Innovation in Adjudication A Case Study

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Dylan Patrick
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1 Innovation in Adjudication A Case Study Gail Arias, RN Director, Endpoint Adjudication inventiv Health, Clinical Division Svetlana Gorodetsky VP Sales, IBM Watson Health, eclinical IBM Clinical Development

Our clients Continue to evaluate Adjudication data to support Event Adjudication Data Safety Monitoring determinations FDA reports of safety and efficacy Reliance on multiple systems to facilitate

2 Our clients Continue to evaluate Adjudication data to support Event Adjudication Data Safety Monitoring determinations FDA reports of safety and efficacy Reliance on multiple systems to facilitate interim analysis Engaging adjudication in a clinical database Expertise may rely on multiple vendor involvement Separate clinical adjudication Data Transfers Biostatistician Review, SAS Transfer and Analysis Conceptual Data Incorporation - Support of more than Endpoint reporting - Defining key data to support preliminary analysis in real time

3 Case Study Small Biotech Firm Cardiovascular Indication Heart Failure - NYHA Classification II/III Double Blind Study Randomization 1:1

Challenge Sponsor Transition Revision of Event Definitions Data Collection Tools for Analysis Clinical Database Randomization Data (Establish Treatment Day) Core Labs - ECG, ECHO, Clinical Lab,

4 Challenge Sponsor Transition Revision of Event Definitions Data Collection Tools for Analysis Clinical Database Randomization Data (Establish Treatment Day) Core Labs - ECG, ECHO, Clinical Lab, Angiography Adjudication Database How do we monitor data related to Futility Analysis in Real Time without: Waiting for analysis of multiple data transfers Review / Closure of queries in multiple databases Reliance on clinical monitoring for clean data

Clinical Labs LVESD Adjudication Data Patient Centric Data

5 Strategy Data Transfers Clinical Database Parameters of Interest Randomization / Subject Treatment Core Lab Data Clinical Labs LVESD Adjudication Data Patient Centric Data for CEC Presentation Categorization of Events for ease of analysis

Accomplishing the Task - Understanding of Interdepartmental Communication, Responsibilities and Timelines without agreement of supportive role - Clinical Operations - Data Management

6 Accomplishing the Task - Understanding of Interdepartmental Communication, Responsibilities and Timelines without agreement of supportive role - Clinical Operations - Data Management - Biostatistics Review - Direct Responsibility - Communication with Site Research Staff - Direct Query - Data Transfers - Adjudication Platform Programming - Programming Report Output

7 Metrics, Risks and Challenges Adjudication Metrics Creation of Event to Final Source Receipt 32.6 days Days to Adjudication Results 40.2 days (7 outliers ~100 days average) Request for Additional Documentation 2.25 % Site Responsiveness Query Response Time Request for 3 day response time for query resolution Upload of Source 166 of 355 events required 2 nd upload from site Source usually was presented from outside institution

8 Data Analysis Output EAM # Subject ID NYHA CRT NT BNP Baseline LVESV Investigator AE Term Index Cath Day Zero Event Hosp Decomp Heart Failure (1) Heart Failure 01-JUL-2015 Resucitated Cardiac Death (1) Resucitated Cardiac Death (3) Ventricular Tachycardia Ventricular Tachycardia with successful antitachy pacing 01-JUL JUL Aug Oct Hosp Decomp Heart Failure (1) Hosp Decomp Heart Failure (2) Acute on Chronic Systolic Heart Failure Acute on Chronic Systolic Heart Failure 01-DEC DEC-2015 DATE of Event per CEC Study Day CEC Adjudication 13-AUG Negative 26-OCT RCD - VT/LOC 05-DEC ESI - Paced Conversion 17-DEC HDHF 28-DEC HDHF

9 Case Study Outcome and Benefits Ability to review preliminary data with reference to key parameters in one setting Trends Programming flexibility of the Adjudication Platform With Certified Programmers in house Cost and Time Efficiency

10 THANK YOU To the Staff at inventiv Adjudication Team Clinical Operations Data Management Biostatistics IBM Watson Health Training Support Business Development

Considerations for the future What is the future of adjudication services? Is the skill set of the Adjudication Staff changing to meet future trends?

11 Considerations for the future What is the future of adjudication services? Is the skill set of the Adjudication Staff changing to meet future trends? How does our electronic adjudication platform development fit into the future? Adjudication Platform Reporting and Analytics Support of Real World Evidence Risk Based Monitoring Tool for Source Review

12 IBM Clinical Development Solution Advancements Q Roadmap Custom Dossier upload Adapt to Study diversity Simplified Endpoint Adjudication Rule configuration o Enabling clients independence/control o Faster/easier configuration More workflow flexibility Additional phases QC process enhancements o Automated event selection

13 IBM Clinical Development Solution Advancements (continued) Beyond Q Watson for Patient Safety o Leveraging Cognitive functionality post upload of source document Read/parse attachment Trend detection (information, event seriousness, etc.) Facilitate document review Facilitate adjudication highlight critical data directly from document Increase Dossier creation efficiency Enhance RAD Process (e.g. is the autopsy report really provided for a reported death event) Enable decision making (i.e. based on all information, it meets the definition of an MI) NLP and Learning

14 Gail Arias, RN inventiv Health Svetlana Gorodetsky IBM Watson Health For the latest on IBM Clinical Development and our transformation story, follow us on LinkedIn and visit us at,

Data Management in Support of A Clinical Event Committee (CEC) Colleen M. Cox DIA Data Management March 20, 2002

Data Management in Support of A Clinical Event Committee (CEC) Colleen M. Cox DIA Data Management March 20, 2002 Study Parameters 2000 patients 150 sites 15 patients per site Phase IIIB Primary Endpoint: