The statistics illustrate that clinical trials fail to adequately recruit women as subjects, but even more worrisome is the fact that researchers consistently fail to analyze data of clinical trials with sex-specific results in mind.This creates a serious problem: patients, with no sex-specific data to consider, cannot make informed decisions about undergoing treatment.
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The risk of long-term damage to reproductive organs and ensuing potential for lawsuits discourages both sides, researchers and women, from seeking equal representation.
Despite the challenges of including women in clinical trials, such exclusion is scientifically infeasible – it is for the exact reasons that researchers exclude women that fair inclusion of women in clinical trials is crucial to developing targeted prevention and treatment strategies. A 2002 NIH Institute of Medicine report emphasizes that sex is “an important basic human variable that should be considered when designing and analyzing studies in all areas and at all levels of bio-medical and health-related research”.
Ultimately, limiting female participation in effect restricts the right of equal access to treatment.
Furthermore, female underrepresentation is not strictly a woman’s problem.
Therefore, sex-specific analysis of trial data is urgently needed to identify these adverse drug reactions before a treatment is on the market.
The perception of women as a vulnerable group highlights the conflict between protecting women and denying them access to life-saving technology.
A pregnant woman who falls ill and has no choice but to take an unknown drug will essentially “participate in an uncontrolled and unmonitored experiment for which the data will most likely never be assessed”.
In such cases, researchers can collect data from women who had to take unknown drugs while pregnant.
Although the mechanisms of sex-based differences have been elucidated, the relationship between these facts and differential drug response remains poorly studied.
If important sex-based differences can be identified in the early stages of a clinical trial, the later phases “can be designed more suitably to further clinical understanding of the appropriate use of drugs for women”.
The 1977 Food and Drug Administration recommendation that “women of childbearing potential [be] excluded from the earliest dose-ranging studies” mirrors this outlook and effectively violates the principle of informed consent and restricts a woman’s autonomy.