Bioequivalence and Bioavailability Forum

Futility rule? [Study As­sess­ment]

posted by Helmut  – Vienna, Austria, 2013-07-29 14:16 (4362 d 16:00 ago) – Posting: # 11101
Views: 20,971

Hi ElMaestro,

❝ I think this is extremely interesting:

PEs of fed study:  pilot  pivotal
Ln(AUCINF_obs)     87.39   96.45
Ln(AUClast)        81.09   95.94
Ln(Cmax)           87.07   87.91

Extremely interesting indeed because Sam wrote in his original post:

❝ […] data for the Fed study ratio is totally replica of the Pilot Fed study

And later

❝ […] Pivotal PE of the Fed study is same as that of the Pilot

And again

❝ […] Fed pilot […] ratios of all the three parameters were same as per the pivotal study

Same? Would you buy such a Bangkok Rolex-replica?*

❝ […] This story could perhaps exemplify why a two-stage trial with a stopping criterion would have been a potentially interesting alternative.

Can you elaborate? I think it was very courageous (pun!) to proceed with a PE of 81% for AUC_t to a pivotal study.

❝ 1. How did you transit from the pilot trial to the pivotal?

As Sam said:

❝ We were very happy when our Fed study meets the BE criteria.

With no dropouts and PE/CV from the pilot “carved in stone” I would expect power of 8.2% [sic] in 48 subjects. That’s slightly lower than walking into a casino and go for a street in roulette (chances on a French table 1/11 ~9.1%). No surprise everybody was very happy when the pivotal study passed in 43 subjects.

❝ […] garnished with a classical Hötzi rant,

---

• Wer einmal lügt, dem glaubt man nicht. (German proverb)

—
Dif-tor heh smusma 🖖🏼 Довге життя Україна! 
Helmut Schütz


The quality of responses received is directly proportional to the quality of the question asked. 🚮
Science Quotes

Complete thread:

• Regulatory Query for study repeat sam 2013-07-27 07:50 
  • Repeats ElMaestro 2013-07-27 11:01
    • Repeats sam 2013-07-27 11:18
      • Repeats ElMaestro 2013-07-27 11:31
        • Repeats sam 2013-07-27 11:57
          • Repeats ElMaestro 2013-07-27 12:27
            • Repeats sam 2013-07-27 12:45
          • Bad science Helmut 2013-07-27 14:15
            • Bad science sam 2013-07-28 09:05
              • Posting style & incomplete information Helmut 2013-07-28 12:32
                • Posting style & incomplete information sam 2013-07-29 06:46
                  • RTFM! Helmut 2013-07-29 07:53
                    • RTFM! sam 2013-07-29 08:40
                      • copy & paste error or what? Helmut 2013-07-29 11:14
                        • copy & paste error or what? sam 2013-07-29 12:46
                    • Calm down! jag009 2013-07-29 16:06
                  • Slightly off-topic: The wonders of pilot trials ElMaestro 2013-07-29 09:19
                    • Futility rule?Helmut 2013-07-29 12:16
                      • Futility rule? ElMaestro 2013-07-29 12:46
                    • Slightly off-topic: The wonders of pilot trials sam 2013-07-29 12:41
                      • PE of AUC? Helmut 2013-07-29 12:45
                        • PE of AUC? sam 2013-07-29 12:56
                          • EOD Helmut 2013-07-29 13:18
                  • Posting style & incomplete information jag009 2013-07-29 16:32
                    • Posting style & incomplete information sam 2013-07-30 06:08
              • Bad science ElMaestro 2013-07-28 12:43
        • Repeats jag009 2013-07-27 22:17
          • Repeats ElMaestro 2013-07-27 23:11
  • Regulatory Query for study repeat jag009 2013-07-27 22:29
    • Regulatory Query for study repeat sam 2013-07-29 12:36
      • Regulatory Query for study repeat luvblooms 2013-07-30 08:28
        • More questions.. jag009 2013-07-30 16:53