let me see if my post goes through:
What is your take on AF negative comments below:
"After initial locking of the database for KODIAC-05, data associated with one patient that was previously assessed as non-retrievable was found to be retrievable. These data were added to the database and the database was again locked and underwent a final analysis.
Once a clinical trial database is locked, it needs to stay locked. Locking and unlocking a database raises the risk that data can be improperly altered or manipulated. AstraZeneca insists proper procedures were followed and the naloxegol analysis presented Monday is accurate. But it's also plausible to believe AstraZeneca found no statistically significant difference in response rates between naloxegol at either the 12.5 mg or 25 mg dose compared to placebo. [AstraZeneca admits the 12.5 mg dose of naloxegol showed no benefit.]
Faced with a failed phase III trial of its critically important opioid constipation drug, AstraZeneca may have embarked on a hunt to retrieve additional data from the "non-retrievable" patient. "Retrieved" data found. Database unlocked. "Retrieved" data added. Database locked a second time. Trial analyzed (again.) Winner!
Before you ask, yes, data from a single patient can make a difference in the outcome of KODIAC-05 trial. Look at the results announced Monday: The 12.5 mg dose of naloxegol failed badly with a p value of 0.202 while the 25 mg dose barely squeaked into victory lane with a p value of 0.021. [The trial required a p value less than 0.025 to reach statistical significance.]"