calculation of 90% CI for continuous variable in clinical endpoint studies [General Sta­tis­tics]

posted by GM – India, 2017-11-21 07:02 (2025 d 02:32 ago) – Posting: # 17995
Views: 4,486

Hello El-Maestro,

Sorry I am understanding the guidance (see Clindamycin OGD)wrongly, as I already told "am new to endpoint studies".

As per the OGD section #6, the primary end point is, Percent change from baseline to week 12 in the inflammatory (papules and pustules) lesion count.

As per the OGD section #20, Equivalence Analysis

The compound hypothesis to be tested is:
H0: µT / µR ≤ θ1 or µT / µR ≥ θ2 versus HA : θ1 < µT / µR < θ2

Where µT = mean of test treatment, and µR = mean of reference treatment
Typically, we reject H0 with a type I error α = 0.05 (two 1-sided tests), if the 90% confidence interval for the ratio of means between test and reference products (µT / µR) is contained within the interval [θ1, θ2], where θ1 = 0.80 and θ2 = 1.25.

Here as per my understanding, the primary endpoint is untransformed data. That's why I had this confusion:confused:. and why 90% CI interval given as 00.80-1.25?

if the primary endpoint is ln-transformed data then there is no problem to calculate ratio of means or difference of means as you said earlier.

Sorry if I am confusing everybody. Kindly give me some idea on this.

Thanks in advance,

Best Regards,

Complete thread:

UA Flag
 Admin contact
22,620 posts in 4,741 threads, 1,612 registered users;
20 visitors (0 registered, 20 guests [including 9 identified bots]).
Forum time: 10:34 CEST (Europe/Vienna)

Outside his own ever-narrowing field of specialization,
a scientist is a layman.
What members of an academy of science have in common
is a certain form of semiparasitic living.    Erwin Chargaff

The Bioequivalence and Bioavailability Forum is hosted by
BEBAC Ing. Helmut Schütz