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Leverage Your EDC Solution to Mitigate Risk in Clinical Research

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www.datatrak.com
www.datatrak.com

Every clinical trial is built upon a study protocol - the cornerstone of any trial. A well-defined and written study protocol provides the blueprint for the study, defining its purpose and goals. Studies have become more complex, creating more complicated study design, which can lead to making adherence more challenging for the study team and participants. The potential risk that some aspect of the study could be done incorrectly or not comply is inherent in all studies, but particularly present in complex research. In order to help mitigate risk, advances in technology and the tools available today provide ways for us to mitigate some of the risk introduced in our clinical trials. While the study protocol is a cornerstone for the clinical trial, electronic data capture (EDC) applications have evolved in the broadest sense into technology solutions that provide us with a variety of tools to help mitigate risk.

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LeveragingYour EDC Application to Mitigate Risk in ClinicalTrials March 25, 2015
Confidential – Your Speaker ► Bill Gluck, Ph.D. • Dr. Gluck has over 30 years of expertise in clinical research, with experience in sponsors, CROs, and with DATATRAK in a variety of roles. Dr. Gluck is also the Program Director for the Clinical Trials Research and Medical Product Safety/Pharmacoviligance programs at DurhamTechnical Community College. Dr. Gluck earned his Bachelor of Science Degree at the University of Scranton and Master and Ph.D. degrees from North Dakota State University. 2
Confidential – Our DiscussionTopics • Definition and Perception of ‘Risk’ • Risk-Based Quality Management • How Can We Mitigate Our Risk Profile – Approaches to Reducing Risk – Review, Report, Communicate – Leveraging Technological Tools • Summary
Confidential – Every Clinical Trial Has Inherent Risk and Every Risk Has aTolerance Limit 4
Confidential – Risk 5 Risk is an uncertain event or condition that, if it occurs, has an effect on at least one objective.
Confidential – Mitigating Risk 6 Taking steps to reduce adverse effects.
Confidential – Tolerance 7 There is no way a sponsor can eliminate all risks of doing clinical trials so defining the amount and identifying the type of risk that a sponsor is willing to accept helps them evaluate where resources should allocated to minimize the most significant risks.
Confidential – Perception of Risk Role and Responsibilities – Sponsor – Investigator – IRB/Ethics Committee Member – Quality Representative – Regulator
Confidential – Risk-Based Quality Management • Start with Quality – End with Quality – A systematic process to identify, assess, control, communicate, and review risks associated with the trial throughout the life of the trial
Confidential – One Approach To Risk Mitigation Identify & Assess Control Review & Communicate 10
Confidential – Identify and Assess Risk • Privacy Protection of Study Participants • Patient/Subject Safety • Quality/Reliability of Study Data
Confidential – Controlling Risk • What decisions can be made to reduce and/or accept risk? • Where can we mitigate risk? • How can we accomplish this?
Confidential – Review and Communication • Document your process • Communicate the process • Review results • Incorporate new information • Update and revise your plan as needed
