The US Food and Drug Administration (FDA) recently released the draft guidance on enhancing diversity in clinical trial populations. The document is open for comment until August 6, 2019.
“This draft guidance suggests that sponsors of clinical trials take a more active approach to inclusiveness in clinical trials, specifically calling out opportunities to broaden eligibility criteria and consider logistical and financial resources to make trials more accessible while designing the research program,” said Greenphire CEO Jim Murphy.
The draft guidance also suggests including children and adolescents in adult studies when appropriate, though Naor Chazan, CMO of TrialScope, proposed expanding trials for older adults who are often excluded as well.
“In its recent draft guidance, the FDA suggests engaging patient advocacy groups, particularly for rare diseases,” Chazan told us. “However, we have found that collaborating with patient advocates for all types of conditions vastly improves patient-centric communications and can lead to greater diversity.”
Collaborating with patient advocates is among one of several approaches to improving patient enrollment and retention, not the least of which is financial assistance.
“The FDA doesn’t consider reimbursement for reasonable travel expenses to cause undue influence and as such, sponsors looking to broaden their participant base would be well-served in offering automated patient payment solutions to promptly reimburse out-of-pocket costs and proactively provide travel support to eliminate the hassle and cost of local and long distance travel associated with trial participation,” said Murphy.
Still, there are other indirect costs of trial participation that could be offset by providing stipends – payments to patients in exchange for their “time, inconvenience, and discomfort,” Murphy added.
The draft guidance also suggests the use of adaptive trials, which are being enabled by the proliferation of new mobile technology tools. Murphy explained, “In addition to face-to-face visits, supplementing clinic visits with electronic communication can provide investigators with real-time data and at the same time make a clinical trial inclusive of diverse populations for whom transportation and visit time may be an obstacle.”
Lack of awareness, fear, and mistrust
While the NIH Revitalization Act of 1993 requires all federally-funded clinical research to prioritize women and underserved racial and ethnic groups, trial enrollment continues to be negatively affected by a lack of awareness, fear, and general mistrust, Murphy said, with historical and cultural factors also coming into play.
Chazan likewise cited a general lack of knowledge about clinical trials as a major barrier to participation. “In addition, fear of the unknown can paralyze patients, making them hesitant to take part in studies,” he said, stressing the importance of education during the trial recruitment process.
Also a factor, is socioeconomic status. Chazan said, “For those working hourly jobs, taking time off work to participate in a study can present a financial hardship. Stipends for participation don’t always cover all related expenses, such as travel to trial sites.”
Murphy echoed Chazan’s comment, noting that these obstacles “simply may not make clinical trials accessible to those of different socioeconomic levels.”
Despite these challenges, however, diversity is essential. “A medical treatment that is effective for one ethnic group may not have the same effects on another group,” said Murphy. “By conducting clinical research among genetically diverse populations, we gain critical insight and confidence into the safety and efficacy of the drug across all patient populations who will be using the drug if approved.”