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Shortage of Clinical Trial Participants Hinders War On Cancer

By: Jessica Langholtz; Published: August 10, 2009 @ 9:23 am | Comments Disabled

On August 2, The New York Times reported that the greatest barrier to the war on cancer is the lack of volunteers for cancer treatment studies. Although multiple myeloma was not mentioned specifically in the article, clinical trials for new drugs are significant for patients of all cancer types.

Even though considerable knowledge has emerged on the genetic origins of cancer since Richard Nixon declared war on cancer, the death rates from the disease have barely changed since his presidency in the 1970s. According to Dr. Scott Ramsey, a cancer researcher and health economist, the limited number of cancer patients volunteering for clinical trials poses as a significant obstacle in discovering cures for cancer. In fact, only three percent of all adult cancer patients participate in clinical trials for new cancer drugs or drug regimens.

According to a trials registry website, clinicaltrials.gov, there are more than 6,500 cancer clinical trials seeking adult patients. However, many will be abandoned along the way due to limited participation, with more than 20 percent of trials sponsored by the National Cancer Institute failing to enroll a single subject, and only half enrolling the minimum number needed for a meaningful result. Furthermore, many of the studies that succeed in enrolling enough patients do little to advance the research field and are unlikely to provide a significant breakthrough in cancer treatment.

These statistics indicate that most patients are not interested in clinical trials. For some, the idea of extra office visits and tests are overwhelming when they are contemplating how to save their own lives; others are afraid of receiving a placebo treatment, even though placebos are rarely used in American clinical trials.

Many oncologists also choose to steer clear of clinical trials, often because of the extra work and the potential to lose profits. Chemotherapy drugs usually provide 60 to 80 percent of revenue in oncologists’ offices. However, the federal government or the sponsoring pharmaceutical company frequently pays for the drugs of clinical trial participants, and the oncologist ends up losing money. Most trials also require voluminous paperwork and the additional risk of legal liability for failing to mention conflicts of interest.

For many oncologists, it simply does not make economic sense to enroll patients in clinical trials. Even those that try to do so, such as the California Cancer Care, end up with very minimal success. The California Cancer Care enrolled just 43 of 700 new patients last year, after offering clinical trials to every patient. Consequently, a significant percentage of clinical trials remain uncompleted and unpublished because they could not recruit enough patients. In fact, only 20 percent of clinical trials even publish results.

In response to this problem in clinical trials, cancer experts are offering two suggestions. The first is to spend more, offering doctors better incentives and perhaps even paying patients for participation. The second, and perhaps the more practical in light of limited funding, is to use available money and patients more efficiently.

Dr. Donald Berry, a statistician at the M.D. Anderson Cancer Center in Houston, designed a new study to use resources more efficiently. The study, which will start this fall, will test experimental drugs for breast cancer. The participants will be women who are newly diagnosed with breast cancer and at high risk for metastasis, or the spread of cancer.

Traditionally, breast cancer patients first undergo surgery to remove the tumor in their breast and then receive chemotherapy treatments. However, by removing the tumor right away, it is unclear if the experimental chemotherapy drug killed any remaining cancer cells. In fact, it can take up to five to 10 years before the success of the drug may be assessed. It is much easier and faster to analyze the experimental drug’s effects on tumors that remain in the body.

As a result, Dr. Berry’s study will reverse the order of the treatments. The standard chemotherapy and experimental drugs would be administered first, then the MRI scans to track progress, and if it’s still necessary after six months, surgery to remove the tumor. Since death is caused by metastasis, cancer researchers claim that surgery would not save the lives of patients in the study with such large tumors, and it actually makes no difference whether chemotherapy comes before or after surgery.

Although scientists still have yet to win the war on cancer, advocating a more efficient usage of resources is a promising change. Perhaps reinventing the traditional model of clinical trials for cancer will yield therapeutic discoveries.

For more information, please see The New York Times [1].


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[1] The New York Times: http://www.nytimes.com/2009/08/03/health/research/03trials.html?_r=1&scp=10&sq=cancer&st=cse

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