DDTBMQ000011: advance tumor volume change as measured by CT as a pharmacodynamic biomarker for new oncologic drug clinical trial therapy of solid tumors to stage 2 of FDA biomarker qualification
Ended Cooperative Agreement Awarded Last action
- Award ID
- U01FD007470
- Recipient
-
CCS Associates, Inc. UEI VCNRS52G5PG7
- Awarding agency
-
FDA Office of Acquisition and Grant Services
Food and Drug Administration, Department of Health and Human Services
- Obligated
- $745,842
Award facts
- Assistance listing
- 93.103 Food and Drug Administration Research
- Completion date
- Originally
- Funding
-
- $497,228.00 Federal
- $248,614.00 Non-federal
- Funding agency
- Center for Drug Evaluation and Research Food and Drug Administration, Department of Health and Human Services
- Place of performance
- San Jose, CA 95131, USA
Award details come from USAspending.gov.
Description
- Abstract
- The overall objective of this project is to advance the biomarker qualification application DDTBMQ000011 from the current stage 1 to stage 2 of the FDA biomarker qualification process. The scope of this project is based on recommendations from the FDA BQP review team that were communicated in the determination letter for accepting the legacy biomarker qualification proposal into the 507 process, on additional advice received from the subsequent debriefing meeting, and on FDA guidance documents. A FDA BQP-suggested study will be conducted to assess agreement between the qiba profile's CT volumetry biomarker definition of change (ctvol) and the recist system using the categories of responsive, stable, or progressive disease. Disagreements between the two approaches will be further broken down as: (i) substantive disagreement, where the disagreement between recist and CT volumetry cannot be attributable to improved sensitivity with CT volumetry and (II) disagreement potentially due to improved sensitivity with CT volumetry. Factors predictive of disagreement will be identified. The null hypothesis is that the proportion of lesions with substantive disagreement is >15%; the alternative hypothesis is that the proportion of lesions with substantive disagreement is
Transactions
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| Amendment | $0 | $0 | |
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| Amendment | $248,614 | $0 | |
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| Amendment | -$248,614 | $0 | |
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| Amendment | $248,614 | $0 | |
| Original award | $248,614 | $248,614 |
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Quick answers
Who received award U01FD007470?
U01FD007470 was awarded to CCS Associates, Inc. by FDA Office of Acquisition and Grant Services (Food and Drug Administration) on September 1, 2021.
How much is award U01FD007470 worth?
$745,842 has been obligated on U01FD007470: $497,228 in federal funding and $248,614 in non-federal funding.
Which agency awarded U01FD007470?
FDA Office of Acquisition and Grant Services (Food and Drug Administration) awarded U01FD007470, with funding from Center for Drug Evaluation and Research (Food and Drug Administration).
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