What is this thing called?
June 10, 2011 10:43 PM Subscribe
A multicenter drug study takes CT scans of all subjects at various points. These scans are all sent to a central committee for evaluation. What is this committee called? My Google-Fu is failing me, and I don't get any convincing hits for "Central CT Scan Evaluation Committee" etc. etc.
Generically it could have a number of different names: Review Committee, Examining Committee, Oversight Committee, Evaluating Committee, Audit Committee, Assessment Committee, Advisory Committee. It depends on the nature of their role. Are they providing independent verification, or analyzing known conclusions, or supervising/guiding the research, or... ?
posted by amyms at 12:58 AM on June 11, 2011
posted by amyms at 12:58 AM on June 11, 2011
Just thought of another possibility: Accountability Committee
posted by amyms at 1:03 AM on June 11, 2011
posted by amyms at 1:03 AM on June 11, 2011
Clinical Case Review?
posted by vitabellosi at 2:21 AM on June 11, 2011
posted by vitabellosi at 2:21 AM on June 11, 2011
An Institutional Review Board is required for medical studies. I supect that this is what you have in mind.
posted by yclipse at 5:31 AM on June 11, 2011
posted by yclipse at 5:31 AM on June 11, 2011
Clinical Coordinating Center? Also seconding Institutional Review Board and Data Safety Monitoring Board.
posted by genehack at 5:46 AM on June 11, 2011
posted by genehack at 5:46 AM on June 11, 2011
IANAD, but I work on the periphery of this process. The specifics could be different in this study, but you would need to know the purpose of the group reviewing the CT scans to be able to determine their "name".
It depends whether the purpose of the committee is to determine if a positive (or negative) outcome of the study goals has been reached for the patient concerned, or to review the scan for safety, etc.
The IRB (Institutional Review Board) (aka Ethics Committee in Europe) is mostly about overall study ethics, compliance and would include review of safety issues that arise during the study. But they don't necessarily get passed all the data. Especially if there's a safety issue that is missed because it's buried in the data (e.g.. slowly rising lab values for a given patient that would be bad in the long term, etc.)
Sometimes you need a Data Safety Monitoring Board to periodically check if there are any *missed* safety issues. If discovered, these would go up to the IRB and out to all the investigators, etc. DSMBs are sometimes called "Drug Safety Committees", "Study Safety Committees", "External Safety Review Board", and other various names.
(Sometimes there are two such groups: "Safety Review Board", and "External Safety Review Board". The latter are more important when the study is in patients who might be expected to die or have a bad outcome regardless of the study - the study may be looking at painkillers in cancer, etc. which may not cause the bad outcome, but which might work quite well as painkillers, but someone has to vet the painkillers as not causing or hastening bad things.)
Sometimes you need an Adjudication process to review lab results / ct scans, etc. to determine if the patient has "gotten better" due to the study treatment, or "gotten worse" to the extent of requiring to drop out of the study and do something else. I put these terms in quotes, because these don't necessarily mean "healed" or "not healed". An adjudication process might require two of a pool of three or more specialists to review the CT scan, and if they agree, then that's the result. If they disagree, a third specialist or some escalation process kicks in.
posted by blue_wardrobe at 11:40 AM on June 11, 2011 [1 favorite]
It depends whether the purpose of the committee is to determine if a positive (or negative) outcome of the study goals has been reached for the patient concerned, or to review the scan for safety, etc.
The IRB (Institutional Review Board) (aka Ethics Committee in Europe) is mostly about overall study ethics, compliance and would include review of safety issues that arise during the study. But they don't necessarily get passed all the data. Especially if there's a safety issue that is missed because it's buried in the data (e.g.. slowly rising lab values for a given patient that would be bad in the long term, etc.)
Sometimes you need a Data Safety Monitoring Board to periodically check if there are any *missed* safety issues. If discovered, these would go up to the IRB and out to all the investigators, etc. DSMBs are sometimes called "Drug Safety Committees", "Study Safety Committees", "External Safety Review Board", and other various names.
(Sometimes there are two such groups: "Safety Review Board", and "External Safety Review Board". The latter are more important when the study is in patients who might be expected to die or have a bad outcome regardless of the study - the study may be looking at painkillers in cancer, etc. which may not cause the bad outcome, but which might work quite well as painkillers, but someone has to vet the painkillers as not causing or hastening bad things.)
Sometimes you need an Adjudication process to review lab results / ct scans, etc. to determine if the patient has "gotten better" due to the study treatment, or "gotten worse" to the extent of requiring to drop out of the study and do something else. I put these terms in quotes, because these don't necessarily mean "healed" or "not healed". An adjudication process might require two of a pool of three or more specialists to review the CT scan, and if they agree, then that's the result. If they disagree, a third specialist or some escalation process kicks in.
posted by blue_wardrobe at 11:40 AM on June 11, 2011 [1 favorite]
Response by poster: Thanks everybody for the feedback. I'll pick something appropriate, but it's good to know there isn't a set phrase I'm missing.
posted by zachawry at 3:30 AM on June 14, 2011
posted by zachawry at 3:30 AM on June 14, 2011
This thread is closed to new comments.
posted by drpynchon at 10:54 PM on June 10, 2011