4 ms·
No. The effect size was large enough that the statistical significance agreed with the FDA before the start of the study was reached well before the end of the
by Mvandenbergh 14y ago
No. The effect size was large enough that the statistical significance agreed with the FDA before the start of the study was reached well before the end of the trial. This is not uncommon, and the possibility of ending the trial early will have been decided beforehand. Usually an independent advisory board not affiliated with the FDA or the pharma company will make these decisions - the other parties may not even have known that the results were better than expected until the independent board decided to end the study.