scdm 2017 annual conference sdv what is it good · pdf filescdm 2017 annual conference ......

SCDM 2017ANNUAL CONFERENCE

September 24-27 I Orlando

SDV – What Is It Good For? Absolutely Nothing!

MaryAnne Rizk, PhDVP – Global CRO BioPharma PartnershipsOracle Health ScienceFollow: @RizkManagement #SCDM2017

01.SDV – What Is It Good For? Absolutely Nothing!

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TABLE OF CONTENTS

Saying Goodbye to SDV

Methods: Risk Management Planning

Technology: Strategies to Improve Data Quality

Clinical Outsourcing Impactsv

Key Risk Indicators (KRIs) and risk analysis

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Say Goodbye to SDVSource Data Verification – Expensive Comparison

1http://www.kalagathos.com/michaelherschelsheresies/michaelherschelsourcedataverification/

30% Clinical Trial Costs spent on 100% SDV

$7.5Billion

Annual Spent of Clinical Trials

100% = 0 value

$2B spent on 100% SDV has little impact on clinical trials

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Industry Risk Maturity


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Considerations Risk Based Monitoring


• Does your present Electronic Data Capture system have ability to track data

to be verified?

• How are you determining study-level risk?

• How are your risk tools integrated, and who performs maintenance on these

tools?

• Who mediates the decisions for risk mitigation?

• Technology must go hand-in-hand with Business Processes evolution and

Change Management

• Collaboration among all areas is key to success

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Risk Management –

An Intergreated Data Approach


• All sites shouldn’t be treated the same, leveraging data

transparency, do you have a method of blinding site-based

quality performance?

• Use intelligent monitoring, leveraging predicative analytics to guided targeted monitoring and put resources on data quality efforts where errors are likely to occur

• Leverage a single source to centralized Data Management within a Cloud Workbench Solution; allowing better data control for sponsors, provide transparency across clinical collaborators and eliminate data transportation

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Sponsor Approach on RBM Technology

& Clinical Outsourcing CRO Impact


“Clinical teams will be able to access study data through Oracle's single platform cloud service, eliminating the need to send data back and forth to CROs, saving us time and reducing the cost of our clinical studies,” -Rob Goodwin, VP Pfizer

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Key Drivers for RBM through technology

Only 2.4% of all queries generated concerned critical data

Quality focus

• Site and data

• Increasing safety

Advance technology to streamline drug development

• Getting more drugs to market to help patients

R&D pipeline

• Reducing risk for financial investment

• 10 to 40% cost savings needed over the next 3 to 5 years

• Travel cost

• Resource cost

• Site time

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Replace SDV with More Efficient Technology Solutions

• EDC: The eCRF can fill the need of the source document.

While regulatory bodies require that SDV be performed, there is no specification

regarding the amount of data required. The level of SDV is decided by each sponsor

based upon the level of risk to the accuracy of the data they can manage without

impacting safety and timelines, as well as what downstream risk mitigation processes

are in place.”

• CTMS: Sponsors identify fields or CRF modules that have a

high rate of SDV correction.

This may show where additional site training or a redesign of the CRF or source

documents may be needed. It will also focus on where continued high rates of SDV

should be applied. When fields or CRF modules that have lower SDV correction

rates are identified, the sponsor can reduce the level of SDV performed without

incurring an increased risk of errors. This can be applied to current or future

programs, maximizing the reduced SDV benefit.” 2

2 https://www.emc.com/collateral/emc-perspective/h5621-process-optimiz-ep.pdf

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Agency Guidelines are Changing

“One hundred percent SDV, the comparison of each data point on every case report form (CRF) to

subject medical records, may not be appropriate for most large, multi-center trials. Targeted SDV—

the verification of critical trial data, including study endpoints—has the potential to improve safety

oversight, data quality, regulatory compliance, protocol adherence, and overall trial validity while

reducing costs and the time to database lock for large, multi-center trials.”

“The Guidance on Good Clinical Practices (GCP), developed by the International Conference on

Harmonization (ICH), requires that trial monitors have access to and can review source documents.

This guidance, ICH E6, has been adopted by both the Food and Drug Administration (FDA) in the US

Code of Federal Regulations (CFR) under Title 21 and by the European Union (EU) as part of the EU

directive on clinical trials. Guidance ICH E6 and the regulatory authorities that have adopted it, refer

to source documents (i.e., primary health records, in the sections on investigators, sponsors, trial

protocols, and essential documents).”

“FDA guidelines explicitly refer to a representative number of subject records, not all subject records.

The Department of Health and the Medical Research Council in the United Kingdom announced,

"verifiable...does not imply that every item of data recorded must be supported by a source

document or checked."7 The number of subjects, the experience of the clinical site, the clinical

endpoints, and the nature of ancillary data are several of the factors that should be considered when

developing a strategy and protocol for a project-specific SDV plan.” 3

3 http://www.appliedclinicaltrialsonline.com/targeting-source-document-verification

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Considerations for Reducing SDV using a Risk-Based Monitoring (RBM) Strategy

• Does your present Electronic Data Capture (EDC)

system have ability to track data to be verified?

• How are you determining study-level risk?

• How are your risk tools integrated, and who performs

maintenance on these tools?

• Who mediates the decisions for risk mitigation?

• Technology must go hand-in-hand with Business

Processes evolution and Change Management

• Collaboration among all areas is key to success:

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RBM Industry Investments

CROs and sponsors investing millions to implement RBM

• Standardizing data and processes

• Creating Key Risk Indicators (KRIs)

• Operational focused (TransCelerate)

• Infancy in what is working and what is not.

• Introducing new business process and change management

• Business Intelligence (BI) tools

• Integrating systems and data – platform approach

New focus

• Focus on data quality algorithms, not just operational data

• Business process management tools

Future focus – Getting smarter with the data

• Artificial intelligence

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Multi-System Solution Supports All 5 Stages of RBM

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RBM Support – CTMS, Analytics (CDA), & EDC

RACT - CTMS

• Support Risk Assessment and Categorization Tool (RACT) features from TransCelerate within Clinical Trial Management System (CTMS)

• Use of ‘Assessments’ feature in Siebel

• Assessment template applied at various levels

Key Risk Indicators - CDA

• TransCelerate Key Risk Indicators added to Clinical Development Analytics (CDA) data model

• Out of the box dashboards at the Study and Study-Site level

Partial SDV Support – CTMS/EDC• Identify critical visits and pages

• Set partial SDV strategy at various levels

• Define criteria for SDV based on subject statuses/events

• Import SDV rules from InForm

Training Planning & Tracking for Sites - CTMS• Define Training Topics & Plans

• Track Training at Various Levels

Issue Management – CTMS• Record RBM mitigations and actions

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RBM Summary

CROs and sponsors investing millions to implement RBM

• Standardizing data and processes

• Creating Key Risk Indicators (KRIs)

• Operational focused (TransCelerate)

• Infancy in what is working and what is not.

• Introducing new business process and change management

• Business Intelligence (BI) tools

• Integrating systems and data – platform approach

New focus

• Focus on data quality algorithms, not just operational data

• Business process management tools

Future focus – Getting smarter with the data

• Artificial intelligence

scdm 2017 annual conference sdv what is it good · pdf filescdm 2017 annual conference ......

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