1:15 PM
Oct 04, 2018
 |  BioCentury  |  Politics, Policy & Law

Research from Mars can fail patients from Venus

Guest Commentary: Jim Greenwood says industry needs to improve on inclusion of women in clinical trials

Despite rules and directives pushing for clinical trials to include proportional representation of both sexes, some researchers and developers are still behind the curve. FDA, BIO and nonprofit organizations are providing new tools and resources that can help ensure diverse patient populations receive the full benefits of newly commercialized medicines.

Historically, federal dollars flowed to medical research with a disproportionate focus on men’s health.

There are several reasons for this. Decades ago, many scientists shortsightedly concluded men were easier to study because they weren’t subject to frequent hormonal changes that could complicate a study’s design or the interpretation of its results. Also, safety concerns for pregnant women once resulted in overly broad exclusions of women with “child-bearing potential” from many clinical studies.

The last quarter-century has brought a greater focus on the opportunity cost of uneven representation in clinical studies. When it comes to gender, in particular, we now know unequivocally that a person’s sex can influence disease presentation, diagnosis, severity and treatment.

Biopharmaceutical leadership teams should have firsthand expertise in the biological realities and cultural considerations of the different populations they serve.

Certain chemotherapy drugs have more side effects in women than men. Women may need lower dosages of certain medications due to differences in body weight compared with men. Research suggests that women may be 20 to 70% more likely to develop lung cancer than men who smoke the same number of cigarettes. Meanwhile, colon cancers...

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