The under-representation of racial and ethnic minorities in clinical trials is a well-known issue facing the life sciences industry today.
Studies have shown that certain populations can respond to the same medical therapy very differently. Multiple studies in various therapeutic areas provide compelling evidence that disparities exist resulting in worse outcomes for minority patients. However, most clinical trials are primarily homogenous and often not reflective of the disease burden or prevalence in a population that the product is intended to treat. Industry and regulators have recognised that increasing the diversity of patient participants in clinical trials is one significant way to address some of these issues.
The research community continues to face challenges around patient scarcity, as well as garnering diverse and representative populations among clinical trial participants. With the exponential increase in highly complex clinical trials, finding enough of the right patients is one of the biggest challenges in clinical development. Gender and ethnic diversity gaps can lead to less than ideal circumstances for the development of new treatments and can further exacerbate minority health issues. Without diverse representation, you are not able to identify or mitigate different drug effects of a study in a given population.
There are many barriers that have been identified as to why there is such a lack of participation in trials by minorities. However, there are three key reasons why minorities do not participate in clinical trials that keep resonating to the top: lack of trust of the research community; logistical and time constraints; and lack of clinical trial awareness.
How can we ensure clinical trials and research become more diverse? Here are a few suggestions:
- Drive better understanding of clinical trials: The structure of healthcare provision in diverse and under-represented communities can pose a challenge. Where having access to healthcare is less of a barrier in Europe than it is in the US, there is virtually no understanding of the clinical trials process amongst the general population. Also, for physicians treating ethnic minority groups in dense communities, particularly in underprivileged areas, they often have many patients to serve. These physicians are typically short on time and may not be knowledgeable about clinical trials themselves. Providing education about the clinical trial process and the importance of participation in clinical research may help with increasing minority enrolment. Developing culturally appropriate educational materials and offering services directly to the patient community is a way to help improve understanding.
- Ensure the community understands the patient’s well-being and safety always come first: The bottom line is that for minority communities to be engaged, we need to demonstrate an opportunity for relationship building and partnership. For true collaboration, the patient must trust the research process and be treated with the utmost respect for their integral role in a clinical trial. Therefore, the key to patient recruitment is driving trust – if people trust you in your first interaction, they will be more likely to enrol in a study. Understanding racial and cultural sensitivities plays a large part in building trust, and physicians from outside the community may not be best first point of contact to engage with patients or caregivers. If there is already a team from the community on-site who are experienced in the specific area of research, they should be able to take the lead. It may run counter to normal practice to engage external clinicians in this way, but it’s the only way you are going to bring more diverse patients into the circle. If we are more diverse as a clinical research community, that will be a powerful first step to increase representation of clinical trial participants. Equally, bringing the family into the consent process to support the patient can help with patients being willing to participate.
- Increase the patient pool and make it easier for patients to participate: We all know that the time and travel requirements to participate in a clinical trial are burdensome for the general population and is no different for minorities. Making it easier and more convenient for patients to participate in a trial is one way to help with minority recruitment. Using digital and virtualization of clinical trials, not only can you expand the geographic reach of patients that may not ordinarily be served by the investigator sites, there may be the potential to minimize patient burden by conducting some aspects of the trial remotely. Technology that is used in everyday life such as wearables, smartphones and tablets make it easier to participate. Minority patients at all socioeconomic levels tend to over index on mobile technology, so the use of technology as part of the study would be an added incentive for participation.
- Improve community physicians comfort level of clinical trials: Many minorities do not participate in clinical trials simply because they were not aware of them. They were never asked, nor were they inclined to seek out a trial on their own. The research community can do a better job of connecting with the community physicians to increase awareness of clinical trials. Support can be provided to physicians with resources that can be used to facilitate a discussion about the benefits and opportunities clinical trials with their patients. Typically, the treating physician is the key conduit in which a patient becomes aware of a clinical trial. The research community will need to make sure community physicians understand and are comfortable with the clinical trial process. As minority patients tend to put a high degree of trust with their personal physician it is often through that physician recommendation that a minority patient will enrol in a study.
- Collaborate with Patient Advocacy Organisations focused on raising awareness for clinical trials: Engaging with organisations focused on building relationships with patients and patient advocates to raise awareness about clinical research will help industry reach more patients. Organisations like CCTA, EUPATI, and ECRAN work with industry and patient advocates and focus on address issues like diversity, trial design, and access.
Solving the challenge of increasing minority participation in clinical trials requires a long-term commitment and investment from the research community. Supporting both community physicians and minority patients in the clinical trial process is critical in increasing the number of minority participants.
Naima Lockhart Gibson is product marketing director, mHealth Portfolio, at Medidata Solutions