Subjective endpoints in clinical trials: the case for blinded independent central review
Richard Walovitch,1 Bin Yao,2 Patrick Chokron,1 Helen Le,1 Glenn Bubley3 1WorldCare Clinical, LLC, Boston, MA, USA; 2Amgen, Inc, Thousand Oaks, CA, USA; 3Director of Genitourinary Medical Oncology, Beth Israel Deaconess Medical Center, Boston, MA, USA Abstract: Primary efficacy and safety endpoints...
| Main Authors: | , , , , |
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| Format: | Article |
| Language: | English |
| Published: |
Dove Medical Press
2013-09-01
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| Series: | Open Access Journal of Clinical Trials |
| Online Access: | http://www.dovepress.com/subjective-endpoints-in-clinical-trials-the-case-for-blinded-independe-a14484 |
| _version_ | 1818114649176932352 |
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| author | Walovitch R Yao B Chokron P Le H Bubley G |
| author_facet | Walovitch R Yao B Chokron P Le H Bubley G |
| author_sort | Walovitch R |
| collection | DOAJ |
| description | Richard Walovitch,1 Bin Yao,2 Patrick Chokron,1 Helen Le,1 Glenn Bubley3 1WorldCare Clinical, LLC, Boston, MA, USA; 2Amgen, Inc, Thousand Oaks, CA, USA; 3Director of Genitourinary Medical Oncology, Beth Israel Deaconess Medical Center, Boston, MA, USA Abstract: Primary efficacy and safety endpoints in clinical trials are often subjective assessments made by site personnel. For international confirmatory trials conducted over broad geographic regions and different clinical practice settings, variability in these subjective assessments can be substantial. Centralized endpoint assessment committees (EACs) offer a mechanism through which to reduce assessment bias and potentially increase assessment precision and accuracy, particularly in open-label trials. An overview of regulatory agencies' rationales for an EAC is reviewed. In addition, the two main types of EACs, the blinded independent central review, and the consensus panel are compared. Selection of endpoints for EAC evaluation and design of EAC process to maximize EAC value proposition are also discussed. Keywords: endpoint assessment committee, FDA, central review, BICR, adjudication, consensus panel |
| first_indexed | 2024-12-11T03:54:05Z |
| format | Article |
| id | doaj.art-0ac5cf7967fa4570931be83ec0f2c937 |
| institution | Directory Open Access Journal |
| issn | 1179-1519 |
| language | English |
| last_indexed | 2024-12-11T03:54:05Z |
| publishDate | 2013-09-01 |
| publisher | Dove Medical Press |
| record_format | Article |
| series | Open Access Journal of Clinical Trials |
| spelling | doaj.art-0ac5cf7967fa4570931be83ec0f2c9372022-12-22T01:21:50ZengDove Medical PressOpen Access Journal of Clinical Trials1179-15192013-09-012013default111117Subjective endpoints in clinical trials: the case for blinded independent central reviewWalovitch RYao BChokron PLe HBubley GRichard Walovitch,1 Bin Yao,2 Patrick Chokron,1 Helen Le,1 Glenn Bubley3 1WorldCare Clinical, LLC, Boston, MA, USA; 2Amgen, Inc, Thousand Oaks, CA, USA; 3Director of Genitourinary Medical Oncology, Beth Israel Deaconess Medical Center, Boston, MA, USA Abstract: Primary efficacy and safety endpoints in clinical trials are often subjective assessments made by site personnel. For international confirmatory trials conducted over broad geographic regions and different clinical practice settings, variability in these subjective assessments can be substantial. Centralized endpoint assessment committees (EACs) offer a mechanism through which to reduce assessment bias and potentially increase assessment precision and accuracy, particularly in open-label trials. An overview of regulatory agencies' rationales for an EAC is reviewed. In addition, the two main types of EACs, the blinded independent central review, and the consensus panel are compared. Selection of endpoints for EAC evaluation and design of EAC process to maximize EAC value proposition are also discussed. Keywords: endpoint assessment committee, FDA, central review, BICR, adjudication, consensus panelhttp://www.dovepress.com/subjective-endpoints-in-clinical-trials-the-case-for-blinded-independe-a14484 |
| spellingShingle | Walovitch R Yao B Chokron P Le H Bubley G Subjective endpoints in clinical trials: the case for blinded independent central review Open Access Journal of Clinical Trials |
| title | Subjective endpoints in clinical trials: the case for blinded independent central review |
| title_full | Subjective endpoints in clinical trials: the case for blinded independent central review |
| title_fullStr | Subjective endpoints in clinical trials: the case for blinded independent central review |
| title_full_unstemmed | Subjective endpoints in clinical trials: the case for blinded independent central review |
| title_short | Subjective endpoints in clinical trials: the case for blinded independent central review |
| title_sort | subjective endpoints in clinical trials the case for blinded independent central review |
| url | http://www.dovepress.com/subjective-endpoints-in-clinical-trials-the-case-for-blinded-independe-a14484 |
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