Diversity in Clinical Trials: Why It’s Important, and How to Improve It
The clinicians that structure a trial or study have to take a variety of factors into consideration. What are the parameters of the trial? How long will it run? Who will be eligible to participate?
One common thread across most clinical trials is the need for diversity in clinical trial participants. It is critical to ensure that the trial is representative of the intended patient population, so that the trial is effective, and results are accurate across the larger population.
Why Diversity in Clinical Trials is Important
A trial may have different outcomes for different people - affecting participants of different ages, genders, races, ethnicities, etc. in different ways. When a trial covers a diverse population of participants, these outcomes can be studied and incorporated into the general understanding of the disease, medication, or treatment across distinct groups. And this improved understanding helps to improve prevention and treatment for all groups.
Sometimes, the treatment that is being tested can face challenges to acceptance by the general population. A trial that includes a variety of different types of people can help improve adoption and acceptance, as it increases the comfort level of patients to see that a medicine was effective for ‘people like me’.
Finally, participation in clinical trials can help to improve health equity across underrepresented groups, providing access to treatment options that may not be available through other avenues.
Current State of Clinical Trial Diversity
A recent study found that even today, participants in clinical trials are mostly white males. The study found that of 35 cardiovascular and diabetes drugs that were approved by the Food & Drug Administration (FDA) from 2008-2017, clinical trial participants were 64% male, and 81% white. Participants across all trials for 35 different medications were:
- 36% female
- 4% black
- 12% Asian
- 11% Hispanic / Latino
Even across a number of different trials, white males outnumber women and people of color by a large margin - one that is not representative of the general population. Without a diverse participant group, results can be skewed, and misunderstandings can occur - about conditions, prevention, and treatments.
How to Improve Clinical Trial Diversity
Check Eligibility Criteria
Take extra caution when developing the eligibility criteria for a study or trial, to ensure that the participant group that is selected is representative of the affected population. Without continuous review of criteria from the trial design phase, a group may be inadvertently excluded, affecting the validity of results.
A data-driven recruitment and eligibility strategy can help tremendously in ensuring that the participant group is statistically representative of the larger population.
Connect with the Community
Getting the word about clinical trials out to doctors and healthcare professionals within a specific community may help boost numbers across that group. For example, flyers, posters, and informational pamphlets in a women’s care clinic spreads the word about a trial that includes women, helping to increase participation.
Use all methods of communication and information distribution available. The easier you make it for people to be aware of a trial or study, get their questions answered, and sign up to participate, the larger a pool of potential recruits. And the larger the pool, the less difficult it will be to meet diversity standards.
This means connecting with participants in the real world, and the digital world as well. Don’t neglect a solid social media strategy - it is possible to increase your reach exponentially with a clever social media campaign.
Make it Easy
Using technology to simplify participant recruitment for clinical trials is critical. First, employ digital channels like social media, websites, and email to increase awareness. Then, make sure that people that are considering participation can access information - and get their questions answered - with a variety of options. Some people prefer to have a conversation over the phone, while others are interested in self-service options.
Finally, providing a signup tool that is as easy as clicking a button removes the final barriers to participation.
Research & Me supports diversity, equity and inclusion in the clinical trials we assist, helping to ensure clinical trials and studies represent the entire intended patient population, and the results are accurate across the larger demographic. For more information about how Research & Me can support diversity and inclusion in your digital trials, contact Research & Me today!