Glossary entry

English term or phrase:

Cohorts Backfilling

English answer:

adding, enrolling aditional people

    The asker opted for community grading. The question was closed on 2020-07-17 01:58:52 based on peer agreement (or, if there were too few peer comments, asker preference.)
Jul 13, 2020 08:31
3 yrs ago
125 viewers *
English term

Cohorts Backfilling

English Medical Medical: Pharmaceuticals Clinical ttudy
Hello. I would like to the meaning of 'Backling' here.

'Cohorts backfilling can be opened when a cohort has been completed …’

Discussion

Christina Katranidou Jul 13, 2020:
First of all the term as written is giving us little details and most importantly I can't believe that someone with no relevant background is given the task of translating such terminology.
I am writing these as an experienced professional in the field.
Yvonne Gallagher Jul 13, 2020:
@ Asker could you give more context? This can mean different things. You haven't even given a complete sentence here.

Responses

+3
34 mins
Selected

adding, enrolling aditional people

https://www.centerwatch.com/clinical-trials/listings/115900/...
Looks like this is adding more subjects to completed groups.
Quote:
For cohorts in dose escalation, concurrent with the 3+3 dose escalation schema, additional subjects will be backfilled to lower dose levels to ensure that each cohort enrolls a total of 10 subjects. Subjects enrolled to backfill cohorts may be enrolled simultaneously, without sequential dosing (i.e., not required to wait 48 hours between 2 subjects). These additional subjects at each dose level will have the purpose of generating additional safety, PK, and receptor occupancy data, and will not undergo formal DLT observation.
Peer comment(s):

agree philgoddard
3 hrs
Thank you :)
agree Tina Vonhof (X)
5 hrs
Thank you :)
agree P Waters
5 hrs
Thank you :)
neutral Yvonne Gallagher : asker can't be bothered to give context. It might mean this but could mean 2 other things as well
1 day 30 mins
Something went wrong...
4 KudoZ points awarded for this answer. Comment: "Thank you! I needed to get a detailed explanation."
33 mins

Completion/Execution

An example:"Subjects enrolled to backfill cohorts may be enrolled simultaneously......
Note from asker:
Dear Christina , Thank you for your answer. It was very helpful!
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