Identifying and implementing ways to increase diversity in clinical trials is a growing topic in the industry. Almost 40 percent of Americans belong to a racial or ethnic minority, but roughly 80-90 percent of participants in clinical trials for new drugs are still disproportionately Caucasian. In order to make sure drugs and treatments are safe and reliable to all people, there needs to be a better representation of minorities in clinical trials.1
We know there is this strong need, but how can we as an industry unite to make it happen?
When it comes to clinical trials, minorities are participating less because of2:
• logistical challenges (lack of time, no transportation to and from clinical site, cannot miss work)
• financial reasons
• distrust in clinical trials from past experiences, like the Tuskegee syphilis experiment
• pre-existing health conditions, such as hypertension and diabetes (narrow inclusion criteria and extensive exclusion criteria of some trials disqualifies these individuals)
Once we understand these barriers, we can work to find solutions to overcome them.
Traditional advertising is even adapting to the new digital world. Think of apps like Pandora, Spotify, iHeart Radio, and Hulu. The way users are engaging with traditional media may have expanded, but it's all still traditional media at its core.
One of the most effective ways to get your clinical trial information in front of your intended patient population is to understand how they want this information presented to them. Ethnicities and culture, education, and available resources (internet, etc.), all have a strong impact on where individuals look for information related to healthcare.
Spend time researching the best method of communication for your target audience. If you have a trial where the Hispanic community is your patient population, for example, focus on sharing information via word of mouth. One method of recruitment for your trial could be a strong emphasis on community awareness events, where a trusted member of the community is present to educate attendees on your clinical trial.
The best way to overcome the uncertainty surrounding clinical trial participation within minority communications is to focus on rebuilding their trust.
Every company involved with executing and recruiting for clinical trials should put effort towards building strong and honest relationships within these communities. Reach out to valued members and organizations, as these individuals are who community members will listen to regarding the importance of clinical trials and study participation.
There are many misconceptions about what a clinical trial is, and with those misconceptions often comes fear in participating. An educational campaign on what clinical trials are and why they are both necessary and important can work to combat these misunderstandings and hesitations.
Share how clinical research can make an impact on both a personal and communal level. Participants in clinical trials are paving the way for future treatment options. Without clinical trials, many of the medical advancements over the years would not have been possible.
Equally important to educating generally about clinical trials is educating about your specific trial. Simply creating a basic flyer with a phone number and a direction to “call for more information” won’t lead to much participation. Instead, offer educational materials that provide a strong overview of the study: what the study is for, why the study is important, and what is expected of the participant.
If people have a clearer understanding of what is being asked of them and the why behind their participation, they are better able to make an informed decision about joining the trial.
While a focus on outreach to the communities is important, this can be a moot point if there are no study sites located within these communities. Many times, sites are selected for studies because they have been previously selected for other studies. It becomes habit to continue down a path that is most comfortable or familiar. To break out of this cycle, research new sites for your studies. Identify and select sites who will provide you with access to diverse populations.
When planning a recruitment strategy, there are specific tactics that will help you enroll a diverse population into your study:
• Present your study information and content in a relatable way that is easy to understand. Using scientific or technical language can be overwhelming to individuals without a scientific background.
• Identify the ways each sub-population wants to receive healthcare and medical information (face-to-face, word of mouth, internet search, social media, etc.). Tailor your outreach or media efforts around their preferences.
• If your materials will be used in areas where English is not the primary language, translate materials for the community’s native language.
• Take into consideration their culture and religious beliefs, making sure the information will not be perceived as insensitive.
• Use a variety of images in your materials, highlighting individuals from many races and ethnicities.
It is no hidden fact that including diversity in clinical trials is necessary. When segments of the population are underrepresented in clinical trials, we are not able to conclude how the investigational drug will work for or effect certain groups of people.
While we have made great progress in addressing and identifying this need, it is time to implement the changes necessary to overcome it.
1https://www.statnews.com/2019/08/23/clinical-trial-recruitment-diversity-community-engagement/
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If you’ve been following along with our past blogs, you have gained insight into:
You're going through the checklist of everything needed to get the awareness efforts for your study up and running:
You have:
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