In January, the FDA declared 2016 “The Year of Diversity in Clinical Trials” and shared a series of activities planned to advocate for more representation of women and minorities in clinical research. A push for more inclusion requires a community-wide effort; however, sites will play a big part in ensuring diversity, not only in medicines that are tested, but among patients.
The U.S. Census Bureau projected that half of the population will belong to a minority group by 2044. In order to mitigate risk for patient populations, it will be critical moving forward to ensure adequate representation in clinical research. For example, the Centers for Disease Control and Prevention reported that asthma prevalence is higher among multiple-race, Black and American Indian or Alaska Native than White persons. In a study conducted to treat patients with severe asthma in five countries, only 3% of patients were of African American descent; Native Hawaiian or Pacific Islanders made up less than 1% (See chart). Moving forward, it is critical to address these underrepresented patient populations to mitigate potential risk.
There are many steps at the site-level that can be taken to increase diversity in clinical trials. First, it is essential to identify nearby ethnic and minority communities. It is possible that recruitment efforts have overlooked these populations and there is plenty of potential to increase diversity of enrollment simply by raising awareness.
In situations where multiple languages are involved, it would be ideal to have bilingual or multilingual site staff. This is not always feasible; however, there are other options. Translating recruitment materials into the language of the targeted population is a good way to bring awareness of the study to others who may not otherwise have access to this information. Seeing advertisements in their native language not only informs, but potentially increases the level of trust the patient has in the research process.
Screening patients and enrolling them is only the first step—it is equally as important to keep them in the study. If there is a language barrier, consider hiring someone on a part-time basis who is able to communicate with patients in their native language and can act as their advocate. Make sure this staff member is present any time the patient is scheduled. If there are multiple patients natively speaking the same language, try to keep their appointments close together, if possible, to cut down on costs.
Another way to reach diverse populations is to find community groups and partner with them. Sponsoring an event or distributing educational materials is a good way to provide information regarding upcoming studies. Maintain ongoing relationships with these groups to build trust and stay aware of upcoming activity.
A potential barrier for patients, including minorities, may be the distance required to travel to the research site, lack of a reliable vehicle or access to reliable childcare. These obstacles can all be addressed and handled by the research site. Consider contracting with a car service to provide transportation to and from the site, or reimburse for cab fare. Allow patients to bring children along on their visit and provide a safe room for them to play in with a trusted staff member to supervise. If the distance is too great, and visits are close together, it may be helpful to establish a rate at a hotel nearby to lodge patients.
Of course, additional recruitment activity and outreach comes with a price. In order to combat the issue of underrepresentation in clinical trials, the entire research community will need to work together. Sites can be proactive about diversifying patient populations by making sure any additional measures that need to be taken are covered in the recruitment budget. This includes potential translations, travel costs or personnel hiring needed to make sure a study has all the appropriate resources.
Clinical sites are on the front lines of research and have the opportunity to set an example for the industry. Bringing awareness to studies and engaging an underrepresented patient population will lead to more complete data and ensure no demographic-specific effects are overlooked as new medicines are brought to market.
Dr. Christophe Berthoux has been the chief executive officer at Synexus since September 2010. Synexus is the world’s leading site management organization (SMO), dedicated to the recruitment and management of clinical trials across the globe for over 24 years. Synexus is proud to be the patient’s choice for clinical research. Email comments and questions to firstname.lastname@example.org.
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