Table 1

Criteria for determining clinical usefulness and nature of pharmaceutical innovation, adapted from Aronson et al1 and Ferner et al10

Embedded Image
  • *Assumes a favourable benefit to harm balance in key patient-related outcomes (health-related quality of life and/or survival). Criteria taken from Aronson et al1 and Ferner et al,10 however Aronson also included a fifth category, ‘more cost-effective treatment’, but this was not assessed as part of this study.

  • †Ranked order, with higher categories potentially also including elements of lower ranked categories.

  • ‡Aronson et al1 and Ferner et al10 also considered the novel application of an existing compound as highly innovative, but such examples were not included in this study (which was restricted to new drugs).

  • §Taken from Aronson et al1 and Ferner et al.10 Failed examples are also given in Ferner et al.10

  • ¶Modified-release formulations might be moderately innovative if, for example, they reduced the risk of adverse reactions or drug–drug interactions.