In a block randomisation clinical study, the block length was 10 which was decided and known only by the biostatician. Random allocation sequence was done with a computerized random-number generator. The allocation numbers were random four-digit numbers which were in non-consecutive order in the allocation list.
Question - If the biostatician is aware of the block length, is this of any significance? Does it bring in any bias?
No, there is no impact on the study if the biostatician is aware of the block length as he has no impact on patient selection, ramdomisation of single patients and treatment.
As a team member has to decide on the block length, the biostatician is a good choice. But even if the project manager decides (and therefore knows, it has no impact. Only the study site team (and best case the monitor) should not know.
I'm agree with Dr Peter sedlace. That there is no impact on the study if the biostatician is aware of the block length as he has no impact on patient selection, ramdomisation of single patients and treatment.
The more important is to conceal random sequence away from main invisitgators.
Yes, Dr Peter and A Alqutaibi both have correctly said as concealment applies to the site Principal Investigators and Co-Investigators as well as the Monitor for a correctly conducted clinical trial.
Thank you all for sharing your thoughts on this. This is indeed very useful.
PS: Apologies for the delayed response, was working on an assignment (with tight deadlines) back then when I had posted the question.
Kind Regards, Kanchan
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