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The Heart of the Matter 7: Reality Dawns

The heart of the matterThe drivers, benefits and value of RWE are now unquestionable. From a regulatory perspective, the Food and Drug Administration (FDA) has been requesting more post-authorisation studies to monitor what happens with drugs in real-world settings since the FDA Amendments Act (FDAAA) was signed into law in 2007 clarifying the FDA’s authority to require and enforce Risk Evaluation and Mitigation Strategies or REMS programmes. Likewise, European pharmacovigilance legislation implemented in 2012 means the European Medicines Agency (EMA) is now requesting post-marketing observational studies as part of its approval processes. In tandem, as the limitations of the ‘gold-standard’ randomised clinical trial (RCT) data are increasingly exposed, European initiatives such as the Innovative Medicines Initiative’s GetReal and ADAPT-SMART underline how governments and regulators are striving for consensus on the use of observational research and iterative evidence generation that may result in patients gaining faster access to novel therapies.

As patient-centricity becomes embedded as a key priority for payers and providers, greater emphasis is being placed on real-world data and how it can be used to measure clinical outcomes and healthcare expenditure. In response, biotech and pharma companies are focused on developing data-led value propositions to generate evidence of budget impact, burden of illness, disease prevalence, treatment patterns, treatment response, comparative effectiveness and patient-reported outcomes. These are the preserve of RWE and their ‘real-world’ value is now indisputable.

In simple terms, the global need for effectiveness data to support brands’ value propositions is writing a cheque that RCTs alone cannot cash. RWE has therefore become more than just a zeitgeist for pharmaceutical strategists – it’s an essential ingredient in their success.

Read: The heart of the matter

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Conversis Medical is a translation company specialising in translation and localisation for the medical industry, particularly in clinical trial projects....

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