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Register"obtain balanced groups" vs randomisation [BE/BA News]
Hi all,
This is a very tricky way to write something for clarification.
It is like they give you a choice - Do you want to randomise or do you want to "obtain balanced groups" ? On average (whatever the hell that means) plain randomisation assures balance, but randomisation does not in any individual case guarantee balance. Perhaps they meant to combine stratification with randomisation. Or what?
Had they written "it is extremely important to aim for balanced groups" then I'd get the point. But that would not change anything from today's practice, as all CRO's to the best of my knowledge are randomising.
What is it they really tried to clarify? And how do I do comply?
❝
- In case of a parallel design, it is extremely important to obtain balanced groups in all demographic characteristics that might impact the pharmacokinetics of the drugs. The methods employed to ensure balanced groups are generally not described in the protocols.
This is a very tricky way to write something for clarification.
It is like they give you a choice - Do you want to randomise or do you want to "obtain balanced groups" ? On average (whatever the hell that means) plain randomisation assures balance, but randomisation does not in any individual case guarantee balance. Perhaps they meant to combine stratification with randomisation. Or what?
Had they written "it is extremely important to aim for balanced groups" then I'd get the point. But that would not change anything from today's practice, as all CRO's to the best of my knowledge are randomising.
What is it they really tried to clarify? And how do I do comply?
—
Pass or fail!
ElMaestro
Pass or fail!
ElMaestro
Complete thread:
- WHO frequent deficiencies in protocols and reports Ohlbe 2020-12-04 12:04
![[Mix]](https://static.bebac.at/img/mix.png "open in Mix view")
- WHO frequent deficiencies in protocols and reports ElMaestro 2020-12-04 14:10
- CI inclusion ≠ TOST Helmut 2020-12-04 20:30
- CI inclusion ≠ TOST d_labes 2020-12-05 16:19
- CI inclusion ≠ TOST ElMaestro 2020-12-05 16:49
- CI inclusion ≠ TOST d_labes 2020-12-07 11:39
- CI inclusion ≠ TOST Helmut 2020-12-06 22:09
- CI inclusion operationally identical to TOST d_labes 2020-12-07 11:11
- WHO lamenting about terminology? Helmut 2020-12-07 13:02
- WHO lamenting about terminology? ElMaestro 2020-12-07 14:54
- WHO lamenting about terminology? d_labes 2020-12-07 15:35
- WHO lamenting about terminology? Helmut 2020-12-07 13:02
- CI inclusion operationally identical to TOST d_labes 2020-12-07 11:11
- CI inclusion ≠ TOST ElMaestro 2020-12-05 16:49
- CI inclusion ≠ TOST d_labes 2020-12-05 16:19
- CI inclusion ≠ TOST Helmut 2020-12-04 20:30
- WHO frequent deficiencies in protocols and reports Helmut 2020-12-22 19:00
- "obtain balanced groups" vs randomisationElMaestro 2020-12-23 08:12
- WHO frequent deficiencies in protocols and reports ElMaestro 2020-12-04 14:10
Ing. Helmut Schütz