Cancer patients may have to make sacrifices to enroll in a trial, and they want to believe that their time and energy are well spent in a valuable research endeavor.

For more than a decade, NCCS and other patient advocacy organizations and the American Society of Clinical Oncology collaborated in a legislative effort to address the failure by third-party payers to pay for routine patient care costs in trials. After many years of unsuccessful legislative effort, we were able to persuade the Clinton Administration to issue an executive memorandum instructing the Medicare program to allow all beneficiaries, those with cancer and other diseases, to participate in high-quality clinical trials. With this change, and the leadership role of Medicare in health policy, reimbursement has seemingly become less of an obstacle than before.

While cost is a primary concern, of no less concern is the fact that so few doctors recommend a clinical trial as a viable treatment option. Clinical research is expensive, requiring an extensive infrastructure, both at the central points of control and at the level of the individual provider. For many years, cancer clinical researchers have made clear that the rate of payment from the National Cancer Institute (NCI) for their participation in clinical trials is inadequate, despite some modest increases by NCI. Privately funded research has overtaken that sponsored by the National Institutes of Health and other federal sources because industry is willing and able to pay the full cost of research, whereas the government’s funding lags behind.

Over the last two decades, cancer care has truly moved to the community. This system of care has been welcomed by cancer patients, who prefer to receive their care near their homes, thereby avoiding the dislocations that occur if they must travel.

We are hearing disturbing reports from community oncologists that, as the result of changes in Medicare reimbursement for cancer care that were included in the Medicare Modernization Act, or MMA, they may be forced to reassess their participation in clinical trials.

The concern of all of us who care about quality cancer care is that, in 2005, the MMA will reduce total payments for cancer care to such an extent that services offered by the community oncologist will have to be reduced, and clinical trial participation may be among the first services to go.

Our country is unusual in our ability to provide high-quality care in the local community. However, the system is suffering many strains. No strain is greater than that created by the system of payment for cancer care. The inadequate NCI payment for enrolling a patient in a trial, the payment reforms included in MMA, the occasional denial of third-party payment for care in a clinical trial—all of these factors are creating stress in a system that should be protected and nurtured.

NCCS and others have been engaged for more than a decade in efforts that will ensure clinical trials are an integral part of cancer care in this country. We are dedicated to continuing that fight.