A statistical overview of diversity in clinical trials

Diversity is an essential aspect of medical research for many reasons. Ensuring equitable access to healthcare is vital, as it is a critical component of understanding the efficacy of potential new treatments and can improve the overall health of all individuals.

However, the focus on clinical trial inclusion is a relatively recent phenomenon, with many aspects of the industry still catching up to ensure that patient populations reflect the real world. As the industry looks forward to a more diverse future for clinical trials, it is also essential to understand how inclusion has shaped the history of clinical trials and how improvements can be made at every stage of the process.

A brief history of clinical trial enrollment and diversity

Since 1962, any new drug entering the market must be proven safe and effective before it can be approved, a process that is achieved through clinical trials. However, early versions of clinical trials centered almost entirely around the experience of white men, leading Congress to pass an act in 1993 that required the FDA to include more women and people of color in their research.

While this act was symbolically important, it only applies to studies funded by the National Institute of Health, representing just 6% of all clinical trials. Additionally, while the requirement has been upheld, actionable insights have not necessarily followed — even the FDA’s most recent address of racial disparity from 2020 simply contains guidelines for enhancing inclusion without clear rules or regulations requiring sponsors to take action.

Diversity in clinical trial statistics

Fortunately, these guidelines have allowed progress, though work still needs to be done. Countries have contributed to the FDA’s clinical trial data since the late 1990s, but trials have only become marginally more diverse over the past two decades. The first reports from the 1960s show that 92% of participants were white. Twenty years later, the figure had only dropped to 86%, much higher than the 76% of the total U.S. population who are White. 

Diversity is vital from an inclusion perspective and essential from a medical standpoint. According to a recent review of 167 new molecular entities approved by the FDA, approximately 1 in 5 were found to impact racial and ethnic groups differently. Since medical research aims to prove the safety and efficacy of potential new treatments, researching these elements thoroughly in representative populations is vital for the future of medical breakthroughs.

How to create more inclusive patient enrollment strategies

To move towards more inclusivity in medical research, it is crucial to understand what actionable items can be taken to increase diversity. Because of historical distrust, unconscious bias, and a general lack of healthcare access for marginalized groups, conscious strategies for improving diversity have to be implemented to enact actual change. Below are some actionable tips to address these three main barriers.

Addressing historical distrust: Medical institutions have gained a reputation for being exclusionary and unsympathetic to individuals from minority groups, but specific initiatives can address this engendered idea.

• Use outreach materials that include individuals from diverse backgrounds
• Highlight information about clinical trials’ importance and details about participation
• Staff sites with individuals that are representative of the target patient population
• Make sure potential participants’ questions are addressed and answered
• Share results about safety and efficacy from previous phases of the study

Correcting unconscious bias: Unconscious bias can come through in many ways, both in a study’s design and in how trial participants are treated by site staff. Some ways to correct unconscious bias include:

• Use outreach materials that are clear, concise, and written at the appropriate reading level
• Consider the study’s visit requirements and how they may impact individuals from different socioeconomic backgrounds
• Provide reimbursement for costs incurred by participating in a study, including travel expenses, childcare, or time off from work

Increasing healthcare access: Access to healthcare is something that individuals near research centers or prominent hospitals may not have to consider, but individuals living in more rural or remote places may be heavily impacted. Specific ways to increase healthcare access as it pertains to clinical trials are:

• Use sites in areas that are convenient to the patient population
• Train site staff on the study protocol so they are empowered to answer questions from participants
• Collaborate with advocacy groups that already work within patient communities to bridge the gap between researchers and individuals

At Antidote, we are committed to providing reporting, statistics, and dynamic outreach methods to ensure the clinical trials we recruit for accurately reflect every patient population. Get in touch today to learn more about our methods and how we can support your study outreach.