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The clinical trial assessment of infrastructure matrix tool (CT AIM) to improve the quality of research conduct in the community.
Abstracts that were granted an exception in accordance with ASCO's Conflict of Interest Policy are designated with a caret symbol (^).
Background: ASCO described minimum standards and exemplary attributes for CT sites to improve research quality (Zon et al JCO 2008, JOP 2011; Baer et al JOP 2010). Based on these attributes, the NCI Community Cancer Centers Program (NCCCP) developed and piloted the CT AIM Tool to facilitate research program improvements through self-assessment and benchmarking. The tool identified 9 attributes (see Table) each with 3 progressive levels for research sites to “score” their program from less (Level 1) to more (Level 3) exemplary CT infrastructure (e.g. Level 1- only phase 3 treatment trials open vs. Level 3 – Phase 1/2/3, cancer control and prevention trials open). Methods: From 2011-13, 21 NCCCP sites self assessed their CT programs annually using the tool. Results: See Table. Conclusions: Statistically significant increases (p < 0.0001) occurred in Level 3 (more exemplary) infrastructure ratings from 2011 to 2013 across all 9 attribute categories assessed at the 21 sites. Statistically significant gains were seen in two attributes: CT Portfolio – increases in site early phase and cancer control trial implementation; CT Communication /Awareness - shifts observed from institutionally focused CT education to broader community outreach/engagement. The tool showed utility across the sites for promoting quality improvement, benchmarking research performance, progress reporting and providing metrics for communicating infrastructure needs. Use in research beyond oncology and outside the community setting is plausible. NCI Contract HHSN261200800001E.
|Attribute and year||Level (1-3) and No. of sites (n=21)|
|CT communication/awareness* p 0.0281|
|Participation in CT process|
|Physician CT engagement|
|CT portfolio * p 0.0228|
|Community outreach/underserved accrual|
|Level 3 scores for ALL attribute categories from 2011 to 2013* p < 0.0001|
* Significant p value for change over time.
Abstracts by Eileen P. Dimond:
Meeting: 2014 ASCO Quality Care Symposium
| Abstract No: 230
Category: Science of Quality - Quality Improvement
Early-phase (EP) clinical trials (CTs) in the community: Results from the National Cancer Institute (NCI) Community Cancer Centers Program (NCCCP) Early-Phase Working Group (EPWG) Baseline Assessment Study (BAS).Meeting: 2012 ASCO Annual Meeting | Abstract No: e16561
Presentations by Eileen P. Dimond:
The clinical trial assessment of infrastructure matrix tool (CT AIM) to improve the quality of research conduct in the community.Meeting: 2014 ASCO Annual Meeting Abstract No: 6512Session: Optimizing Access to Clinical Trials in Community Practice (Clinical Science Symposium)