WHO Trial Guidance Goes Beyond Race and Gender When Tackling Diversity

eClinical Solutions senior director Jason Housley said that sponsors are almost fearful of how data may be interpreted by the FDA if it is potentially perceived as ‘inadequate’ which is halting innovation when it comes to patient populations in studies.

“There are a multitude of examples of this ‘transformation-killer’,” Housley explains. He adds that this concern by regulators can be around patient population selection, the collection of “interesting or niche” data; and data validation.

“Still the industry takes a belt-n’-braces approach due to the perceived risks around inadequate quality. All this despite multiple regulatory papers encouraging risk-based approaches,” Housley concludes.