Confidential – Develop and Implement A Plan • Building on the answers – Develop a plan – Implement action for high risk – Understand there may be implications with low risk
Confidential –
Confidential – How Do We Do This? • Separate prioritization from risk mitigation • Address each stage of the trial • Stratify/Customize the plan
Confidential – Setting Boundaries – Early and Often • Trial Data • Monitor Protocol Compliance/Deviations • Establish Qualification Standards/Specifications • Define Metrics to Allow Oversight – Data Collection, Retrieval, and Reporting – RBM – Quality Measures
Confidential – A Sample Template Header Categories Risk Area/Category Potential Risk Assessed Risk Examples/List study specific issues Include in Monitoring Plan (Yes/No) ToleranceThreshold Mitigation Strategies/Tools to be Used 18
Confidential – Sample Template Header 19 Risk Assessment Worksheet Risk Area/Category Potential Risk Assessed Risk Examples (list study specific issues) Include in Monitoring Plan (Yes/No) Tolerance Threshhold Mitigation Strategy/Tools to be Used
Confidential – 20 Study Conduct Quality Management System-Sponsor Level Is there a sponsor level QMS in place, at the CRO/support company level, at the site level? Required Regulatory Reporting Does the sponsor have the infrastructure to support the required regulatory reporting needed? Does the supporting organization have the infrastructure? Does the site have a QMS or the essential quality controls in place? Specific Study Activities Informed consent process, enforcement of INC/EXC, handling protocol deviations/violations, stopping rules, SAE handling, dose modifications, etc. Investigational Product Is there investigational product in place to conduct the study, is there a re- supply process, is the supply chain establsied, are there regulatory risks for international studies/transport/storage of the investigational product? Safety Concerns Study participant protection and well- being processes/procedures in place, safety monitoring, know adverse evetns/reactions, process for documetnation and reporting of unexpected events and SAE's Study specific tasks Endpoints, complexity of the study, stage of the study, number of potential study participants and geographic availability
Confidential – Leverage Technological Tools – Focus on EDC ► CTMS Applications ► EDC Application • Platform – Trial-by-Trial Reporting Tools • Platform – Cross Study Managers/Filters/Reporting Tools • Performance/QualityTools ► Safety Application 21
Confidential – Reporting Quality – Leverage Technology Critical inToday’s Trials • Trial Data • Monitor Protocol Compliance/Deviations • Establish Qualification Standards/Specifications • Define Metrics to Allow Oversight – RBM • Frequency • SDV – Data Collection, Retrieval, and Reporting – Performance/Quality Measures
Confidential – Summary • Risk based approach starts in planning the program not the study • Know, Understand, and Use AvailableTools • Adapt protocol-by-protocol throughout the program – Learn as you go – Adapt as you go – Improve as you go • Communicate, communicate, communicate – Allow for sponsor and regulatory interactions
Confidential – Questions 24
Confidential – Contact Information ► Bill Gluck, Ph.D. • Bill.Gluck@DATATRAK.com ► General Questions about DATATRAK • Dorothy.Radke@DATATRAK.com ► Find Us Online • www.DATATRAK.com • http://www.slideshare.net/DATATRAK • @DATATRAKinc onTwitter • https://www.linkedin.com/company/datatrak-international 25
from Concept to Cure with DATATRAK ONE DATATRAK International Chicago, Illinois Cleveland, Ohio Bryan,Texas Cary, North Carolina United Kingdom 888.677.DATA (3282) Toll Free www.datatrak.com ® ®

