Bioequivalence and Bioavailability Forum

Pilot or pivotal ? [General Sta­tis­tics]

posted by ElMaestro  – Denmark, 2018-06-27 15:01 (2120 d 04:42 ago) – Posting: # 18977
Views: 12,704

Hello Ohlbe

❝ Isn't the common practice to first test T1 and T2 vs. R in a pilot study (and I will not get into a debate on whether alpha correction would be needed), select one of the two test formulations, and then test it in a pivotal study in the usual way ? How often do you see both test formulations directly tested in a pivotal study ?

That's right. I have never seen an evaluation of two tests in a single study in which the applicant hoped for approval of both.

❝ OK, maybe if the product has a very low variability and the number of subjects remains very low, it could make sense and save time to directly go for the pivotal. Any experience ?

Yes absolutely. The majority of dossiers are being accepted without pilot trials. Whether to go for a pilot before a pivotal is dictated by many factors. First to file is a very significant one, but also involved is BCS class, budgets, previous failures ("You guys need to start showing some results!"), gut feeling and much more.
However I get slightly worried when you are suddenly allowing the term sense to enter this discussion. My empirical observation is that that term has absolutely no place in the planning of BE studies.

Complete thread:

• Decision of confidence interval of three period BE study libaiyi 2018-06-26 12:00 
  • Two tests and one reference Helmut 2018-06-26 13:13
    • Two tests and one reference Brus 2020-08-31 09:58
      • Two tests and one reference ElMaestro 2020-08-31 10:23
      • Two regions: No α adjustment Helmut 2020-08-31 10:26
        • Two regions: No α adjustment Brus 2020-08-31 11:09
          • Two regions: different populations Helmut 2020-08-31 11:26
  • Decision of confidence interval of three period BE study ElMaestro 2018-06-26 22:20
    • Any of two tests and one reference Helmut 2018-06-27 00:33
      • Any of two tests and one reference libaiyi 2018-06-27 08:25
      • Hey wait a moment.... ElMaestro 2018-06-27 08:29
        • Hey wait a moment.... Helmut 2018-06-27 11:45
          • Pilot or pivotal ? Ohlbe 2018-06-27 12:14
            • Pilot or pivotal ?ElMaestro 2018-06-27 13:01
              • Pilot or pivotal ? Ohlbe 2018-06-27 14:13
                • Pilot or pivotal ? ElMaestro 2018-06-27 14:48
                  • Pilot or pivotal ? Ohlbe 2018-06-27 15:43
                    • Pilot or pivotal ? ElMaestro 2018-06-27 22:13
            • Pilot or pivotal ? jag009 2018-06-29 20:53
              • Pilot or pivotal ? ElMaestro 2018-06-29 22:11
                • Pilot or pivotal ? jag009 2018-07-03 17:38
          • Hey, hey wait another moment.... d_labes 2018-06-28 19:48
            • Hey, hey wait another moment.... Helmut 2018-07-03 17:22
              • Old belives die hard d_labes 2018-07-04 13:28