CROs and sponsors need to ensure protocols are tailored to communities and that staff are representative to make trials more diverse, according to Parexel.
The US CRO made the comments in research – called “Discussions on Diversity” – published last month. The study gathered input from nearly 2,000 people from various ethnic groups in the US, Canada, the UK, Australia, France, Hungary, Italy, Mexico, Poland and Spain to identify “critical barriers to achieving diversity in trials.”
One of major barriers, according to the study, is the perception CROs and drug industry sponsors are not doing enough to understand patient, caregiver, and community preferences.
“The needs and preferences of patients, caregivers and communities must be carefully considered during study planning to ensure they address potential barriers to participation.
“The disease in question and the daily challenges it brings have a huge impact on how home or community-based strategies are deployed,” the authors wrote.
Another challenge for certain communities is that disease is stigmatized.
According to the respondents “there is a degree of stigma around illness in some communities, which is viewed as a contributing reason for lower levels of research participation.”
The Parexel team suggested decentralized studies – trials that let participants take part from home through researcher visits or remote monitoring technologies – could be used to adapt protocols to the needs of hard to reach communities.
Trust
The study also showed CROs and sponsors also need to do more to build trust in the communities in which they are trying to recruit.
The authors wrote “Building trust is critical to engagement in clinical research. Many patients expressed mistrust and skepticism around trial participation, often attributed to negative historic events and a lack of cultural sensitivity from the healthcare team.”
The trial sector must also ensure trial staff are representative according to Parexel, which said “Receiving treatment from site staff of the same race, ethnicity or cultural background was highlighted as important by many research participants.”
COVID-19
The coronavirus pandemic has highlighted the need to make clinical research more diverse according to Parexel, which said doctors that took part in the research highlighted this as a major concern.
“Physicians expressed a low expectation for COVID-19 vaccine trial participation from diverse communities, as well as anticipated low vaccine uptake, especially among the Black and African American communities, based on previous experience with flu vaccinations.
“The COVID-19 pandemic has created a spotlight on disparities in research access and placed a strong emphasis on diversity, presenting an opportunity to drive real change.”
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