top 5 warning signs your clinical trial is off track
Post on 26-Jan-2015
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Mark Shapiro, MBA, RACDirector, Clinical Solutions
Clinipace, Inc.
www.clinipace.com© 2003-2009 Clinipace, Inc. All Rights Reserved.
About Clinipace
Sites
Project Management Data Management
Clinical OperationsDesign and Analysis
StudyManager Investigator
Biostats CRAs
TEMPOPLATFORM
Full-service digital clinical research organization (dCRO)Full-service digital clinical research organization (dCRO)
www.clinipace.com© 2003-2009 Clinipace, Inc. All Rights Reserved. www.clinipace.com© 2003-2009 Clinipace, Inc. All Rights Reserved.
We already know
Thomson CenterWatch 2003, 2005 survey of sites in U.S.
www.clinipace.com© 2003-2009 Clinipace, Inc. All Rights Reserved.
Risk Management: A Four-Step ProcessRisk Management: A Four-Step Process
1. Risk Assessment and Analysis: Work with the Sponsor to agree on potential risks to the study across all study phases and then prioritize them in terms of importance
2. Risk Mitigation: Put in place processes or systems to proactively reduce the likelihood that identified risks become issues
3. Risk Measurement: Work with the Sponsor to agree on and implement measures necessary to assess risks and determine whether they have become issues
4. Risk Management: Define actions to be taken in response to those risks that become issues during the course of the study.
We define risks as potential events with a non-zero likelihood that could impact the timelines, cost, or quality of the study.
Recognizing warning signs that a trial is off track falls into the category of Risk Measurement
Risk Management Framework
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Warning Signs to Look for…Warning Signs to Look for…
CRF, database, and planning activities are driven off of a synopsis or draft protocol
Protocol not approved in first cycle of IRB reviewPoor site compliance with regulatory document
submissionsPoor Investigators’ Meeting attendance
CRF, database, and planning activities are driven off of a synopsis or draft protocol
Protocol not approved in first cycle of IRB reviewPoor site compliance with regulatory document
submissionsPoor Investigators’ Meeting attendance
How to measure…How to measure…
Close contact with central IRB% of PI’s that attend the IMClose contact with central IRB% of PI’s that attend the IM
How to fix…How to fix…
Gather site feedback on the draft protocol
Target key central IRB sites during start-up
Gather site feedback on the draft protocol
Target key central IRB sites during start-up
Related ChallengesRelated Challenges
Slower than expected enrollment
Slower than expected enrollment
Study Start-Up
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Warning Signs to Look for…Warning Signs to Look for… Target enrollment rate does not match historic rates Fewer sites than expected show interest in participating in
the study Study coordinators raise questions or concerns about the
inclusion/exclusion criteria or schedule of assessments High screen-failure rate observed Poor awareness of the treatment standard-of-care and /or
competitive landscape (global and local)
Target enrollment rate does not match historic rates Fewer sites than expected show interest in participating in
the study Study coordinators raise questions or concerns about the
inclusion/exclusion criteria or schedule of assessments High screen-failure rate observed Poor awareness of the treatment standard-of-care and /or
competitive landscape (global and local)
How to measure…How to measure…
Use technology to measure and monitor screening, enrollment, and screen failure rates
Reassess enrollment expectations at the PSV and IM
Use technology to measure and monitor screening, enrollment, and screen failure rates
Reassess enrollment expectations at the PSV and IM
How to fix…How to fix… Build enthusiasm for the
scientific aims of the study Focus on high-performing
sites Facilitate learning and
information-sharing across sites
Identify and activate back-up sites early
Build enthusiasm for the scientific aims of the study
Focus on high-performing sites
Facilitate learning and information-sharing across sites
Identify and activate back-up sites early
Related ChallengesRelated Challenges
First subject, first visit is delayed
First subject, first visit is delayed
Study Start-Up
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Early Warning Signs to Look for…Early Warning Signs to Look for…
Breakdown of the Sponsor-CRO relationshipStudy monitoring is poorly aligned with site
enrollmentProtocol amendments requiredPass-through costs are greater than expectedEnrollment lags expectations
Breakdown of the Sponsor-CRO relationshipStudy monitoring is poorly aligned with site
enrollmentProtocol amendments requiredPass-through costs are greater than expectedEnrollment lags expectations
How to measure…How to measure…Availability of PM or other key team membersOn-line monitoring visit calendarAnalyze spending rates on invoices
Availability of PM or other key team membersOn-line monitoring visit calendarAnalyze spending rates on invoices
How to fix…How to fix… Start with a clear and
comprehensive Communication and Risk management plan
Use remote and just-in-time monitoring
Validate site cost expectations before setting trial budget
Start with a clear and comprehensive Communication and Risk management plan
Use remote and just-in-time monitoring
Validate site cost expectations before setting trial budget
Related Warning SignsRelated Warning SignsSlower than expected
enrollmentProject team turnover
Slower than expected enrollment
Project team turnover
Study Operations
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Early Warning Signs to Look for…Early Warning Signs to Look for…
Historic turnover rateHistorical delays or challenges with the programRising starsAttitude and enthusiasm of the project teamAvailability of project team members
Historic turnover rateHistorical delays or challenges with the programRising starsAttitude and enthusiasm of the project teamAvailability of project team members
How to measure…How to measure…
Ask about turnover rate and transition plansPay attention to attitude and availability
Ask about turnover rate and transition plansPay attention to attitude and availability
How to fix…How to fix…Start with a clearly
defined transition planFollow the
Communication and Issue Escalation Plan
Manage quality of life challenges
Start with a clearly defined transition plan
Follow the Communication and Issue Escalation Plan
Manage quality of life challenges
Related Warning SignsRelated Warning SignsData Quality
ChallengesTrial Cost Overruns
Data Quality Challenges
Trial Cost Overruns
Study Operations
www.clinipace.com© 2003-2009 Clinipace, Inc. All Rights Reserved.
Early Warning Signs to Look for…Early Warning Signs to Look for…
Sites express concerns or have many questions about the protocol or schedule of assessments
Poor alignment of monitoring visits with site enrollment Inexperienced sites or monitorsHigh subject drop-out rateLag time for data entry at sitesHigh query rate (in general or around specific CRF fields)
Sites express concerns or have many questions about the protocol or schedule of assessments
Poor alignment of monitoring visits with site enrollment Inexperienced sites or monitorsHigh subject drop-out rateLag time for data entry at sitesHigh query rate (in general or around specific CRF fields)
How to measure…How to measure…Use technology to track questionsUse technology to measure data collection and drop-out
ratesMonitor query trends
Use technology to track questionsUse technology to measure data collection and drop-out
ratesMonitor query trends
How to fix…How to fix…
Maintain and FAQ starting from the PSV and IM through the study
Use experienced sites and monitors
Validate the protocol with the CRO and sites
Maintain and FAQ starting from the PSV and IM through the study
Use experienced sites and monitors
Validate the protocol with the CRO and sites
Related Warning SignsRelated Warning Signs
Project team turnoverProject team turnover
Study Operations
www.clinipace.com© 2003-2009 Clinipace, Inc. All Rights Reserved.
Q&A
Mark Shapiro, MBA, RACmshapiro@clinipace.com
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