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Need for Diversity in Clinical Trials

Joey Gaspero

Clinical trials are essential to bringing new medicines to patients. An important aspect of clinical trials is to make sure that the drug is effective for a diverse group of people. Diversity in clinical trials has recently been a key issue. There is no comprehensive way of defining diversity, as it could include gender, race, ethnicity, sexual orientation, and more, depending on the dimension from which it is viewed. Unfortunately, many clinical trials lack diversity in representation.

A diverse nation like the United States has an assortment of populations, with White Americans forming the ethnic majority. Hispanic and Latino Americans amount to 16% of the population, making up the largest racial minority1. African Americans are the second largest racial minority, accounting for 12% of the population1. Adding to this is the international community which lands in the U.S in search of opportunities. Already diverse cities are becoming increasingly mixed with immigrants from Asia, Africa, and Latin America. The U.S. is a diverse country, so why do our clinical trials not reflect the same level of diversity?

Clinical trials are an essential part of drug development. These provide a base of evidence for evaluation of a drug. Each drug needs to be tested for its efficacy, ease of application, side effects, and many other factors before being launched into the market. The average drug developed by a major pharmaceutical company costs billions of dollars to develop. In general, the drugs are not specifically designed with every racial group in mind due to the cost of production. That is why clinical trials are an important tool to determine the drug’s effectiveness on the population as a whole. The trials are performed on a sample population and researchers try to prove its statistical significance on the entire population. Hence, it is very much essential for clinical trials to be diverse to represent the population. People from diverse cultures differ among factors such as their predisposition to diseases or the environment they are exposed to. To create awareness, the FDA announced 2016 as “The Year of Diversity in Clinical Trials.” Despite an increase in awareness, the current trend is unsatisfactory. According to the FDA, African Americans represent 12 % of the U.S. population, but only 7% of clinical trial participants. Additionally, Hispanics represent 16% of the U.S. population but only 1% percent of clinical trial participants2. In a country where minorities are estimated to outnumber white Americans by 2044, the inclusion of individuals of varied races, ethnicities, ages, gender, and sexual orientation in clinical trials can help to prevent disparities in the evaluation of potential new medicines2. Clinical trials ensure top quality drugs and diversity in clinical trials should be considered to provide better treatment.

The 7th Annual Diversity, Inclusion, and Life Sciences Symposium will discuss the trends, facts, insights, and best practices regarding diversity in clinical trials. Attendees will learn the newest insights and ideas, discuss practical solutions, and meet industry and marketplace colleagues. Please visit http://chisite.org/dilss/ for more info or to register.

 

  1. Source: Wikipedia
  2. Source: Center for Healthcare Innovation – DILSS 2016 Executive Summary
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