Manual for Real World Evidence Development - Health Technology Innovation Platform - Overview Contents

By several steps that guide users through the following the steps outlined in the manual, development of a complete RWE development stakeholders can generate decision-grade evidence to program, starting with the identification of key support transparent and informed decision-making as knowledge gaps, the construction of evidence maps, innovative new products transition from the lab to and the use. [...] The aim is to evaluate the risk the effective planning and generation of RWE to that each evidence gap may impact decision-making support decision-making from the early stages of during the product's lifecycle. [...] pathways, conducting horizon scans for potential Serving as an anchoring framework, the manual competitors, constructing evidence maps, and provides a detailed set of steps and guidance for the identifying gaps that the clinical development plan development of a prospective and integrated RWE has not addressed. [...] establishing optimal study sizes, and identifying the The manual covers the design and implementation of best value evidence development strategy for each evidence development activities, emphasizing the evidence gap. [...] This stage also later stage decision making such as clinical covers the creation of the RWE development program recommendations, coverage decisions, and other and the design of conditional reimbursement health system and public health recommendations.