1 / 3

E5 GL evolves from a Conjecture (or a grand excuse) to a Solid Ground

E5 GL evolves from a Conjecture (or a grand excuse) to a Solid Ground. E5 guideline is something like a conjecture that has not been proved yet. I am sincerely grateful to those who made the first “let’s sink or swim” decision, based on their expertise. Must be carefully applied.

jasper
Télécharger la présentation

E5 GL evolves from a Conjecture (or a grand excuse) to a Solid Ground

An Image/Link below is provided (as is) to download presentation Download Policy: Content on the Website is provided to you AS IS for your information and personal use and may not be sold / licensed / shared on other websites without getting consent from its author. Content is provided to you AS IS for your information and personal use only. Download presentation by click this link. While downloading, if for some reason you are not able to download a presentation, the publisher may have deleted the file from their server. During download, if you can't get a presentation, the file might be deleted by the publisher.

E N D

Presentation Transcript

  1. E5 GL evolves from a Conjecture (or a grand excuse) to a Solid Ground • E5 guideline is something like a conjecture that has not been proved yet. • I am sincerely grateful to those who made the first “let’s sink or swim” decision, based on their expertise. • Must be carefully applied. • It does evolve, however, with experiences, as mentioned in E5 GL itself. • Making it to a solid ground is our real goal. Kitasato-Harvard 2002 S ONO

  2. Drugs approved in Japan based on the “E5 conjecture” • 1999: 2 / 39 NCEs approved • 2000: 3 / 39 NCEs approved • 2001: 5 / 23 NCEs approved • It is these drugs that will establish the scientific authenticity of E5 guideline. • Real-world constatation has just started. Kitasato-Harvard 2002 S ONO

  3. Public Health is THE concern for the regulators. • Public health is not A concern; it is THE concern for regulatory people fueled by taxpayers’ money. • If their conservativeness ‘truly’ came from such concern, who can blame them? (Unrealistic assumption?) • Efficiency on producer’s (ie, investigators, industry) side does not necessarily guarantee efficiency in society; consumers (ie, regulators, practitioners, patients) have their say. (as long as economists at Harvard School of Public Health taught me right....) Kitasato-Harvard 2002 S ONO

More Related