Given that the p-value in the entire study population exceeded 0.05, the statistical analysis plan
for the study required the p-value in the high subset to be less than or equal to 0.025 to achieve statistical significance.
All data analyses performed were pre-planned and specified in the statistical analysis plan
The statistical analysis plan
for the TRCA-301E trial also specified a comparison of the TRC101 and placebo groups for the time to the composite clinical endpoint of death, dialysis/kidney transplant or a greater than or equal to50% decline in estimated glomerular filtration rate over the combined 52-week treatment period.
The design of the head-to-head study and statistical analysis plan
included prespecified and controlled for multiple testing for both non-inferiority and superiority of baricitinib compared with adalimumab.
Fibrocell plans to submit a revised clinical trial protocol and statistical analysis plan
based upon the FDA's feedback and requested chemistry, manufacturing and controls, or CMC, information to the investigational new drug, or IND, application.
Ventrus' development partner, SLA Pharma, has completed the majority of the outputs for the statistical analysis plan
of the Phase 3 trial, and the company is now able to communicate the data that it has generated.
He believes the FDA is now in complete agreement with the NASH protocol, "after approving a more complete statistical analysis plan
that better accounts for the seamless trial design of transitioning from the pivotal Phase 3 into the post-marketing Phase 4 study." Arce keeps a Buy rating on Madrigal.
Based upon additional analysis of prior trial data, as well as input from a panel of clinical experts assembled by AspenBio's regulatory consultants, the Statistical Analysis Plan
(SAP) for this supplemental trial has now been finalised.
Importantly, the study also achieved statistical significance for relevant additional endpoints pre-specified in the statistical analysis plan
to better characterize the clinical benefit of the opioid reduction, including: total opioid consumption at one and two weeks following C-section and percentage of opioid-spared patients, a composite endpoint, which was defined as patients who took no more than one oxycodone 10 mg tablet and graded their bother or stress from the following opioid-related adverse events as "not at all": vomiting, itching, sweating, freezing, or dizziness.
The FDA-approved statistical analysis plan
was designed with an interim blinded analysis to provide a safeguard for the assumptions used in the design of the protocol.
The interim analysis was conducted in accordance with a revised statistical analysis plan
using an Intent to Treat analysis of a partial cohort of all implanted subjects that have reached their six-month post-implant time point.
The upcoming stages include finalizing the Statistical Analysis Plan
, conducting the final data collection, data validation and data lock, and then unblinding and analyzing the data."