Choosing the best approach to generate data required will be influenced by a range of factors including budget, timescale, existing data, market setting and stakeholder support.
Randomised controlled trials and other traditional studies of this nature remain critical in providing the initial data backbone. They provide a robust output which is recognised accordingly within the evidence grading hierarchy. However, these approaches are usually slow, resource-intensive and can be difficult to apply across multiple geographies with nuanced data requirements.
Other, more flexible solutions are needed to fill key gaps more rapidly or to provide greater localisation and market-specific focus, especially as time on the market evolves.