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Women in Clinical Trials for Biomedical Research | Medidata’s Diversity in Clinical Trials Series

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Women in clinical trials – Everybody is not the same when it comes to biomedical research

This blog was authored by Fiona Maini, Global Compliance and Strategy principal, Medidata, and Lauren Wheeler, Global Compliance and Strategy intern, Medidata.

Previously, we looked at the historical basis of women in clinical trials and the policies which began to turn the tide on the issue of women’s exclusion from clinical research. We also highlighted the importance of studying drug response by sex, due to the pharmacokinetic differences which exist between males and females, demonstrating the critical need to provide diversity in clinical trials regardless of gender.

How can we ensure equal representation for women in clinical trials?

Whilst we still have some way to go before we reach complete parity, the overall gender balance in human research studies worldwide has been more or less restored (however, it is important to note that significant disparities still exist in developing nations). This can be attributed to initiatives to increase the participation of women in clinical trials over recent years, including the NIH's Policy on the Inclusion of Women in Clinical Research and the establishment of the FDA’s Office of Women’s Health (OWH). The OWH funds research to advance the science of women’s health and has led to safety labeling changes, improved guidance for industry, and new evidence-based advice on the use of FDA-regulated products by pregnant women. The European Institute of Women’s Health (EIWH) is taking similar action to promote gender equity in public health, research, and social policy across Europe.

In 2016, the NIH also implemented a policy on the consideration of sex as a biological variable (SABV) in NIH-funded research1. This requires scientists to explain in their grant application how their research strategy accounts for this variable, such as by factoring it into study design and analyses. The policy states that "failure to account for SABV may undermine the rigor, transparency, and generalizability of research findings," and stresses the importance of gender-based reporting even where no significant differences are observed, since the results may be relevant to future meta-analyses.

The organization summarizes an approach to studying sex-gender to strengthen science research using ‘the 4 C’s’:

  • Consider – studies should be designed to account for sex or provide a valid reason for not doing so (e.g. developing a treatment for a condition that only affects men, such as prostate cancer)
  • Collect – scientists should collect and tabulate data according to sex
  • Characterize – sex-based subgroup analyses should be performed
  • Communicate – researchers should report on and publish sex-based data

What are the obstacles preventing women from enrolling in clinical trials today?

Even where the inclusion of women in clinical trials is promoted, many still face barriers to participation. This is especially true in low-income countries where females remain vastly underrepresented in biological research. Current obstacles which preclude women from being involved in research include childcare and working commitments, concerns about the impact on fertility or potential pregnancies, and lack of awareness or understanding of the trial.

A number of Medidata’s products and services are being employed to increase diversity in research and address some of the issues which have previously resulted in women being underrepresented in clinical trials. For example:

  • Providing better education through the electronic informed consent (or eConsent) system, part of Medidata’s Patient Cloud, can help to reassure women about the risks, or lack thereof, that participating in a certain trial might have.
  • Trial decentralization, or the use of virtual and hybrid trials, can reduce the time requirements and logistical challenges for patients. This lessens the burden on women, especially those who are primary caregivers, and increases the likelihood of them being able to enroll on a trial.
  • The advanced analytical tools offered by the RAVE platform allow for in-depth examination of results, ensuring that any sex-based differences in drug response are identified and can be used to inform future treatment recommendations and protocols.

Although we must continue to push for equality in biomedical research, especially in preclinical animal studies and early phase trials, the significant work which has been undertaken over the last few decades to promote women’s inclusion in research has revolutionized how we think about the influence of sex on drug response. It is exciting to be entering a period where better insights, combined with new technological developments, are allowing treatments to be tailored to each individual patient’s specific needs.

References

  1. NIH Policy on Sex as a Biological Variable
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