Rethinking first principles
Back to School Part 4: Digital health will call for a new set of first principles for clinical development
Stakeholders will need to draft a new set of first principles to inform the rules of the road for digital health, because many of the traditional elements of clinical development may not have meaning. Drug developers, regulators and payers will need to continually re-examine the foundations underlying validation, efficacy and outcomes.
Succeeding in digital health will mean being prepared to abandon some deeply embedded concepts, and creatively bridging from analog paradigms that have been the basis of drug development and reimbursement...