Making Clinical Trials Available to All

Clinical trials are an essential and fundamental component of bringing any new drug or treatment to market. The purpose of clinical trials is to measure the efficacy (meaning the ability to achieve an intended result) and safety (identifying, evaluating, and minimizing associated risks) of new treatments. Without patients on those trials, new drugs don't get developed. So, ensuring that these trials work for all – regardless of gender, ethnicity, age, or affordability – is a really important consideration the drug developers take when designing trials.

In each phase of clinical trials, volunteers are screened – typically by completing a series of questions and/or tests – in order to determine if they are qualified to participate and become patients. Within these patient groups, the goal is to create a group that accurately represents the larger population of people who will eventually end up using the medicine. Variables to consider may include sex (male/female), race/ethnicity, age group, culture and economics.

Inclusion in clinical trials is critical because differences in age, where someone lives, and biological makeup of different people can affect how certain treatments are received, their effectiveness, as well as any reactions that might occur. Ensuring that a treatment has been tested by a diverse group gives researchers valuable data and insight into how it might affect similar people within the general population.

For example, a white female and black female, who are the same age and in similar health might have a different reaction to the same medication. One might work better than the other. The same might be true comparing a white male and white female with comparable health and age.

And diversity in clinical trials goes beyond just considering race, sex, and age. Cultural, economic and regional differences across the world should also be considered. Differences in typical lifestyles across regions – diet and access to certain food/water, religion and beliefs, environmental health, and customs – can cause unique affects within those populations. It’s important to gain an understanding of all these differences, and their impact, during clinical trials.

Diversity and inclusion within clinical trials is vitally important. Advancements in research bring new drugs and treatments to the market. However, much of this research is gathered in clinical trial phases, with the findings there used to gain an understanding of how the many differences across clinical trial patients affect how the drug or treatment is working and any adjustments that should be made. Without a diverse group of patients, it’s difficult to know how different people will respond. Many of us rely on the availability, efficacy and safety of drugs and treatments. It’s an issue that will likely affect all of us at some point, whether personally or someone we know.