Clinical Trials: Greater Inclusion of Women

The National Women’s Health Network (NWHN) advocates for the greater participation of women and other key groups in clinical trials for all drugs and devices, and particularly for products that are principally marketed and used by women.

Age, gender, race, and ethnicity can all have a profound impact on the body’s response to medical products. Differences in drugs’ and medical devices’ effectiveness and safety can result from intrinsic factors (i.e. a person’s genetic make-up or metabolism) or extrinsic factors (i.e., the effects of racism, poverty, poor diet, environmental exposure to toxins, etc.). They may also result from or interactions between different factors.

There is a strong body of evidence showing that what a drug does to a body and what a body does to a drug can vary based on these factors. For example:

  • The sleeping aid Ambien was originally approved at a dose two times higher than is safe for women, increasing the risk that a woman will experience dangerous levels of sleepiness the next day. According to a 2001 study, eight in ten drugs recalled from the U.S. market were found to pose a greater health risk to women than men.
  • Compared to persons of Asian and African heritage, Whites are more likely to have abnormally low levels of an important enzyme (CYP2D6), which affects the metabolization of drugs such as antidepressants, antipsychotics, and beta blockers.
  • As people age, their kidneys and liver do not work as well, and the amount of water and fat tissues in the body change. These and other factors impact how older people process the drugs they take, how long those drugs stay in the body, and what side effects they experience.

We can’t know how safe and effective drugs and medical devices are different people unless we include all types of people in clinical trials; analyze the trial data for sex-, race-, ethnicity-, and/or age-based differences; and clearly communicate these results to the public and health care providers.

Surprisingly, this doesn’t happen right now. For example:

  • Women make up approximately 61 percent of patients with Chronic Obstructive Pulmonary Disorder (COPD), yet, in 2 recent trials for new COPD medications, only about 25 to 31 percent of the participants were women.
  • Although African Americans develop lung cancer at a higher rate than Whites, fewer than 2 percent of lung cancer trial participants are African American.
  • Hypertension is more prevalent as people age; about 70 percent of people over age 65 have hypertension. Yet, fewer than 30 percent of participants in clinical trials for a new hypertension medication are over age 65.

Because women, the elderly, and people of color are under-represented in clinical trials, we often don’t know about drugs’ and medical devices’ dangers until after the products have been used and reported to cause harm. For this reason, the NWHN and our allies have long pushed the Food and Drug Administration (FDA) to require clinical trials to specifically include key populations, such as women, the elderly, and people of color.

We applaud the FDA for making significant progress on these issues, and for its creation of an Action Plan in 2014, laying out the agency’s efforts to increase participation of women and people of color in clinical trials. The FDA Action Plan included several of the NWHN’s recommendations, including: ensuring greater transparency in the collection and analyzation data on different sub-groups; creating incentives to improve clinical trial participation among women and people of color; providing clear guidance to drug manufactures on the parameters of inclusion of subgroups and the analysis and reporting of these subgroup data.

This is a step in the right direction, but more needs to be done to ensure the Plan is fully executed. The FDA must require — not just remind or encourage — industry to ensure that women, people of color, the elderly, and their health care providers have complete and accurate information to guide medical decisions.

We urge the FDA to improve its Action Plan by:

  • Addressing concerns about the under-inclusion of women, the elderly, and people of color in all phases of research trials;
  • Requiring additional, standardized information on sex-, race-, ethnicity-, and age-based differences in medical product labels;
  • Establishing the consequences of not collecting or analyzing data on women, people of color, and the elderly; and
  • Clearly communicating these consequences to the drug and device industries.

Women and their health care providers need complete and accurate information about the medical products available to them. They particularly need information about specific risks and benefits that may occur due to race, ethnicity, gender, and/or age. The current lack of information exposes women to dangers that can be avoided by more inclusive requirements for clinical trials.

The NWHN continues to monitor implementation of the FDA Action Plan and urges the FDA to establish strong enforcement mechanisms to hold companies accountable. For more information about the inclusion of women in trials, please click here.

We are committed to ensuring that women have access to accurate, balanced health information and services. Stay informed about this issue by signing up for our e-alerts, and by connecting with us on Facebook and Twitter.


Updated August 2015