SWHR’s goal for the future of clinical trials is to guarantee the inclusion of women in all phases of clinical trials with sufficient representation to allow for analysis by sex, ethnicity and other demographics.
This will only be achieved when clinical trials are appropriately and carefully designed to address the barriers that exist toward recruitment and retention of women and minorities. It will require an investment and collaboration by the biomedical industry, the medical community and our federal health agencies to make such changes. The success of such efforts should result in study data broken down clearly by sex, age, race and ethnicity. Peer-reviewed journals should be mandated to address the issue of representation in trials of sub-populations and reporting of sex-specific data. Specialized training for IRBs on addressing demographic disparities in trials should be explored. The resulting analysis will directly impact the health of men and women and can then be a part of medical education, public education and on prescription drug labeling.
Barriers to Women’s Participation in Clinical Trials and Research Programs
Despite some advances toward greater inclusion, women continue to populate many clinical trials in insufficient numbers proportionate with the disease prevalence in the population. SWHR believes that reasonable solutions exist to overcome the barriers.
Biases in Clinical Research
Historically, biomedical scientists and researchers have preferred studying male subjects for a variety of reasons including:
- First and foremost, the longstanding belief that women were just little men and that the only difference was in reproductive organs.
- Perceived costs and complexity of recruitment and inclusion of women in
- The desire both to protect a woman’s potential fetus (regardless of whether she is
pregnant, uses contraceptives, or intends to conceive) and to avoid legal liability
from prenatal exposure.
- The potentially confounding effects of women’s hormonal changes.
SWHR broke down these rationales and sought to have it understood by the scientific community that:
- The inclusion of women in clinical trials potentially facilitates the development of
more targeted prevention and treatment strategies.
- The discovery of differences between male and female response to disease and treatments has implications for both genders in clinical practice, disease prevention and manifestation, and medical education.
- The logic that the exclusion of women protects them (or their potential fetuses) is problematic in that protecting women from exposure during research means that women’s exposure to a drug being tested is merely delayed until the drug is released and on the market.
- The fact that a woman’s physiology does change through out her hormonal cycle makes the study of the impacts of these changes crucial.
- Physicians should not prescribe medications studied only in male subjects and ignore important sex and gender differences in treatment and effect.
- Women have different needs than men.
Some Progress but Not Enough
Read more about the history of clinical trials legislation »
The exclusion or lack of sufficient numbers of women in many studies led researchers to infer that the results of these studies were applicable to women, regardless of any sex-based differences in the treatment and prevention of diseases. In the last decade, a greater awareness of this situation has propelled an increase in research on women’s health.
Despite the very real progress that has been made toward greater inclusion of women in research programs and clinical trials, especially at the NIH, a great deal more needs to be done to achieve the levels of participation necessary to achieve an understanding of the biomedical differences between men and women.
Biomedical clinical research outside the NIH, where approximately 80% of clinical trials are conducted, has not achieved the same level of success on inclusion of women. To a certain extent very little improvement has been made in recent years and that is where SWHR’s long-standing concern regarding the barriers that preclude women from participating in and staying in clinical trials remain of tremendous importance.
Now is the time to make the effort to include women in all phases of clinical research to determine correct dosing and toxicity. SWHR believes that wherever barriers exist to fair and appropriate inclusion of sex and gender in medical research strategic efforts must be made to minimize or eliminate them if we are to achieve appropriate participation levels that will provide the results that will lead to improved health for all women. Without sufficient representation to allow for analysis by sex, ethnicity, and other demographics sex differences research can’t be done.