EPharma day munich - RBM with EU Clinical Trials Regulation
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Transcript of EPharma day munich - RBM with EU Clinical Trials Regulation
EPharma Day, Munich
11th of June 2015
Artem Andrianov, PhD, MBA
How to master the new EU Clinical Trials Regulation
with RbM?
Quality by Design Concept
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Desired Product Perform
ance
Product Design
Process Design
Process Perform
ance
Quality
by
Design
• Product Specifications• Product Quality Attributes• Process Parameters• Process Controls
• Continuous Improvement
• Product knowledge• Process understanding
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Duality of RbM definition: EMA vs FDA
RbM - is an important part of
a preventive clinical trial management.
RbM - is the adequate mix of strategies
including centralized and on-site monitoring
practices
„Both show the target, but do not describe the way“
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Pharma Mega-Trends
•Go-global in pharma
•Cost pressure -> Outsourcing
•Cost pressure again
•Personalized medicine
•Diagnostic-accompanied medicine
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New EU Regulation
Overview
New EU Regulation does not take any direct reference on RbM
Both should produce data of enhanced quality where it really counts
RBM should be a tool in that process, but it isn’t the only one – QbD is essential to maximise the gains from our new clinical research environment
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Both have the same key principles: interest of subjects has the ultimate priority over all other interests.
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• Two primarystudy objectives
• Inclusion and exclusion criteria verification
Risk-adaptive Protocol
• KRIs & KPIs & KQIs
• ValidationRBM plan
• Risk Monitoring
• Risk Preventing and Reacting
Operative Risk
Management
RbM Components
How RbM works?
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Definition of Key Risk Indicators
Protocol for a Risk-Adaptive Approach
Site Monitoring Plans
• Which data points can be verified centrally?
• How decision algorithm is defined when data are outside the design space?
RBM in Clinical Trial
• Statistical monitoring
• Integration process
• Risk indicators validation
• Validation of the protocol
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New Clinical Trial Regulations Key Principles
Transparency
• New publicly accessible EU clinical trials register
• Summary of the CT results must be published within one year
• Understandable outcomes should be published for layperson
• Clinical Study Reposts – publically available
Simplicity
• Streamlined application procedure
• Single set of documents
• Simplified reporting procedures
Speed-processing • Deadlines for the assessment of clinical trial application
Patient Safety• Involvement of the ethics committees in the assessment procedure
• More detailed Informed Consent requirements
Harmonization• Clinical trials conducted outside the EU, but submitted in an application
for marketing authorisation in the EU, they have to follow the new guideline
Data Quatliy • Data captured during a clinical trial must be trustworthy and robust.
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Here risk management can help
Risk Management For New Clinical Trial Regulation
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Data connection to EDC, CTMS and other clinical trial recording systems helps in applying the KRIs relevant for regulation
KRIs
Deadlines: reporting about
(S)EAs
Compliance with the protocol
Safety RecruitmentFraud &
sloppiness detection
Reliability and robustness of
the data generated
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KRIs for patient’s safety
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Informed Consent signature time and rightness
Recruitment, appropriate population
AEs, and SAEs, safety under-reporting
Data quality and robustness of data (Key Quality Indicators)
Wrong accompanying therapies or absence of a therapy, when it should be the case
Pharma Mega-Trends
•Go-global in pharma
•Cost pressure -> Outsourcing
•Cost pressure again
•Personalized medicine
•Diagnostic-accompanied medicine
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Case Studies
Case Study 1: Control over the (S)AE underreporting
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Safety Risk over 60%
Lower Number of AEs for a site
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Trail Details:• Sponsor: AstraZeneca• Area: Oncology Phase III, Randomised, Placebo-controlled• Double-blind Study for Prostate Cancer Patients. • 670 Patients • 253 Sites
Case Study 2: Low Performing Sites
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Low Performing Sites
Anomalies in Unscheduled Visits
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Trail Details:• Sponsor: AstraZeneca• Area: Oncology Phase III, Randomised, Placebo-controlled• Double-blind Study for Prostate Cancer Patients. • 670 Patients • 253 Sites
Case Study 3: Low Data Quality
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Site with much data submitted (size of the bubble) and poor data quality.
“Data normality test” shows that data is not normal-distributed.
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How Robust an Indicator?
Key Risk Indicator is effective only if it is:•Reliable
•Pro-active (so called “leading indicator”)
Alarm! + CAPA
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Key ‘take-away’ messages
The new EU Clinical Trials Regulation:
underlines patient safety,
simplifies the trial registration process and
increases data transparency.
data captured during a clinical trial must be trustworthy and robust.
The controlling of the data robustness can be delegated to a data driven RbM
It is essential to start gaining experience already now – you gain an important competitive advantage.
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Contact Us
Tel: +49 (0) 6192-470-113-50
Email: [email protected]
Web: www.cyntegrity.com
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