Sex and Gender disparities in clinical research
We have looked previously at the importance of recruiting a patient group that is racially and ethnically diverse, but it is equally vital to consider sex and gender differences in the patient recruitment process. There is a clear sex-gender disparity in the occurrence and treatment outcomes of certain diseases, and this can be dangerous to the reproducibility and generalizability of trial results.
For the purposes of medical research, a distinction must be made between sex (that which is biologically different between male, female, and intersex bodies at birth) and gender (one’s identity as influenced by psycho-social, cultural and environmental factors.)
While recent years have brought forth a push for more inclusive sex-gender clinical protocol, the enrollment process for some medical trials is still lacking. Most notably, a 2020 study examining cancer trials for sex and gender disparity found that females were underrepresented in preclinical and early phase clinical trials.
This is particularly concerning given the evidence for sex differences in medicine. For instance, a significant body of research has found that female bodies are more likely to experience gastrointestinal toxicity, and that female cancer patients can receive comparatively fewer cycles of chemotherapy than males.
Gender disparities are also prominent in cancer research, particularly in transgender men and women. Gender identity is not routinely collected during a clinical trial, so data regarding the exact risks of these groups is limited. There is potential for cancer risk associated with the use of sex hormones, as well as largely unstudied risk for reproductive cancers in transgender men and women who have undergone sex reassignment surgery.
Given the growing body of research on the treatment and prevention of Covid-19, there are also concerns about the exclusion of sex and gender considerations among these studies. Several factors come into play when improving the diversity of your clinical research, including increasing education and awareness about clinical trials, as well as encouraging trust in the process through open communication. You can read more about these techniques here.
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Citrus is a fully integrated recruitment and retention software that fits any clinical trial and simplifies the implementation of patient engagement in your clinical trial. Whether you are already working with CTMS systems or not, Citrus is the perfect add-on to make patient interaction effective.
Since 2015, our team has been hard at work raising awareness of clinical trials across the globe. A Forbes ‘30 Under 30’ company and a graduate of the renowned Techstar program in New York, Citruslabs is at the forefront of patient recruitment and retention technologies. With over 3 million patients now recorded on our databases, our patient recruitment dashboard is fast becoming the most efficient method of trial recruitment.
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With more than 200 research sites now using the Citrus platform to screen thousands of patients every month, researchers are now well on their way to finding new treatments for hundreds of different health conditions - something that just would not be possible without a technological solution. Make sure that your clinical trial is in the lucky 12% and turn that luck into guaranteed results with Citrus.
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