A risk-management approach for effective integration of biomarkers in clinical trials: perspectives of an NCI, NCRI, and EORTC working group.
Clinical cancer research today often includes testing the value of biomarkers to direct treatment and for drug development. However, the practical challenges of integration of molecular information into clinical trial protocols are increasingly appreciated. Inherent difficulties include evidence gap...
| Main Authors: | , , , , |
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| Format: | Journal article |
| Language: | English |
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Lancet
2014
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| _version_ | 1797051087885172736 |
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| author | Hall, J Salgado, R Lively, T Sweep, F Schuh, A |
| author_facet | Hall, J Salgado, R Lively, T Sweep, F Schuh, A |
| author_sort | Hall, J |
| collection | OXFORD |
| description | Clinical cancer research today often includes testing the value of biomarkers to direct treatment and for drug development. However, the practical challenges of integration of molecular information into clinical trial protocols are increasingly appreciated. Inherent difficulties include evidence gaps in available biomarker data, a paucity of robust assay methods, and the design of appropriate studies within the constraints of feasible trial operations, and finite resources. Scalable and proportionate approaches are needed to systematically cope with these challenges. Therefore, we assembled international experts from three clinical trials organisations to identify the common challenges and common solutions. We present a practical risk-assessment framework allowing targeting of scarce resources to crucial issues coupled with a library of useful resources and a simple actionable checklist of recommendations. We hope that these practical methods will be useful for running biomarker-driven trials and ultimately help to develop biomarkers that are ready for integration in routine practice. |
| first_indexed | 2024-03-06T18:14:52Z |
| format | Journal article |
| id | oxford-uuid:044691d4-e4aa-4886-b17a-b1da38398c5f |
| institution | University of Oxford |
| language | English |
| last_indexed | 2024-03-06T18:14:52Z |
| publishDate | 2014 |
| publisher | Lancet |
| record_format | dspace |
| spelling | oxford-uuid:044691d4-e4aa-4886-b17a-b1da38398c5f2022-03-26T08:50:52ZA risk-management approach for effective integration of biomarkers in clinical trials: perspectives of an NCI, NCRI, and EORTC working group.Journal articlehttp://purl.org/coar/resource_type/c_dcae04bcuuid:044691d4-e4aa-4886-b17a-b1da38398c5fEnglishSymplectic Elements at OxfordLancet2014Hall, JSalgado, RLively, TSweep, FSchuh, AClinical cancer research today often includes testing the value of biomarkers to direct treatment and for drug development. However, the practical challenges of integration of molecular information into clinical trial protocols are increasingly appreciated. Inherent difficulties include evidence gaps in available biomarker data, a paucity of robust assay methods, and the design of appropriate studies within the constraints of feasible trial operations, and finite resources. Scalable and proportionate approaches are needed to systematically cope with these challenges. Therefore, we assembled international experts from three clinical trials organisations to identify the common challenges and common solutions. We present a practical risk-assessment framework allowing targeting of scarce resources to crucial issues coupled with a library of useful resources and a simple actionable checklist of recommendations. We hope that these practical methods will be useful for running biomarker-driven trials and ultimately help to develop biomarkers that are ready for integration in routine practice. |
| spellingShingle | Hall, J Salgado, R Lively, T Sweep, F Schuh, A A risk-management approach for effective integration of biomarkers in clinical trials: perspectives of an NCI, NCRI, and EORTC working group. |
| title | A risk-management approach for effective integration of biomarkers in clinical trials: perspectives of an NCI, NCRI, and EORTC working group. |
| title_full | A risk-management approach for effective integration of biomarkers in clinical trials: perspectives of an NCI, NCRI, and EORTC working group. |
| title_fullStr | A risk-management approach for effective integration of biomarkers in clinical trials: perspectives of an NCI, NCRI, and EORTC working group. |
| title_full_unstemmed | A risk-management approach for effective integration of biomarkers in clinical trials: perspectives of an NCI, NCRI, and EORTC working group. |
| title_short | A risk-management approach for effective integration of biomarkers in clinical trials: perspectives of an NCI, NCRI, and EORTC working group. |
| title_sort | risk management approach for effective integration of biomarkers in clinical trials perspectives of an nci ncri and eortc working group |
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