Developing Clinical Trials for Your Intended User

by | Nov 18, 2020 | Clinical Trials, FDA, Medical Devices, Quality, Regulatory, Requirements

For the past few decades, the FDA has been attempting to increase the diversity of individuals participating in clinical trials. Specifically, they are trying to encourage any companies conducting clinical trials to include the demographics that will primarily be using the drug upon market approval. While this may seem like an obvious requirement for clinical trials, this is not historically how things have worked. Due to various socio-political conflicts throughout the past century, it has been easiest for most companies to use healthy Caucasian men in their clinical trials. This is not an ideal situation, as healthy Caucasian men do not represent the entire population of people who use drugs, even if this is being solely considered from a physiological standpoint. For example, if your company is developing medicine for breast cancer, the ideal population for that clinical trial would be the group of people most likely to develop breast cancer: women.1

There are innumerable examples such as this, where healthy Caucasian men are not the target audience for a drug, and thankfully, the FDA has realized this and started working toward a solution. In the past month, the FDA has released a guidance document, “Enhancing the Diversity of Clinical Trial Populations – Eligibility Criteria, Enrollment Practices, and Trial Designs”. This document is meant to be a comprehensive guide on which demographics make the most sense to include in your clinical trials. It goes into detail about:

  • Broadening eligibility criteria for participants, such as allowing older adults, children, pregnant women, and people with rare diseases
  • Making an effort to be more equivalent in terms of sex, race, ethnicity, and socioeconomic status
  • Making trial participation less burdensome on participants, by making sure that your facility is accessible for many different types of people, and by offering financial reimbursement for participants
  • Putting more thought into how you are advertising participation in your clinical trial to be sure that you are reaching a wide variety of types of people2

In some cases, the population a company would want for their clinical trials is obvious, but there are some cases where the best population is less clear. A great example of this is a drug developed to treat late-stage liver disease; while it would be most helpful to test this drug on people who are in late-stage liver disease, being in these trials would be incredibly dangerous for people of this demographic. The end goal is to try to outweigh the benefits to society with the potential harm to any individuals participating in the trials. If your company is unsure of how to proceed in the world of clinical trials, our regulatory experts at EMMA International can help you make those tough decisions in a way that will comply with the FDA standards and recommendations. Contact us at 248-987-4497 or info@emmainternational.com for additional information.


1Liu, K. A., & Mager, N. A. (2016). Women’s involvement in clinical trials: historical perspective and future implications. Pharmacy practice, 14(1), 708. https://doi.org/10.18549/PharmPract.2016.01.708

2FDA. (2020, November). Enhancing the Diversity of Clinical Trial Populations. Retrieved November 16, 2020, from https://www.fda.gov/regulatory-information/search-fda-guidance-documents/enhancing-diversity-clinical-trial-populations-eligibility-criteria-enrollment-practices-and-trial

Catherine Milford

Catherine Milford

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