Too Few Cancer Patients Participate in Clinical Trials, Delaying Advances in Treatment (dateline May 30, 2000)
A survey of 6,000 cancer patients presented at the recent annual meeting of the American Society of Clinical Oncology (ASCO) shows that only 2% to 3% of adult cancer patients participate in clinical trials . Comparatively, 60% to 70% of children with cancer are enrolled in clinical trials. A cancer clinical trial compares a new method of treatment (a new breast cancer drug, for example) to a standard one to determine whether the new treatment is safe and effective. Many breast cancer patients, especially those with Stage IV (advanced) breast cancer, are eligible to participate in clinical trials.
Researchers cited a number of reasons why adult cancer patients do not enroll in clinical trials. Of the 6,000 patients surveyed, 84% said they were unaware of the trials or unsure that they would qualify for participation in a trial. Other reasons for low participation included the concern about medical costs, fear that treatment would not be adequate, and the concern of traveling long distances for treatment.
The media attention given to clinical trials that do not show positive results also discourages some patients from enrolling in clinical trials. For example, the less than favorable results of four small trials on high-dose chemotherapy followed by bone marrow transplants for advanced breast cancer patients earlier this year has contributed to lower patient enrollment in similar trials even though researchers believe the therapy may be beneficial for certain women with breast cancer.
Researchers say the low rate of enrollment in clinical trials slows down research and delays medical advancement. Only 4% of the 6,000 cancer patients surveyed said that they had participated in clinical trials, and the majority of those patients said they found out about the opportunities through their physicians. Previously, the American Cancer Society and the National Cancer Institute have estimated that approximately 5% of American cancer patients are enrolled in clinical trials.
Of those patients who did participate in clinical trials, almost all of them said that they were treated with “dignity and respect” and felt as though they received excellent medical treatment. Most said they would recommend clinical trials to others. An Australian study reported at the ASCO meeting found that cancer patients who participate in clinical trials can live significantly longer than patients who are not involved in research because cancer recurrence is usually detected and treated earlier in patients enrolled in trials.
Another study presented at the ASCO meeting found that the cost of taking part in cancer clinical trials is similar to the amount required for standard cancer care, at least for Phase II clinical trials . The ASCO and several patient advocacy organizations have been lobbying Congress and health care insurers to provide coverage to cancer patients who participate in clinical trials. Approximately 86% of patients in the study said their insurance carriers covered the cost of enrolling in a trial. Many clinical trials will reimburse patients for medical and transportation costs.
Researchers at the ASCO meeting urged physicians to alert cancer patients to clinical trial opportunities. Physicians can often help ease patient concerns about the cost or quality of care of trials.
Many of the cancer patients who responded to the survey said they would not enroll in a clinical trial because they were afraid of receiving a placebo (inactive treatment) instead of the treatment being tested. According to Ellen Stovall, executive director of the National Coalition for Cancer Survivorship, this fear illustrates the misconception about clinical trials. The majority of cancer trials compare a new method of treatment to a one that is currently being used.
However, some clinical trials do compare a new cancer treatment to a placebo. For example, the first breast cancer prevention trial conducted by the National Surgical Adjuvant Breast and Bowel Project (NSABP) compared the drug tamoxifen to a placebo to determine whether tamoxifen could effectively prevent breast cancer in high risk women. The trial revealed a 49% decrease in the incidence of invasive breast cancer in women who were given tamoxifen in the study.
A second trial by the NSABP (called the STAR trial ) is currently underway that will compare the effectiveness of tamoxifen with raloxifene, a promising new drug that may help prevent breast cancer in women over age 35 who are at high risk for breast cancer. The STAR trial is still recruiting participants across the United States and Canada. Click here for more information on eligibility requirements and how to enroll in the STAR clinical trial.
- The May 22, 2000 WebMD report by Robert Friedman, “Lack of Patients in Cancer Studies Hurting Treatment Advances,” is available at http://my.webmd.com/content/article/1728.57758
- The May 22, 2000 Reuters Health report by Alicia Ault, “Many Cancer Patients Unaware of Clinical Trials,” is available at http://www.reutershealth.com/archive/2000/05/22/eline/links/20000522elin036.asp
- The May 22, 2000 Reuters Health report by Alicia Ault, “Cancer Trial Cost Similar to Standard Care Costs,” is available at http://www.reutershealth.com/archive/2000/05/22/eline/links/20000522elin027.asp
- Abstracts from studies presented at the annual meeting of the American Society of Clinical Oncology (ASCO) from May 20-23, 2000 are available at http://www.asco.org/
- To learn more about clinical trials, please visit http://www.imaginis.com/breasthealth/clinical_trials.asp
- Cancer patients may search for clinical trials on the Centerwatch website at http://www.centerwatch.com/, on the National Cancer Institute website at http://cancertrials.nci.nih.gov/, and on a site developed by the National Library of Medicine at http://clinicaltrials.gov/
- The National Cancer Institute report, “Don’t Write Off High-Dose Chemotherapy for Breast Cancer, Experts Say,” is available at http://cancertrials.nci.nih.gov/types/breast/treatment/transplant/index.asp