BioClinica Imaging Metrics Case Study

BioClinica Case Study:Using Imaging Performance Metrics toImprove Sponsor, Site, and Core Lab ClinicalTrial OperationsDawn Flitcraft, VP Client ServicesJennifer Schick, Project Director OncologyDana Curcio, Project Director RA/Inflamm18 January 2012

Background on BioClinica’s Involvement with the MCCBioClinica is a founding Imaging Core Lab member ofthe MCC. The involvement began in November 2007with BioClinica holding a position on the initial SteeringCommittee. During the initiation phase, WorkingGroups were established to drive a core set of metricsfor moving forward. BioClinica representation waspresent on all of these Working Groups includingOperational, Finance, and Clinical. BioClinica continuesto be a member of the Steering Committee andImaging Metrics and Implementation Working groupstoday.2

Why utilize MCC Imaging Performance Metrics?From the sponsor’s perspective:• Enhanced understanding of the services imaging core labs provide• Improved monitoring and evaluation of a core lab’s ability to meet critical timelines• Ability to pinpoint areas of interest & utilize both sponsor and core lab knowledge bases to improve processes for on-going processes• Enhanced partnership relationships through improved communication among all parties3

Why utilize MCC Imaging Performance Metrics?From the service provider’s perspective:• Identification of client’s business requirements• Enhanced understanding of client’s processes• Improved monitoring of client’s critical deliverables• Identification of key metrics that the client is focused on• Greater focus on achieving meaningful process improvement• Higher customer satisfaction4

Example 1: Site Start-UpMCC Metric Catalyst – Site Start Up:Percentage of Sites Qualified vs Actual

Using Metrics to Improve QualityExample 1: Site Start-UpMCC Metric Catalyst – Site Start Up: Percentage of Sites Qualified vs Actual ReportingDefinition Unit of Measure Target FrequencyThe average number of days from when a site survey issent to the site and when the site returns the Days Bi-Weekly 14 dayscompleted survey to BioClinica.Context:As part of the startup process for clinical studies, BioClinica collects important technicalinformation such as the name of imaging equipment manufacturer, model and software versionfor each participating site. BioClinica then provides each investigator with specific imageacquisition parameters. These surveys must be received and completed in order for sites toreceive their Imaging study kits, which are tailored to the sites requirements. The site cannotbegin imaging subjects until these kits have been received.For the global study profiled here, site surveys were targeted to be completed and returned toBioClinica within 14 business days. If completed surveys were not received within 7 days,BioClinica’s process included sending a second follow-up request.6

Using Metrics to Improve QualityExample 1: Site Start-UpMCC Metric Catalyst – Site Start Up: Percentage of Sites Qualified vs Actual ReportingDefinition Unit of Measure Target FrequencyThe average number of days from when a site survey issent to the site and when the site returns the Days Bi-Weekly 14 dayscompleted survey to BioClinica.Review Steps:• Analysis of “surveys completed” found that the average turnaround time for survey completion was consistently greater than the target of 14 business days and was on average greater than 35 days.• The BioClinica team suggested that improving accountability at the site level for survey completion as well as improving follow up communications would help to motivate better compliance.7

Using Metrics to Improve QualityExample 1: Site Start-UpMCC Metric Catalyst – Site Start Up: Percentage of Sites Qualified vs Actual ReportingDefinition Unit of Measure Target FrequencyThe average number of days from when a site survey issent to the site and when the site returns the Days Bi-Weekly 14 dayscompleted survey to BioClinica.Action Steps:• The BioClinica team recommended the implementation of bi-weekly regional CRA teleconferences to review site survey status in detail.• Equipped with the up-to-date facts, the CRAs followed up directly to encourage sites to send the missing information. The sponsor supported this recommendation.8

Using Metrics to Improve QualityExample 1: Site Start-UpMCC Metric Catalyst – Site Start Up: Percentage of Sites Qualified vs Actual Unit of ReportingDefinition Target Measure FrequencyThe average number of days from when a site survey is sentto the site and when the site returns the completed survey Days Bi-Weekly 14 daysto BioClinica. Results: Within two months this initiative demonstrated positive results, the survey completion rose to 95% (2.48 day turnaround) and 96% (3 day turnaround) respectively. Currently, sites are doing far better than the target of 14 days to complete surveys and are providing completed site surveys to BioClinica within an average of 3 business days after survey receipt.9

Using Metrics to Improve QualityExample 1: Site Start-UpMCC Metric Catalyst – Site Start Up: Percentage of Sites Qualified vs ActualLessons Learned• The importance of Site Survey completion should be emphasized at the Investigator Meeting, especially the CRA involvement.• Samples of the survey and live demonstrations aid in the learning process and should be available.• Simplification of the survey improved compliance of the site survey process.• Distribution of the site surveys was coordinated with the initiation visits.• When surveys were provided too early in the site approval process, they went unnoticed and delayed in overall response time. In some instances, they needed to be re-routed for completion.10

