Importance Of Including Diversity In Clinical Trials

“Our ability to reach unity in diversity will be the beauty and the test of our civilisation.”

– Mahatma Gandhi

The beautiful tapestry of diversity is a stunning aspect of human beings. Our ability to exist and thrive in different forms and in different surroundings is what makes us truly beautiful. This diversity should be cherished and nurtured in every field of life of course, but its relevance in clinical trials is more than that.

In this article, we will talk specifically about the importance of including a diverse demographic in clinical trials. Before we begin, let us first revise what clinical trials are and why they are useful.

What Are Clinical Trials?

Clinical trials are essentially research studies conducted to examine a medical, surgical, or behavioural arbitration in people. Through these trials, researchers can determine if there is a growing need for any new form of treatment or prevention, such as a new drug, diet, or medical device. They can also determine if these new treatments are safe and effective in people.

Why Is Demographic Inclusion Important In Clinical Trials?

A basic fact of medicine is that the same disease can be experienced very differently by different people. This is why the inclusion of diverse demographics while conducting a clinical trial is important. Characteristics like race, ethnicity, age, and sex play a very vital role in these trials. When trials are held keeping these aspects in mind, all these communities will benefit from scientific and medical advances. 

When a group of clinical trial participants is diverse, the researchers can learn more about the safety and efficiency of a potential medication or treatment. These factors can differ based on age, ethnicity, race, gender, and sex, so if a clinical trial fails to include a wide array of representations, the results or findings will ultimately not be translated across all patient demographics.

Historically, clinical trials relied almost exclusively on white male participants. Unsurprisingly, this created a gaping divide in our understanding of diseases and conditions and treatment effectiveness across the globe. These gaps in information and knowledge can:

• drastically deplete the quality of health care,

• negatively impact the ability to counsel people on ways to reduce their risk,

• and ultimately deter the development of more effective medications and treatment methods.

An example of this was brought out in our recent blog:

Warfarin is an oral anticoagulant commonly used to treat and prevent blood clots. An adverse side effect of this drug was found to be excessive bleeding and incorrect dosing could even lead to death. Let’s see the relevance of diversity in this context. Here is an excerpt from the case study:

“The therapeutic requirements for warfarin differ by the presence of these specific genetic variants, and their frequencies vary substantially across genetic ancestries. For example, populations with greater genetic African ancestry are more likely to require higher average daily doses of warfarin (about 6 mg per day), whereas populations with greater genetic Asian ancestry require lower average warfarin doses (about 3.4 mg per day).

However, because most of the early genetic studies of warfarin were conducted in populations with predominantly European ancestry, dosing algorithms failed to adequately generalize to the diverse U.S. population. Indeed, even though warfarin has been approved for human use since 1951, it was not until 2013 that it was learned that genotype-guided dosing would be of clinical utility.”

Strides Forward

Modern researchers have swiftly made the daring shift into a more inclusive research method by including various and diverse demographics in their clinical trials.

Though the idea of including a wider range of representation during clinical trials has existed for a long time, this idea came to life during the COVID-19 pandemic. Seeing how widespread this pandemic was, medical researchers were forced to collect data from people of multiple demographics. To better address the issues posed by COVID, the FDA (U.S. Food and Drug Administration) even made strong efforts to encourage more diversity in clinical trials. In April of 2022, the agency even issued a draft guidance of recommendations to ensure adequate representation. 

“To enroll participants from diverse backgrounds, FDA also recommends that clinical trial sites should be located in areas with higher concentrations of underrepresented racial and ethnic patients and indigenous populations, as well as within neighborhoods where these populations receive their health care.”

It is vital for manufacturers to understand how potential treatments can affect different groups and whether the effects of a certain disease are driven by a particular genetic difference. Ensuring the inclusion of diversity in clinical trials must always be a top priority from the start. Everyone deserves a fighting chance to participate, contribute, and ultimately benefit patients from their own communities.

How Translation Can Bridge the Gap During Clinical Trials

When we talk about the inclusion of different demographics during clinical trials, the need for translation automatically plays a key role. Clinical trials are necessary for the advancement of human life but not all humans speak the same language. 

Translation is a crucial part of the Clinical Trial process and must be treated as such. An article put it brilliantly:

“Faulty translations may entail the ‘failure of the participant to act as instructed, disparities in prescription and administration of the study preparation, and reduced likelihood for appropriate follow-up and treatment of the underlying conditions and/or of side effects of the trial,’ (Eldar and Wexler 2009: 15), not to mention physical or emotional damage, misconduct of the experiment, time, and money.”

— Life Science Leader

The stakes are definitely high. Accurate translation is vital and can be a matter of life and death.

As an ISO 17100 certified translation company that specialises in Clinical Trials, we are passionate about getting it right for our clients. With over a decade of experience in clinical trial translation and with over 2000 linguists, we have served clients from all over the world in more than 350 languages. Reach out to us and let’s get talking about how we can help you with your translation needs.