DECENTRALISED CLINICAL TRIALS AND THE FUTURE
only trying pilot projects, she says. Guerra’s research on similar programmes at the University of Pennsylvania found that logistical barriers still prevent 40% of patients from taking advantage of financial reimbursement projects. Implementing these programmes can still be challenging.
Social determinants often ignored Studies show that if doctors ask Black individuals to join a trial, their responses are no different from the rate of white people wanting to participate, Guerra says, adding that both are at around 50%. The initial barrier is in the fact that patients are not asked to participate, and an unconscious bias probably has a role here, she adds.
The onus is on the research team and funders to create opportunities and support structures for diverse participants to be able to participate regardless of whether the participant is covered by private insurance or public insurance, Simon says. If patients do agree to participate, then they begin to consider how much time they will need to take off from work. This leads to fewer minority patients showing up at the door, says Guerra. If the trial involves multiple visits, for example, investigators may need to examine the necessary frequency of these visits, or the need to require them at certain centres, and consider the cost to a participant, says Simon. Often, neighbourhood programmes or
straightforward measures at recruitment centres can have the most impact. When it comes to prioritising diversity in trials, the field needs to think about it as early as possible to be sensitive to a community’s needs and get its input, says Dr Clayton Yates, professor, Department of Biology and Center for Cancer Research, Tuskegee University, Alabama. A more educated and engaged community will indicate the desired type of intervention or trials, he adds.
Outreach can be effective, especially when
organisations consider other healthcare staff, experts say. Patients turn to nurses or other healthcare workers when overwhelmed by information given by a doctor, and often, if they are also Black or Latino, rely on their opinion. Centres with bilingual staff that integrate clinical trials into regular practice have the
88 | Outsourcing in Clinical Trials Handbook
most success with improving diversity, says Minasian.
Most patients also do not have ready access to peers who have been in a trial or received treatment, says Guerra. To that effect, she spoke about a new clinical trial ambassador programme at the University of Pennsylvania where patients who have previously participated in cancer trials are matched with newly diagnosed patients from minority populations to help guide them through the trial process. The first batch recently graduated in a ceremony that included the surviving members of the family of Henrietta Lacks. Lacks’s family’s inclusion is especially noteworthy given the history behind the lack of consent in obtaining her tumour tissue sample, which is said to be emblematic of trust deficits between Black individuals and institutional healthcare.
The impact of COVID-19 The COVID-19 pandemic further widened disparities when it came to minority accrual to clinical trials. Due to the pandemic, cancers in general are being presented at a later stage because patients have missed screening appointments, says Yates. Yates, who was part of an inaugural
workshop led by Bristol Myers Squibb that announced a $100 million five-year initiative to train physicians on promoting diversity in clinical trials, says minority trial accrual was lower during COVID-19 because of lockdown measures, but it is picking up. Remote monitoring of patients can be a
positive way of reaching people in distant communities. However, decentralised trials would adversely affect minority representation in trials because there are disparities in broadband access, caregiver access, and insurance that provides home healthcare, says Guerra.
Not enough is known about overall patient
participation in such studies to understand the impact on minorities, says Simon. Still, Guerra notes that one of the provisions in the Diverse Trials Act allows sponsors to provide participants with the necessary technology, and requires the Department of Health and Human Services to issue guidance on how to conduct decentralised clinical trials in order to improve
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