Example 2: Image ProcessingMCC Metric Used – Average number ofCalendar Days from Image Receipt toReady for Independent Review

Using Metrics to Improve QualityExample 2: Image ProcessingMCC Metric Used – Average number of Calendar Days from Image Receiptto Ready for Independent Review ReportingDefinition Unit of Measure Target FrequencyAverage number of calendar days from when the image Days Bi-weekly 4-6 daysis designated for review to completion of the reviewContext:BioClinica was contracted to perform an oncology study with a central radiological evaluation(read) of the CT images that required confirmation of progression by central readers, while bothCT and Nuclear Medicine modalities were required for submission. Specifically, the site wasrequired to notify BioClinica via a transmittal form of site-suspected progression on for each timepoint where progression existed, triggering initiation of a central read. A 4-6 business dayturnaround was required at BioClinica from receipt of this time point to completion of the centralread including notification of the read result to the site.12

Using Metrics to Improve QualityExample 2: Image ProcessingMCC Metric Used – Average number of Calendar Days from Image Receiptto Ready for Independent Review ReportingDefinition Unit of Measure Target FrequencyAverage number of calendar days from when the image Days Bi-weekly 4-6 daysis designated for review to completion of the reviewReview Steps:• An initial review of the metric indicated that the average Turn Around Time (TAT) was consistently greater than the target of 6 business days.• Further analysis determined that much of the delay was due to sites submitting incomplete imaging sets: Both CT and Nuclear Medicine modalities were required and quite often sites were submitting only one of the two required image sets.13

Using Metrics to Improve QualityExample 2: Image ProcessingMCC Metric Used – Average number of Calendar Days from Image Receiptto Ready for Independent Review ReportingDefinition Unit of Measure Target FrequencyAverage number of calendar days from when the image Days Bi-weekly 4-6 daysis designated for review to completion of the reviewAction Steps:BioClinica, in collaboration with the sponsor and CRO, made the decision to track an additionalpoint in the process (i.e., Day 1 of the central read process would be based on the date a completeimage set was received with no outstanding queries or the date that a site confirmed that noadditional image data was acquired or could be submitted).14

Using Metrics to Improve QualityExample 2: Image ProcessingMCC Metric Used – Average number of Calendar Days from Image Receiptto Ready for Independent Review Unit of ReportingDefinition Target Measure FrequencyAverage number of calendar days from when the image is Days Bi-weekly 4-6 daysdesignated for review to completion of the review Image Receipt to Readiness for Review Results: 14 Using the more redefined start date of 12 Day 1, the team tracked the TAT from 10 data ready for the read to site being 8 notified of the read result to track Days 6 adherence to target metrics. 4 TAT 2 Revised TAT 0 26-Aug 12-Sep 28-Sep 14-Oct15

Using Metrics to Improve QualityExample 2: Image ProcessingMCC Metric Used – Average number of Calendar Days from Image Receiptto Ready for Independent ReviewLessons Learned• The revised TAT definition allowed BioClinica to look at the time lapse between when the site notified BioClinica of suspected progression and Day 1.• BioClinica helped the sponsor to identify which sites should receive additional training to improve compliance and data quality.• In addition, BioClinica worked in partnership with the sponsor’s CRO to determine if missing scans were even acquired per the clinical database, allowing in some scenarios for the read to be conducted without waiting for site feedback.16

SummaryBioClinica utilized metrics that correspond to MCC imaging performancemetrics (v1.0) for Start Up and for Image Processing, on two global projectsof differing therapeutic areas. The utilization of such standardized metricsallowed monitoring of deliverables and provided the ability to pinpointareas that could be improved during the trial process. As indicated byresults from these two examples, application of such metrics resulted inreduction of specific task completion times. Decreases in these completiontimes drive greater patient recruitment efficiencies.BioClinica’s standard reports currently include seventeen different MCCImaging Performance metrics. In addition to the improvements as notedabove, using these metrics has also resulted in internal improvements inteam and employee performance. Due to the establishment andachievement of clearly defined goals and targets on a per project basis,BioClinica encourages the use of the MCC standardized metrics in all clinicaltrial projects.17

BioClinica Imaging Metrics Case Study

by BioClinica on Jan 19, 2012

Accessibility

Categories

Tags

Upload Details

Usage Rights

1 Embed 2

Statistics

BioClinica Imaging Metrics Case Study — Presentation Transcript