Logistical and financial barriers have created significant barriers to clinical trial participation, resulting in historical under-representation of minority populations in clinical trials. As the industry seeks to counter past shortcomings, sponsors in the O&P space must utilize proactive strategies to recruit diverse populations to ensure appropriate diversity.
Diversity in O&P Trials
In the United States, race is a significant predictor of limb loss. Consider the case of amputations related to diabetes. A study in BMJ Open Diabetes Research and Care Journal found racial and ethnic disparities exist in the risk for lower-limb amputations, with an increased risk of major amputations among Black and Native American Medicare beneficiaries compared to those of whites. According to another study from Dartmouth, Black Americans are losing limbs at a rate triple that of other groups. Despite these numbers, minorities are historically underrepresented in clinical trials.
Among the primary considerations in planning for trials is understanding why specific populations are underrepresented to design trials to address those recruitment challenges before enrollment even begins.
In the O&P space, a significant challenge for achieving diversity in clinical trials is a lack of homogeneity in etiology for specific conditions. This means there are smaller pools of potential recruits available. A smaller pool of recruits requires sponsors to recruit strategically, using targeted outreach to participants, specialty care teams, and advocacy groups to achieve a representative cohort. Dedicating resources to reduce participation barriers and providing patients with education and additional support—logistical, and even emotional—can make significant strides in improving recruitment and diversity.
A Focus on Patient Support
Sponsors must take a highly patient-centric approach to design a successful trial. This begins with understanding the concerns of the participants. What would lead someone to skip an experience that could provide a better quality of life? Is this an issue that can be overcome or mitigated with patient support services?
For example, are potential participants in a lower socioeconomic tier making time off work or paying out-of-pocket for travel difficult? If so, would prepayment of expenses help with recruitment? Does the physical condition of the participant make travel painful or difficult? Is the planning involved just too overwhelming?
One proven solution to improve diversity and increase retention in trials is for sponsors to provide personalized support services for participants and caregivers. Some trial logistics partners offer dedicated coordinators assigned to each participant, who provide expert guidance in navigating the complicated logistics that frequently accompany O&P trials.
Participant coordinators provide personalized, compassionate support to accommodate the unique needs of each participant. This includes planning for all possible inconveniences and taking proactive steps such as arranging wheelchair-accessible vehicles, oversized SUVs, ADA-accessible hotels and restaurants, and facilitating special requests with airlines. They also prepare for unexpected or last-minute hurdles that require quick action to change travel itineraries. If the participant incurs out-of-pocket expenses related to the trial, their personal coordinator will ensure prompt reimbursement.
Understanding the needs of the unique O&P population and offering support resources significantly reduce participation barriers. This, in turn, improves recruitment and trial diversity, the quality of the participant experience, and retention rates, resulting in a more efficient study and projectable results for the broader O&P population.
Scott Gray is cofounder and CEO ofClincierge. He is a recognized leader and innovator in the world of medical meetings, patient-centered clinical trial support, and healthcare logistics. Scott is dedicated to improving patient-centricity in clinical trials and general medical treatments.