According to NDA Group scientific director, Markku Toivonen, patient engagement – which covers patient-centric approaches to pharmaceutical R&D and patient-derived outcomes – is attracting increased attention in the drug development landscape.
“Patient engagement is everywhere. It has been adopted by both big pharma and smaller companies,” Toivonen told delegates at Nordic Life Science Days last month.
And while implementing patient-centric strategies throughout the development stage can cost time, money and planning, according to Toivonen, it ‘pays off’ in the long-term.
“It is a de-risking exercise, particularly in rare conditions where…clinical data will help you understand which patient-reported outcomes should be taken to confirmatory trials,” he said, adding that understanding the clinical relevance of a treatment’s effect can be one of the “main stumbling blocks” for new drug applications.
“If you have relevant endpoints measuring…the subject’s benefits, you are much better off.”
Looking ahead
According to Toivonen, in the future, patient-reported outcomes – designed to reflect benefits truly perceived by patients – will carry more weight in regulatory reviews and “take a major role in health technology assessment”.
However, pharmaceutical companies must take responsibility, and act now, he told delegates. “I want to emphasise: Do not leave patient engagement only to the regulators…or their public advisory boards.”
