Just in-time-clinical-trial-monitoring

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Carla Radke, BS, RN, CCRP

Laurin Mancour, CCRA, CCRP, RAC Mark Shapiro, MA, MBA, CCRA, RAC

5 KEY REASONS TO MAKE THE MOVE TO JUST-IN-TIME MONITORING

February 24, 2010



www.clinipace.comRIGHT-SIZEDTM CLINICAL RESEARCH SERVICES

Today’s webcast will cover

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•Detect and address problems early

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•Strengthen relationships with trial sites

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•Improve focus on Ethics and Regulatory Compliance

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•Mitigate CRA stress and burnout

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•Reduce the costs of conducting trials

Our goal today is to discuss what Just-in-time Monitoring is and how it can help:




Study Planning

Study Start-up Study Execution

Study Analysis

Study Reporting

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Clinical trials are complex [and expensive], and good monitoring can positively impact on site performance, timeline, and budget.

Moving to Just-in-Time Monitoring can make a significant impact on study execution

KeyMilestone

IND Acceptance

First Subject, First Visit Database Lock Statistical

ReportFinal Clinical Study

Report

Why are we here?




What is Just-in-Time Monitoring?

Just-in-Time monitoring is changing the paradigm for monitoring visit frequency from an elapsed duration (monitor the site every eight weeks) to an event-driven paradigm (monitor the site after the first and every third subject is enrolled or in the event of a protocol deviation). Just-in-Time monitoring is only possible with the use of EDC and the corresponding ability of CRAs to monitor the sites remotely (review enrollment, subject data, and queries) on a regular basis.




Detecting and addressing problems early

Just-in-Time monitoring helps to keep trials on track and reduce or mitigate certain trial risks. It can impact many trial metrics.

Site Activation• Cycle time to site qualification• Cycle time to first site activated• Cycle time to site activated • Regulatory pack approval rate• Percent planned sites activated

Site Performance• Cycle time from activation to FPFV• Site productivity (% meeting goals)• Screen failure rate• Patient accrual• Patient drop out rate

Data Quality• Cycle time to CRF data entry• Data discrepancies• Query response time• Source data verification

Close Out• Cycle time for query resolution• Cycle time from LPLV to data lock• Cycle time to site close out• Issue identification & resolution




Strengthening relationships with trial sites

First, focus on well-performing sitesThey will get you your patients and they will appreciate your support

Just-in-Time Monitoring isLess disruptive to site’s clinical activities and obligationsProactively identify issues and change behaviors, prior to the visitConsistent communication with sites and greater support

More and more monitoring activities can be done remotely and be less disruptive to the site

Just-in-Time monitoring is a vehicle to change the nature of the monitor-site relationship




Focusing on Ethics and Regulatory Compliance

Transparent access to study data enables monitors to identify issues, prior to study visitsFocus on more complex protocol-related issues and deviationsIncreased time available for ethical and regulatory compliance reviewsIncreased time available for site training and re-trainingTools and technology promote compliance by design

Edit checks promote protocol adherenceReports allow you to identify deviations and ensure proper AE reporting

With Just-in-Time Monitoring, more site time can be spent ensuring the trial is ethically executed and appropriately-documented.




Avoiding CRA stress and burnout

#1 Reason CRA’s say they quit their job? TOO MUCH TRAVELMore site transparency = less travel = happier monitorsHappier monitors = less employee turnover

Remote data monitoring permits less rushing, on-siteFaster source document verification when on-siteReduces the number of queries and protocol deviations

Learning curve for each new protocolSupported by a database that accounts for subject selection criteria that anticipates outliers as potential deviations




Let’s run the numbers, reducing trial costs

Consider the following hypothetical Phase II study scenario:

• 20 Sites• 138 Subjects• Active enrollment period of 8 months with 1 month of treatment/follow-up

Study Overview

• Site Activation is binomially distributed• Subject enrollment is Pareto distributed

Enrollment Parameters

• Interim site monitoring can be every four weeks, every six weeks, or Just-in-time during active enrollment.

• Monitoring visits require 12 hours of preparation, travel, and follow-up.• Each subject requires an average of 210 minutes to monitor• Each visit on site is rounded up to the nearest half-day• JIT monitoring is triggered by enrollment of the first and every third subject thereafter at each site

Monitoring Parameters




Initiate early to enroll more

As would be expected in a competitive enrollment study, sites that were initiated early enrolled more subjects.

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This graph shows the total number of hours required to monitor all subjects at each site under the three monitoring paradigms.

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Capacity more closely aligned to enrollment




Stop over monitoringpoorly enrolling sites

Scheduling monitoring based on elapsed time (q4 or q6 weeks) leads to less efficient deployment of resources than JIT monitoring at lower enrolling sites.

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• is the use of logical triggers based on enrollment, queries, or protocol deviations to allocate monitoring visits rather than conventional use of duration

• leads to more efficient use of monitoring resources as compared to conventional monitoring

• is particularly suited to studies with competitive enrollment

JIT Monitoring….

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Efficiency creates capacity




Q&A

CLINIPACE.COMCarla S. Radke {[email protected]}Laurin Mancour {[email protected]}Mark Shapiro {[email protected]}

Documents

Just in-time-clinical-trial-monitoring