More Related Content

Leverage Your EDC Solution to Mitigate Risk in Clinical Research

  • 1. LeveragingYour EDC Application to Mitigate Risk in ClinicalTrials March 25, 2015
  • 2. Confidential – Your Speaker ► Bill Gluck, Ph.D. • Dr. Gluck has over 30 years of expertise in clinical research, with experience in sponsors, CROs, and with DATATRAK in a variety of roles. Dr. Gluck is also the Program Director for the Clinical Trials Research and Medical Product Safety/Pharmacoviligance programs at DurhamTechnical Community College. Dr. Gluck earned his Bachelor of Science Degree at the University of Scranton and Master and Ph.D. degrees from North Dakota State University. 2
  • 3. Confidential – Our DiscussionTopics • Definition and Perception of ‘Risk’ • Risk-Based Quality Management • How Can We Mitigate Our Risk Profile – Approaches to Reducing Risk – Review, Report, Communicate – Leveraging Technological Tools • Summary
  • 4. Confidential – Every Clinical Trial Has Inherent Risk and Every Risk Has aTolerance Limit 4
  • 5. Confidential – Risk 5 Risk is an uncertain event or condition that, if it occurs, has an effect on at least one objective.
  • 6. Confidential – Mitigating Risk 6 Taking steps to reduce adverse effects.
  • 7. Confidential – Tolerance 7 There is no way a sponsor can eliminate all risks of doing clinical trials so defining the amount and identifying the type of risk that a sponsor is willing to accept helps them evaluate where resources should allocated to minimize the most significant risks.
  • 8. Confidential – Perception of Risk Role and Responsibilities – Sponsor – Investigator – IRB/Ethics Committee Member – Quality Representative – Regulator
  • 9. Confidential – Risk-Based Quality Management • Start with Quality – End with Quality – A systematic process to identify, assess, control, communicate, and review risks associated with the trial throughout the life of the trial
  • 10. Confidential – One Approach To Risk Mitigation Identify & Assess Control Review & Communicate 10
  • 11. Confidential – Identify and Assess Risk • Privacy Protection of Study Participants • Patient/Subject Safety • Quality/Reliability of Study Data
  • 12. Confidential – Controlling Risk • What decisions can be made to reduce and/or accept risk? • Where can we mitigate risk? • How can we accomplish this?
  • 13. Confidential – Review and Communication • Document your process • Communicate the process • Review results • Incorporate new information • Update and revise your plan as needed
  • 14. Confidential – Develop and Implement A Plan • Building on the answers – Develop a plan – Implement action for high risk – Understand there may be implications with low risk
  • 16. Confidential – How Do We Do This? • Separate prioritization from risk mitigation • Address each stage of the trial • Stratify/Customize the plan
  • 17. Confidential – Setting Boundaries – Early and Often • Trial Data • Monitor Protocol Compliance/Deviations • Establish Qualification Standards/Specifications • Define Metrics to Allow Oversight – Data Collection, Retrieval, and Reporting – RBM – Quality Measures
  • 18. Confidential – A Sample Template Header Categories Risk Area/Category Potential Risk Assessed Risk Examples/List study specific issues Include in Monitoring Plan (Yes/No) ToleranceThreshold Mitigation Strategies/Tools to be Used 18
  • 19. Confidential – Sample Template Header 19 Risk Assessment Worksheet Risk Area/Category Potential Risk Assessed Risk Examples (list study specific issues) Include in Monitoring Plan (Yes/No) Tolerance Threshhold Mitigation Strategy/Tools to be Used
  • 20. Confidential – 20 Study Conduct Quality Management System-Sponsor Level Is there a sponsor level QMS in place, at the CRO/support company level, at the site level? Required Regulatory Reporting Does the sponsor have the infrastructure to support the required regulatory reporting needed? Does the supporting organization have the infrastructure? Does the site have a QMS or the essential quality controls in place? Specific Study Activities Informed consent process, enforcement of INC/EXC, handling protocol deviations/violations, stopping rules, SAE handling, dose modifications, etc. Investigational Product Is there investigational product in place to conduct the study, is there a re- supply process, is the supply chain establsied, are there regulatory risks for international studies/transport/storage of the investigational product? Safety Concerns Study participant protection and well- being processes/procedures in place, safety monitoring, know adverse evetns/reactions, process for documetnation and reporting of unexpected events and SAE's Study specific tasks Endpoints, complexity of the study, stage of the study, number of potential study participants and geographic availability
  • 21. Confidential – Leverage Technological Tools – Focus on EDC ► CTMS Applications ► EDC Application • Platform – Trial-by-Trial Reporting Tools • Platform – Cross Study Managers/Filters/Reporting Tools • Performance/QualityTools ► Safety Application 21
  • 22. Confidential – Reporting Quality – Leverage Technology Critical inToday’s Trials • Trial Data • Monitor Protocol Compliance/Deviations • Establish Qualification Standards/Specifications • Define Metrics to Allow Oversight – RBM • Frequency • SDV – Data Collection, Retrieval, and Reporting – Performance/Quality Measures
  • 23. Confidential – Summary • Risk based approach starts in planning the program not the study • Know, Understand, and Use AvailableTools • Adapt protocol-by-protocol throughout the program – Learn as you go – Adapt as you go – Improve as you go • Communicate, communicate, communicate – Allow for sponsor and regulatory interactions
  • 25. Confidential – Contact Information ► Bill Gluck, Ph.D. • Bill.Gluck@DATATRAK.com ► General Questions about DATATRAK • Dorothy.Radke@DATATRAK.com ► Find Us Online • www.DATATRAK.com • http://www.slideshare.net/DATATRAK • @DATATRAKinc onTwitter • https://www.linkedin.com/company/datatrak-international 25
  • 26. from Concept to Cure with DATATRAK ONE DATATRAK International Chicago, Illinois Cleveland, Ohio Bryan,Texas Cary, North Carolina United Kingdom 888.677.DATA (3282) Toll Free www.datatrak.com ® ®