Health research bias a risk to safe and effective treatments, say researchers

In a new report on diversity and dementia (16-page / 2.7MB PDF), the DRI called on health researchers to “innovate in the name of inclusivity”.

Publication of the DRI report follows calls by Pinsent Masons for diversity requirements to be imposed on researchers developing new medical technologies. In a recent article, life sciences expert Helen Cline of Pinsent Masons said that imposing diversity requirements would improve health outcomes for all groups in society and could even save lives.

In its report, the DRI highlighted how a “lack of diversity has been acknowledged to lead to translational failure when it comes to drug development” for Alzheimer’s disease. It said women have often been underrepresented in clinical trials for new medicines to treat the disease.

However, its report also alluded to a lack of diversity being a problem across much wider health research too, citing the historical underrepresentation of people from minority ethnic backgrounds in clinical trials for new medicines.

“To produce generalisable results – and avoid approving drugs that are less effective or less safe in certain populations – trial participants must be representative,” it said.

“People may be prevented from participating in clinical trials for a number of reasons, including lack of information, lack of trust, limitations on resources, pragmatic barriers such as the requirement to travel or give up time, or because they do not meet strict inclusion criteria built into the study design,” the DRI said. “This creates a gap in knowledge about the groups who are excluded, which in turn perpetuates health inequity.”

The DRI said its researchers are “working to address challenges of trial design, resources, trust, information and geographical distance” to ensure that clinical trials undertaken in the name of dementia research are more accessible.

“What we really need in dementia is new treatments, and we need to be sure that those treatments will help those who need them most,” the DRI said. “We also need to understand what puts certain groups at higher risk, and how best to prevent disease. To achieve that, we need to go right back to the science itself. We need to understand how and why different groups are affected differently by the same diseases, so that we can target interventions where they are most needed and maximise their benefit. We must reject longstanding biases in scientific research, and instead innovate in the name of inclusivity.”

“Just as biological disease pathways differ between populations, we cannot assume that all groups will respond similarly to a particular drug,” the DRI said. “… we need to understand the nuances of the biological pathways of disease in different groups, and build diversity into our science from the beginning.”

“At the UK Dementia Research Institute (UK DRI), it is our policy that both sexes should be used in all pre-clinical work – including mouse models and cell lines – and that the sexes should be balanced. This must always be the case unless there is a compelling reason to include only one sex (e.g. studying a genetic form of disease that is linked to the X or Y chromosome),” it said.