CClinical studies are considered the top method for determining if medical treatments are effective. They serve as the foundation for whether medications receive approval from the FDA, and they help show a drug's effectiveness while identifying any potential safety concerns. During these studies, participants are assigned to different treatments randomly, and their health results are tracked.
Studies are carried out on just a limited portion of the population that might eventually get the treatment, though. The expectation is that the findings from patients participating in the study will eventually apply to the larger group receiving the treatment.
Ideally, the participants in a clinical trial should represent the variety of the population that will use the medication, but in reality, this isn't always the case. Trials frequentlyunder-enrollwomen, seniors, and underrepresented groups.
The lack of adequate representation of these groups can lead to significant effects.
For instance, in 1992, the FDA approved Ambien (zolpidem), a medication designed to address sleeplessness. As women typically process the drug at a slower rate compared to men, they need smaller amounts to prevent extreme tiredness. Nevertheless, women wereunderrepresentedin the initial stages of clinical testing, this point was ignored, and it wasn't until 2013 that the FDA formally recognizedrequireda smaller dose for women. The results of this neglect included over 700 reports to the FDA regarding traffic accidents that may have been influenced by this factorattributed to this dosing.
Such examples demonstrate the significance of ensuring clinical trials are inclusive. Regarding women, one approach could be increasing the number of female researchers leading these studies.
In a recent study, we investigated the concept by looking into whether clinical trials conducted by women are more inclined to recruit female participants.
We collected information from over 10,000 clinical studies carried out during a 15-year period, connecting details about the gender of the researchers who headed these studies with data regarding the gender distribution of participants in each trial.
Since female researchers might tend to focus on conditions that affect women, such as breast cancer, and male researchers might be more inclined to examine diseases that impact men, like prostate cancer, we ensured that the specific disease being studied in a trial was explicitly considered to address this possible source of bias.
We discovered that studies conducted by female researchers tended to have a higher proportion of female participants. On average, 54% of the participants in trials led by women were women, whereas this figure was 47% in trials headed by male investigators.
We also investigated the reasons why trials led by women may attract a higher number of female participants.
Initially, we discovered that studies conducted by female researchers were more inclined to have female personnel. The research staff in clinical trials are typically the first point of contact, performing a crucial role in engaging with and enrolling participants. A higher number of women on the team might enhance the participation of women, particularly if female trial participants feel more at ease communicating with other women.
Second, because of increased regulatory demands and the perceived legal risk, numerous clinical trials often exclude pregnant women even when there isn't a clear justification for this (for example, certain medications can be detrimental to the fetus, making it standard practice to exclude pregnant individuals in trials involving these drugs). We observed that female researchers were less inclined to exclude pregnant women from clinical studies.
So, what do these findings indicate?
If women are not adequately represented in studies, the results of these scientific investigations may not apply effectively to them. This imbalance in clinical trial participation suggests that treatments given to women in practice might not have the same level of supporting evidence as those for men, leading to concerns about the safety and effectiveness of these treatments.
Our research indicates that boosting the participation of women in clinical trials, and ensuring that safety and effectiveness standards are equally applied to both genders, can be achieved by having more female scientists heading these studies. Groups such as the National Institutes of Health, universities, and corporations have introduced encouraging programs, yet the number of women leading clinical trials remains lower than that of men.
Boosting the percentage of female clinical trial personnel could also be beneficial. Our research suggests that one potential reason why trials led by women researchers include more female participants is because women researchers might utilize more female frontline staff. Female staff may make greater efforts to recruit women into clinical trials, or alternatively, women might be more inclined to participate if the person they interact with during the trial is a woman. Training these individuals could be an effective method for enhancing the participation of women in trials.
The significance of enrolling a variety of and reflective participants in clinical trials stems from the obvious reality that medical treatments can and do have different impacts on various groups of individuals. We must aim to make sure that clinical trials reflect the populations that the treatments are meant for, and one approach to achieve this could be to ensure that the trial teams themselves are diverse as well.