Glossary entry (derived from question below)
Jun 17, 2010 07:05
13 yrs ago
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English term
Germany
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Works in: English to Russian, Russian to English
adjudicated
English
Medical
Medical (general)
What is the meaning of *adjudicated* in this context:
Should three blinded adjudicated clinical events of any one of the four events listed above occur in any individual study, an urgent ad hoc assessment by the DSMB will be conducted. In the event the adjudicated clinically significant adverse event is observed in 3 more patients in any individual XXX treatment group than for placebo-treated patients, the protocol-based rule for dosing suspension will be triggered
Should three blinded adjudicated clinical events of any one of the four events listed above occur in any individual study, an urgent ad hoc assessment by the DSMB will be conducted. In the event the adjudicated clinically significant adverse event is observed in 3 more patients in any individual XXX treatment group than for placebo-treated patients, the protocol-based rule for dosing suspension will be triggered
Responses
| 4 +1 | determined |
Ildiko Santana
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| 4 +1 | Judged/decided |
Anita du Plessis
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Change log
Nov 8, 2010 05:26: Ildiko Santana Created KOG entry
Responses
+1
7 hrs
Ildiko Santana
United States
United States
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United States
Accurate / Fast / Cheap -- Pick Two
Native in: Hungarian , English
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Related KudoZ points
:
4
Selected
determined
I don't think the verb "adjudicate" here is used in its (most common) legal sense but simply means that the DSMB has determined such event to be clinically significant. In layman terms we could replace the word "adjudicated" with "determined" and still arrive at the same meaning. For instance, in sports adjudication can be the process by which a winner is found, in health care it can refer to the process by which it is determined whether a claim is valid or not. In a legal process it is, in fact, a judgment or decision; here it carries somewhat less "weight," in my opinion, hence I would use "determined" as an alternative.
4 KudoZ points awarded for this answer.
+1
2 hrs
Anita du Plessis
South Africa
South Africa
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Related KudoZ points
:
12
Judged/decided
If the DSMB (Data Safety Monitoring Board) decided or judged the dosage caused an adverse condition (reaction) in patients (three or more) they will use their influence to suspend the trial.
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Note added at 3 hrs (2010-06-17 10:06:10 GMT)
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The DSMB is the watch dog over a clinical trial. A DSMB may recommend that a trial be stopped if there are safety concerns. It consists of an independant committee, composed of community representatives and clinical research experts. They review all data while a trial is in progress and ensure that participants are not exposed to undue risks.
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Note added at 3 hrs (2010-06-17 10:06:10 GMT)
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The DSMB is the watch dog over a clinical trial. A DSMB may recommend that a trial be stopped if there are safety concerns. It consists of an independant committee, composed of community representatives and clinical research experts. They review all data while a trial is in progress and ensure that participants are not exposed to undue risks.
Reference comments
3 hrs
Reference:
http://www.ijoonline.com/article.asp?issn=0019-5413;year=200...
Adjudication committee
This committee is designated to review important study end-points reported by the trial investigators. This is to determine whether they meet protocol-specified criteria.[1] To prevent bias, the adjudication committee is blinded to treatment allocation wherever possible.[15] If blinding is not feasible bias is prevented due to the independent nature of the adjudication committee. Especially for subjective outcome measures such as fracture healing, bias lures, therefore an adjudication committee can ensure the highest scientific quality of a trial.
Adjudication committee
This committee is designated to review important study end-points reported by the trial investigators. This is to determine whether they meet protocol-specified criteria.[1] To prevent bias, the adjudication committee is blinded to treatment allocation wherever possible.[15] If blinding is not feasible bias is prevented due to the independent nature of the adjudication committee. Especially for subjective outcome measures such as fracture healing, bias lures, therefore an adjudication committee can ensure the highest scientific quality of a trial.
Peer comments on this reference comment:
| agree |
Tina Vonhof (X)
: It is not the DSMB that does the adjudicating but a separate committee of experts. See also: http://www.proz.com/kudoz/english_to_german/medical_general/... adjudicated_event.html // It was meant as an agreement.
4 hrs
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Yes, I had worked that out:) Thank you!/Sure thing...I was just making a comment:)
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| agree |
Ildiko Santana
: Yes, as you quote above, "this is to determine." Not sure if Tina's comment is applicable in this context, as the source clearly names the DSMB in this particular case, see: "...assessment by the DSMB will be conducted."
6 hrs
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