The pharmaceutical, biotech and medical device industries are facing a list of unprecedented challenges led by the global economic crisis and concerns about escalating healthcare costs. A series of well-publicized recalls and regulatory settlements have left policymakers and consumers questioning the safety of medical products and their trust in manufacturers. Related to all of this is the emerging challenge of obtaining product reimbursement. Payers increasingly demand that all new medicines and technologies provide evidence of value — clinical and economic — to secure reimbursement and market access.

With a consolidating payer base increasingly driving healthcare decision-making, there appears to be a growing trend to require more evidence than that offered by randomized clinical trials (RCTs) — the familiar “gold standard”. Real-world evidence (RWE) is gaining legitimacy as an element of the research agenda, and as an important tool to pick up on potential adverse events and applications that might otherwise go unnoticed because of the nature of RCTs.