WISDOM Project

Status: Active

Adaptive Biomedical Innovation (ABI) requires that there be a more seamless knowledge continuum spanning the pre/post market phases of product innovation.

Evidence generated from data sources beyond traditional Randomized Clinical Trials (RCT) is becoming increasingly important in biomedical innovation in the era of precision medicine and value-based reimbursement models. While there is much excitement about the increasing availability of “big data,” our ability to deliver meaningful patient value from it so far remains elusive. Shifting our focus from inputs to outcomes requires that we better understand the requirements for actionable evidence as defined by key decision-makers (regulators, payers, providers, and patients). In other words, the new evidence must be ‘fit for purpose’ as determined by stakeholders upon whose actions innovation success will depend.

The NEWDIGS WISDOM Project seeks to describe and demonstrate how new kinds of evidence integrated with that from traditional RCTs could impact (1) specific decisions regarding biomedical innovation marketing authorization, access and use, and (2) outcome metrics that are meaningful to each stakeholder.