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.