Women continue to be under-enrolled in cancer clinical trials, according to a new review, published in the July 15, 2009 issue of CANCER, a peer-reviewed journal of the American Cancer Society. The study's results suggest that greater efforts are needed to ensure that oncologists know the true effects of treatments and medical procedures in female patients.
In 1993, the National Institutes of Health called for clinical trials to include adequate representation of women. To define better the representation of women as subjects in the full range of high-impact, clinical cancer research published currently, Reshma Jagsi, MD, DPhil of the University of Michigan in Ann Arbor and colleagues reviewed cancer clinical research appearing in eight highly regarded journals in 2006. These journals included the New England Journal of Medicine, JAMA, the Lancet, the Journal of Clinical Oncology, the Journal of the National Cancer Institute, Lancet Oncology, Clinical Cancer Research, and CANCER. The investigators also assessed whether studies funded privately (such as by drug companies) are as likely to include female participants as those with federal funding.
The analysis reviewed 661 prospective clinical cancer studies that enrolled more than a million participants . For each of the seven non-sex-specific cancer types assessed, the majority of studies enrolled a lower proportion of women than the proportion of women with that type of cancer in the general population. Non-sex-specific cancers included hematologic (blood-related), gastrointestinal, urinary, lung, nervous system, and head and neck cancers, as well as sarcomas (connective tissue-related). On average, women constituted 38.8 percent of patients enrolled in a study.
Women made up a significantly lower proportion of studies that focused on treatment for six of the seven non-sex-specific cancer types (excluding hematologic cancers). Studies that relied on government funding had a higher percentage of female participants than those that were supported by private funds (41.3 percent vs. 36.9 percent). This suggests that government policies may encourage more balance when enrolling men and women in clinical studies. There also may be differences in review processes, grant size, or priorities associated with research funded by the government compared with those supported by industry.
According to the authors, future research should investigate why fewer women are enrolled in most cancer clinical studies. Barriers that may discourage women from research participation could include lack of information, fear, and perceived interference with personal responsibilities such as childcare. Also, some study investigators may be concerned with protecting women of childbearing age and may wish to limit their exposure to investigational medical interventions.
"Only by understanding the forces affecting the sex distribution of study subjects can we as a society succeed in ensuring that our medical research efforts are inclusive and to the benefit of all," the authors conclude.
Article: "Under-representation of women in high-impact published clinical cancer research." Reshma Jagsi, Amy R. Motomura, Sudha Amarnath, Aleksandra Jankovic, Nathan Sheets, and Peter A. Ubel. CANCER; Published Online: June 08, 2009 (DOI: 10.1002/cncr.24366); Print Issue Date: July 15, 2009.