A Look at Gender Representation in Clinical Trials for Students in Clinical Research Courses

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When conducting clinical trials, results can depend on how diverse the population of participants is. Clinical trial diversity is essential for:

  • Accuracy
  • Effectiveness
  • Reduction of bias

Gender bias in particular is an issue currently being addressed within clinical trials. Because there has historically been a bias towards male study participants in medical research, there is a lack of data by comparison on females and how they react to drugs.

Read on to learn why gender diversity in clinical trials is so important, and what can be done to improve it!

Why Inclusion Is Important to Graduates of Clinical Research Programs

There are disparities between populations receiving treatments and the populations that participate in clinical trials for these drugs. This means that drugs can be approved for market but still create problems or be less effective on some patients who use them. Examples of studies excluding women include:

  • Cardiovascular clinical trials, of which only 31% include women and report results separated by sex
  • A study using Flibanserin, a medication for pre-menopausal women, that only had 8% female participants
Lack of gender diversity in clinical trials can lead to women being underserved and endangered

Lack of gender diversity in clinical trials can lead to women being underserved and endangered

Exclusion of women in clinical trials is historically due to several old beliefs:

  • Studies on men could be applied to women as well
  • The fluctuation of hormones that women experience would complicate studies to the point of skewing results
  • The possibility of women being pregnant presented too high of a safety risk

Grads with a Clinical Research Diploma Know the Benefits of Gender Diversity

There are many reasons why graduates of a clinical research program want gender diversity in clinical trials. Gender diversity is important in clinical studies for many reasons, such as:

  • Determining that drugs are safe for women to take
  • Proving efficacy of treatment in women
  • Showing side effects that only appear in men or women, or appear more intensely in a particular population

The bodies of men and women will react differently in some cases when taking drugs, because:

  • Drugs are absorbed differently
  • Metabolisms are different
  • The way that drugs are excreted changes
  • Weight and size varies, affecting dosage
Gender diversity can provide more helpful information when approving drugs for market release

Gender diversity can provide more helpful information when approving drugs for market release

Steps Being Taken to Be More Inclusive in Clinical Trials

If women aren’t included properly in clinical trials, they can miss out on:

  • Prevention of diseases or illnesses
  • Effective treatments
  • Warnings of side effects

Lobbying for women to be included in clinical trials increased in Canada in the late 90s, when attention was drawn to the lack of research in breast and female reproductive cancers. Gender Based Analysis was implemented by Health Canada to address these issues.

In addition, there are organizations working to include more women-centred clinical trials. The Women’s Health Research Institute in British Columbia is one of these organizations, with a team that supports and facilitates trials focusing on females.

While there is still a ways to go in terms of including trials that focus on women, at this point 43% of participants in worldwide clinical trials are women. When you complete clinical research courses, you may be inspired to make a difference in your own way.

As steps are taken to improve gender diversity, drugs can become safer and more effective for women

As steps are taken to improve gender diversity, drugs can become safer and more effective for women

Are you interested in getting a clinical research diploma?

Contact AAPS for more information!