Failure in randomization [Study As­sess­ment]

posted by Helmut Homepage – Vienna, Austria, 2019-04-19 12:07 (552 d 09:59 ago) – Posting: # 20193
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Hi libaiyi,

» In a 2*2 BE study, if subject A with planned sequence T-R is assigned to R-T and B with planned R-T has the actual sequence of T-R, what code can we use for the model statement with these two subjects included for a sensitivity analysis?

Is this related to this post of yours? That’s not a statistical issue but a serious violation of GCP. Of course, you could use the actual sequences in a sensitivity analysis. Even if both the per-protocol analysis and the sensitivity analysis pass, it would rise serious doubts about the procedures of the CRO. There were too many cases in the past (see this post) which would – rightly – set any assessor’s alarm bells off and likely trigger an inspection. Get prepared.

I faced not following the randomization once. The CRO ignored the randomization provided by the sponsor (well, claimed that it never was received) and used their own. How stupid is this? If the CRO really didn’t receive it in a timely manner, why not simply pick up the phone and sort it out with the sponsor? However, I got the randomization from the sponsor, study passed, statistical report (PK part) final.
I was also responsible to evaluate the safety part. When I got the CRFs from the CRO I realized that the drug administration didn’t match the randomization I had. F**k! Sensitivity analysis with the “true” randomization as an amendment to the statistical report. Study passed.
However, after some legal to and fro the CRO repeated the study at its own cost and never was contracted by the sponsor again.

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Helmut Schütz
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