Regulatory
Industry professionals can look to the FDA’s guidance, alongside work already being done in the research sector, to understand what practical steps they can take to improve diversity within their own trials.
Broaden the criteria
The experience of disease can be influenced by a range of different factors, from socio-economic status to culture, through to lifestyle and genetics. When developing eligibility criteria that would best reflect the patients likely to take a drug, it follows that researchers should consider this broader picture of who they are and what their lives look like. While there isn’t clear guidance or established protocols for doing so yet, Jennifer Harris, head of research policy at the Association of the British Pharmaceutical Industry (ABPI), recommends starting with the disease area and developing an understanding of how it is experienced by different groups of patients. “You need to really understand the disease and you really need to understand where the patients are,” she says. “What we’d like to see is for the whole trial to have that representative group of patients relative to what’s necessary for that disease area.” Here, engaging with patients from the start of the trial is key. “That will help you make sure that you’re defining the unmet need properly,” adds Harris. The FDA’s guidance notes that enrolling a diverse study population may require consideration of both demographic and non-demographic characteristics, but has no current plans to issue further regulations that require reporting of trial participant data beyond race, gender and age, says FDA spokesperson Chanapa Tantibanchacha. However, there is still work to do in improving diversity across these three demographic factors. “Sometimes certain populations are excluded from trials without strong clinical or scientific justification,” says Tantibanchacha, giving the examples of older adults, those at extremes of the weight range, those with HIV and children. The FDA recognises that exclusion of these groups has simply become accepted over time or even used as a template for eligibility across trials. Researchers should think critically about why they would exclude a certain group and whether they can justify that decision. Other groups that have historically been excluded from clinical trials are women, gender diverse and non-conforming individuals, and people of colour.
Avoid bias in trial design
From selecting a patient population to defining trial outcomes, there are various ways that bias in clinical trial design can work against diversity. For Harris, avoiding bias in trial design is fundamentally a
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question of patient involvement. Including the patient voice from the start of the process can not only ensure that the trial is focused around end points that matter to that patient population, but also that it is designed in a way that makes it possible for them to participate. “We’ve had some examples of incidences where the primary end point for the trial has been this thing there but, actually, what matters to the patient more is this thing over there,” she says. “By actually working with patients, companies have then been able to work with regulators as well and say, we need to kind of revise what matters here. That trial then becomes a lot more representative of what the patient wants it to be and needs it to be.” This echoes FDA guidance to incorporate patient- focused research into clinical trial design, which can help stakeholders to understand participant needs but also any challenges or burdens that may prevent them from enrolling. Any necessary accommodations, such as childcare facilities or planning around a patient’s work schedule, could then be accounted for.
Up until recently, clinical trials for most drugs in use were almost exclusively trialled on men.
“You need to really understand the disease, and you really need to understand where the patients are.”
Jennifer Harris, Association of the British Pharmaceutical Industry
For sites, an important step in preventing bias is recognising where it could occur. In October 2020, the Society for Clinical Research Sites (SCRS) launched the SCRS Diversity Site Assessment Tool (DSAT) to help sites assess their progress in recruiting and retaining diverse patient populations. Sites can use this tool to identify how inclusive and accessible a trial is, for example, whether there is an adequate understanding of the trial participants’ demographics, and then create a plan to improve where necessary. A common theme in areas the tool identifies is having a good understanding of the target group –
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