When the AC panelists were asked if the trial results establish that the product is efficacious, it was obvious they were all struggling with the wording of the question. Specifically the word "establish" was mentioned repeatedly. So I looked up the definition of the word, of which one is: to put beyond doubt, to prove.
Obviously many drugs have been approved that didn't meet the requiremints of this question as presented.
So, I decided to see how the question was presented to others. This led me to this page on the NCI website:
Understanding the Approval Process for New Cancer Treatments
As the FDA looks at all the data submitted and the results of its own review, it applies two benchmark questions to each application:
- Do the results of well-controlled studies provide substantial evidence of the treatment's effectiveness?
- Do the results show the product is safe under the conditions of use in the proposed labeling? In this context, "safe" means that potential benefits have been determined to outweigh any risks.
What immediatly becomes apparent is the first question asked to our panel was not the standard FDA wording. The re-worded question was the one that should have been asked in the first place.