Glossary entry (derived from question below)
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 …’
'Cohorts backfilling can be opened when a cohort has been completed …’
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.
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 :)
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agree |
Tina Vonhof (X)
5 hrs
|
Thank you :)
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agree |
P Waters
5 hrs
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Thank you :)
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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
|
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! |
Discussion
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