Standard-of-Care Control Groups in Breast Cancer Trials Often Not Standard, Study Says

Standard-of-Care Control Groups in Breast Cancer Trials Often Not Standard, Study Says
Many breast cancer clinical trials that are described as comparing a new treatment with a standard-of-care therapy do not actually make such a comparison, University of Sydney researchers argue. That's because they fail to follow U.S. or European clinical practice guidelines on control treatments, the team contended. The risk of doing this is generating a biased assessment of a new drug, they said. "An inappropriate comparator, such as a drug or dose that is less effective than the standard of care, may result in a new treatment appearing more effective than it really is,” Dr. Rachel F. Dear said in a press release. “Another type of inappropriate comparator may be a treatment that may not be inferior but is not provided or accepted as the standard of care, which will result in outcomes that are difficult to interpret and implement in the context of multiple standards across multiple trials," she added. She was the lead author of the team's article in the Journal of the NCCN titled “‘Standard Care’ in Cancer Clinical Trials: An Analysis of Care Provided to Women in the Control Arms of Breast Cancer Clinical Trials.” To examine how those conducting clinical trials defined standard of care, the team looked at 210 trials that recruited 229,182 women worldwide. They compared the trials' standard of care or control treatments with what U.S. and German guidelines call for. The U.S. standards are in the National Comprehensive Cancer Network (NC
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One comment

  1. Wanda Northam, MD says:

    In the day of MIS, data mining should be used to provide control groups for Triple Negative Breast Cancer and other cancers with poor or dismal prognoses and perhaps as well with metastatic breast cancers which we have long histories available of their morbidities/outcomes. It is high time research protocols enter the computer age.

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