SMA
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Europe,
2023-05-24 10:37
(424 d 01:47 ago)

Posting: # 23565
Views: 1,805
 

 ICH E6(R3) draft Guideline reaches Step 2 of the ICH process [BE/BA News]

The ICH E6(R3) draft Guideline on “Good Clinical Practice (GCP)” has reached Step 2 of the ICH process on 19 May 2023.
The E6(R3) draft Guideline and guidance for stakeholder public consultation comment collection are available for download on the E6(R3) page.
The guideline is composed of principles and annexes that expand on the principles with specific details for different types of clinical trials.
The guideline applies to interventional clinical trials of investigational products that are intended to be submitted to regulatory authorities and may also be applicable to other interventional clinical trials of investigational products that are not intended to support marketing authorisation applications in accordance with local requirements.
Annex 1 which is included in this Step 2 document is intended to provide information on how the concepts can be appropriately applied to clinical trials.
Work on Annex 2, regarding additional considerations for interventional clinical trials, has just been initiated, with an Annex 2 Concept Paper approved in May 2023 by the ICH Management Committee.

Regional consultations will follow for those interested in providing comments.
Helmut
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Vienna, Austria,
2023-05-29 10:34
(419 d 01:50 ago)

@ SMA
Posting: # 23575
Views: 1,403
 

 Validation of sample size esti­ma­tions?

Hi SMA,

THX for posting!

An interesting statement in 3.16.2 Statistical Programming and Data Analysis:
  1. The sponsor should ensure that appropriate and documented quality control of statistical programming and data analysis is implemented (e.g., for sample size calculations, …).
This would be a tough cookie in connection with 4.5 Validation of Computerised Systems.

Good luck! For parallel groups, 2×2×2 cross-overs, and RSABE/ABEL sample size tables were published. Regrettably some contain typos or the number of simulations for RSABE/ABEL was too small for a stable result (see this article). You are left out in the rain if you want anything not covered (say, power 85% and/or a T/R-ratio of 0.93). AFAIK, nothing is published for Higher-Order crossovers, Balaam’s design, ABE in replicate designs, the FDA’s ref­er­ence-scaling for NTIDs, and Non-Inferiority / Non-Superiority. IMHO, the only solution would be to get yet another software and perform cross-validation.

Of course, requiring software validation in general is not new. Don’t trust the vendor. Validation always lies in the hand of the user.1–3


  1. ICH. Statistical Principles for Clinical Trials. E9. 5 February 1998. Section 5.8.
  2. FDA. Statistical Software Clarifying Statement. May 6, 2015. Download.
  3. WHO. Guidance for organizations performing in vivo bioequivalence studies. Geneva. May 2016. Technical Report Series No. 996, Annex 9. Section 4.4. Online.

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