Revalidate the study [Study As­sess­ment]

posted by ElMaestro  – Belgium?, 2014-07-20 20:04  – Posting: # 13277
Views: 4,520

(edited by ElMaestro on 2014-07-20 23:08)

Hi Ken Peh,

» We ran a BE study on 24 subjects. Unfortunately, on the day of study, two subjects dropped out and 7 subjects worked night shift and could only reported to the trial site after midnight. We were told that the 7 subjects could not be considered as these subjects could not be proven to have fasted. The study passed with 15 subjects and CVintrasubject of AUC and Cmax were below 10%.

Being lucky is not a crime.

» We were asked to revalidate the study since the power of study should be 24 subjects. How do we revalidate the study ? Can we use the posthoc CV to show that the power is more than 80% even with 15 subjects ?

I do not know what it means to revalidate a study. Probably someone has misunderstood something.
24 subjects dosed, 15 evaluated of which 7 are likely due to bad planning on your part. Fix it before doing further trials. Make sure to discuss night shifts etc with volunteers. You really do not wish to enroll people who are not available (willing to make themselves available) due to mundane issues such as work habits.
Anyways, the study passed the product is declared BE even with 15 volunteers. Well done. If anyone asks about power, they are wrong. But they could very justifiedly ask you to embark on preventive actions.

Consider: You roll a dice 9 times and get a total of 43 eyes. Afterwards you ask questions. What's the chance of this outcome? How can you get such an outcome when the dice is fair, can you revalidate the dice?

I could be wrong, but...
Best regards,
ElMaestro

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