Assessment of gender representation in clinical trials leading to FDA approval for oncology therapeutics between 2014 and 2019: A systematic review-based cohort study
- Gender representation in oncology clinical trials varies by cancer type, with women often underrepresented compared to national cancer incidence.
- Despite FDA guidelines from June 2015 requiring consideration of biological variables like sex in research designs, disparities persist.
- Women continue to be underrepresented in clinical trials, despite being major consumers of healthcare and primary decision-makers in health contexts.
- Specific cancer types like thyroid cancer show male over representation, while soft tissue malignancies show female over representation.
- Factors contributing to gender discrepancies may include trial criteria, burdens like travel and expenses, and potentially decreased willingness to participate.
- Studies exclude criteria such as industry funding, performance status, and mortality, focusing on incidence to represent trial demographics.
- Addressing gender disparities is crucial, especially with increasing cancer cases and clinical trials. Ensuring trial results are applicable to all genders is a primary goal.
- Further efforts are needed to make clinical trials more generalizable, including best practice recommendations, gender-specific guidance, and enhanced analysis and reporting by gender.
Gender disparities in health care have influenced processes for appropriate diagnoses and treatment of many health conditions. Among patients with cancer, these epidemiological variations have driven advancements to alleviate gender-specific differences in cancer susceptibility and mortality. Clinical trials are essential for the development of novel cancer drug treatments and can benefit the medical community. As a result of the evidence that women were underrepresented in important clinical trials, in 1993, the US National Institutes of Health (NIH) issued the Revitalization Act: a guideline for the evaluation of gender and minority differences in clinical trials for the full range of patients using the therapy.
In 2016, the European Association of Science Editors published the influential Sex and Gender Equity in Research guidelines to integrate sex and gender reporting into articles. Currently, cancer clinical trials incorporate sex differences for a better understanding of the efficacy and toxicity of chemotherapeutics, as well as the roles of genetics and sex hormones. However, trial populations may not always represent the population that they are trying to emulate. It has been shown in several studies, in both oncology and nononcology clinical trial settings, that women may be underrepresented in clinical trials...
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