The evidence base of medicine may be fundamentally flawed because of an ongoing failure of research to include gender differences in study design and analysis, according to an article published in the Journal of the Royal Society of Medicine.
“Historically, women have been excluded for safety reasons from clinical trials, but this prohibition has seen an enormous waste of research money and a neglect of gender research,” said Dr Holdcroft.
“Women may have a different drug efficacy or side-effect profile to men. Only recently it was reported that eight out of 10 prescription drugs were withdrawn from the US market because of women’s health issues.”
Dr Holdcroft said despite the outlawing of gender discrimination, women were excluded from clinical trials due to the impediments placed on their participation by research design. “In the UK and abroad significant barriers exclude the participation of women of childbearing age, regardless of their hormonal status. Women are often required to certify their use of contraceptives and rarely do protocols allow for exclusions of contraception such as celibacy or sexual orientation.”
Dr Holdcroft urges the implementation of best practices for healthcare research across genders: “With the advent to gender medicine as a specialty, a woman’s reproductive status, menstrual cycle and contraceptive history have become significant in studying health and disease. In the UK we should seize the opportunity to establish gender specific evidence based guidance.”
Dr Kamran Abbasi, editor of JRSM, said: “The persistent failure to include gender in design, conduct, analysis and reporting of studies is dismal. Professor Holdcroft raises fundamental issues not only for researchers and clinicians but also female patients, whose care depends on translating relevant research into practice. This sexual discrimination might make the lives of researchers and sponsors of research much easier but it doesn’t help patients.”
