Is it acceptable to develop new or to revise existing study hypotheses as the study progresses?
We generally believe it would be inappropriate to draw conclusions from after-the-fact hypotheses. We recommend that changes in study protocols be carefully documented and explained. FDA encourages sponsors to contact the appropriate review division to discuss studies before they are initiated and that FDA be consulted when changes in protocols are made mid-study. (For the FDA divisions responsible for review of IVD products, s ee Introduction, Section II, of this guidance.
