Cohorts Backfilling

English translation: adding, enrolling aditional people

GLOSSARY ENTRY (DERIVED FROM QUESTION BELOW)
English term or phrase:Cohorts Backfilling
Selected answer:adding, enrolling aditional people

08:31 Jul 13, 2020
    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.)


English language (monolingual) [PRO]
Medical - Medical: Pharmaceuticals / Clinical ttudy
English term or phrase: Cohorts Backfilling
Hello. I would like to the meaning of 'Backling' here.

'Cohorts backfilling can be opened when a cohort has been completed …’
Mami Yamaguchi
Japan
Local time: 23:58
adding, enrolling aditional people
Explanation:
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.
Selected response from:

Nadyiia Derkach
Ukraine
Local time: 16:58
Grading comment
Thank you! I needed to get a detailed explanation.
4 KudoZ points were awarded for this answer



SUMMARY OF ALL EXPLANATIONS PROVIDED
3 +3adding, enrolling aditional people
Nadyiia Derkach
4Completion/Execution
Christina Katranidou


Discussion entries: 2





  

Answers


33 mins   confidence: Answerer confidence 4/5Answerer confidence 4/5
Completion/Execution


Explanation:
An example:"Subjects enrolled to backfill cohorts may be enrolled simultaneously......

Christina Katranidou
Greece
Local time: 16:58
Specializes in field
Native speaker of: Native in GreekGreek
Notes to answerer
Asker: Dear Christina , Thank you for your answer. It was very helpful!

Login to enter a peer comment (or grade)

34 mins   confidence: Answerer confidence 3/5Answerer confidence 3/5 peer agreement (net): +3
cohorts backfilling
adding, enrolling aditional people


Explanation:
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.

Nadyiia Derkach
Ukraine
Local time: 16:58
Native speaker of: Native in RussianRussian, Native in UkrainianUkrainian
PRO pts in category: 4
Grading comment
Thank you! I needed to get a detailed explanation.

Peer comments on this answer (and responses from the answerer)
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
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