Real-world data – optimising your strategy for market access success
As greater emphasis is placed on real-world data to support therapies’ value, it is increasingly important to source and manage data from disparate sources. Evidera’s Dimitra Lambrelli and Krista A Payne outline the points to consider in preparing an effective data strategy in their feature article in Deep Dive: Market Access II.
The early delineation of key value messages and associated evidence requirements, alongside a structured review of existing clinical trial and real-world data gaps, are critical first steps for successful market access. This stepwise evidence generation planning process serves to both identify and prioritise the research activities of importance – including the determination of real-world data needs. Questions related to ‘which data’ from ‘which sources’ and ‘what methodology’ to address priority research objectives are at the core of a tailored, fit-for-purpose data strategy.
The identification of optimal data sources, and deriving meaningful outcomes, amidst the chaos of masses of fragmented snapshots of patient experiences accruing daily, is a complex exercise.
Points covered in the article include:
- The generation and strategic use of RWE is crucial in acquiring and defending optimal payer positioning of your product.
- Although they are the gold standard for assessments of efficacy, randomised controlled trials do not provide information about a drug’s real-world value, safety or effectiveness.
- The systematic appraisal of potential secondary data sources and the delineation of real-world data gaps and potential biases should be undertaken as early as possible and should be a pre-requisite to a comprehensive evidence generation plan.
Read more in the full article here.
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