NEW YORK, Sep 22 (Reuters Health) -- Because only 3% of breast cancer patients participate in clinical trials in the United States -- compared with rates as high as 70% for breast cancer patients in Scandinavia, and 50% of US children with cancer -- research efforts here have been hampered, according to an expert panel.
Patients fail to enroll in trials of new treatments because their doctors fail to discuss them, because participation is too time consuming for doctors, and because both sides are misinformed about trials, according to Dr. Robert Comis, director of the Eastern Cooperative Oncology Group, a consortium of cancer centers that share their data.
For example, both patients and doctors may fear randomization, even though cancer patients are assigned either to the best standard therapy or to promising new therapies -- never to (an inactive) placebo. Randomization, where patients are randomly assigned to different treatments, allows researchers to more accurately study the effects of the treatments.
"People don't go to the doctor to hear, 'I don't know which is better, so we'll have to flip a coin,'" Comis said. But he added, "This business of needing randomization is going to be with us for awhile. So it's a real educational problem."
Because not enough patients enroll in trials, important research questions have often gone unanswered, said Dr. Lisa A. Newman, a breast cancer surgeon at the University of Texas M.D. Anderson Cancer Center.
She cited a recent prevention trial using tamoxifen. African-American women are known to have estrogen receptor-negative tumors more often than Caucasians, and to develop the disease at a younger age. But tamoxifen is most effective in estrogen receptor-positive disease, yet is also safer in younger women. Because the trial had so few African-American participants, there is insufficient data to know whether tamoxifen prevents cancer in black women or not, Newman said.
To better understand the barriers to participation and to fund remedies, the Susan G. Komen Breast Cancer Foundation of Dallas, an independent provider of research support, launched a pilot project in April called CRAFT (Clinical Research: Affiliates Funding Trials). The foundation will spend more than $1 million with the hope of raising participation rates to15% to 20% of patients, said Susan Braun, president and chief executive officer.
The experts were unanimous about the need to increase patient participation in all kinds of cancer trials. "Everything we can tell patients today is based on the results of clinical trials that have been done in the past," noted Dr. Nancy Davidson, director of the breast cancer program at Johns Hopkins in Baltimore, Maryland.
