Sereng
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USA,
2023-02-08 19:23
(474 d 00:00 ago)

Posting: # 23447
Views: 2,755
 

 Are Statistical Analysis Plans “required” for Pivotal Studies? [General Sta­tis­tics]

Dear colleagues, we are conducting a pivotal fed-fasted BE study versus a reference listed drug (RLD). In this case, by "pivotal", I mean the study will serve as the sole basis for (US) NDA approval. My CRO states that no "standalone" Statistical Analysis Plan (SAP) is required and that the statistical analysis in the protocol should suffice. However, the information in the protocol does not capture everything I would ordinarily expect to be in the SAP and I am not comfortable with the CRO's response. Is a (detailed) SAP required (or recommended), particularly where the entire NDA will be predicated on its findings?

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Helmut
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Vienna, Austria,
2023-02-09 10:49
(473 d 08:35 ago)

@ Sereng
Posting: # 23448
Views: 2,197
 

 SAP vs. part of the clinical protocol

Hi Sereng,

❝ My CRO states that no "standalone" Statistical Analysis Plan (SAP) is required and that the statistical analysis in the protocol should suffice.


Why not? Was accepted in 400 of my studies. Then I opted for a separate SAP.

❝ However, the information in the protocol does not capture everything I would ordinarily expect to be in the SAP and I am not comfortable with the CRO's response.


What would you ordinarily expect?

❝ Is a (detailed) SAP required (or recommended), particularly where the entire NDA will be predicated on its findings?


No. However, whatever format is used (SAP or planned statistics as part of the clinical protocol) it must be detailed enough to enable assessors/inspectors to unambiguously reproduce results with given data.

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Sereng
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USA,
2023-02-11 00:34
(471 d 18:49 ago)

@ Helmut
Posting: # 23454
Views: 2,061
 

 SAP vs. part of the clinical protocol

Hi Helmut, I am not sure whether my reply should be at the top or bottom in this forum. Many thanks for your response. Do you include your BA/BE study SAP with you NDA? Regards

❝ […] whatever format is used (SAP or planned statistics as part of the clinical protocol) it must be detailed enough to enable assessors/inspectors to unambiguously reproduce results with given data.



Edit: Full quote removed. Please delete everything from the text of the original poster which is not necessary in understanding your answer; see also this post #5[Helmut]

Biostatistically Challenged CEO
Helmut
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Vienna, Austria,
2023-02-11 14:22
(471 d 05:02 ago)

@ Sereng
Posting: # 23455
Views: 2,123
 

 Traceability

Hi Sereng,

❝ Hi Helmut, I am not sure whether my reply should be at the top or bottom in this forum.

See here and there.

❝ Do you include your BA/BE study SAP with you NDA?

Whatever you planned must be included as appendices to the report. Only then your results are traceable from the raw data.

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Achievwin
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US,
2023-02-15 13:07
(467 d 06:16 ago)

@ Sereng
Posting: # 23467
Views: 1,925
 

 Are Statistical Analysis Plans “required” for Pivotal Studies?

❝ Dear colleagues, we are conducting a pivotal fed-fasted BE study versus a reference listed drug (RLD).


Here is my opinion:

Essentially it is your study and you have to defend the submission, it is your prerogative to have what you want. - CRO gets most of their money when they deliver draft report (study pass/fail)

If it is a complex study - you have to predefine critical steps in the SAP (before the sample analysis start- to avoid any claims of Bias).

If it is a study against the product specific guidance and logical analysis is easy to understand you can refer to the FDA guidance(s) in the protocol.
ElMaestro
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Denmark,
2023-02-16 07:55
(466 d 11:29 ago)

@ Sereng
Posting: # 23468
Views: 1,878
 

 Are Statistical Analysis Plans “required” for Pivotal Studies?

Hi Sereng,

to the best of my knowledge and experience, in practice no SAP is generally required but you are expected to have a description prior to reconciliation with the RC which describes everything you will do in sufficient detail that you do not have degrees of freedom after the point when the reconciliation is done.

It is not formulated this way in any guidance document.

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