Disease area is not well defined

The disease/indication may have an imprecise definition, and so there may be no well-established criteria for defining the population of interest (likely to receive the new intervention). A clinical code (ICD or other) may not yet have been established for the disease entity. Correspondingly there may be a lack of clinical guidelines, and usual care (or standard of care) may not be well established for the target population within an agreed treatment pathway. This may lead to uncertainty in applying trial results to the local context, as well as subsequent difficulties in setting up studies to monitor the usage and effectiveness of the medicine post-launch.