creating a comprehensive clinical trial management system

L AU R E N Y E S K O T H E E M M E S C O R P O R AT I O N

S C T 3 6 T H AN N U AL M E E T I N G C O N T R I B U T E D PAP E R S E S S I O N 1

M O N D AY, M AY 1 9 , 2 0 1 5 11 : 1 5 - 11 : 3 0 AM

Creating a Comprehensive Clinical Trial Management

System

National Institute on Drug Abuse (NIDA) Clinical Trails Network (CTN)

Multi-site, multi-protocol network to study interventions for the treatment of substance use disorders

The Emmes Corporation has a contract to serve as the Data and Statistics Center (DSC) and Clinical Coordinating Center (CCC) for the network

DSC – AdvantageEDC & Statistics Currently 10 active protocols in various stages

Background

Industry trend - integrate all components of managing a successful trial into one electronic system Regulatory tracking Protocol monitoring Inventory management Protocol deviation and Serious Adverse Event review Trial Progress Reports Automated Data Quality Reports

Goal: easy to implement, automate Build into EDC component when possible Program reports in SAS as backup

EDC for Regulatory Tracking

Document management system Protocol approvals, CVs, medical licenses, 1572s, FWA

Site staff upload directly, coordinating center staff review and approve

Tracks expiration dates Automatic email reminders

Reports available to track missing documents

EDC for Protocol Monitoring

Risk-based monitoring Uses Protocol Monitoring module of AdvantageEDC Easily identify what’s been monitored and what needs to be Monitor only a form-specific percentage of completed CRFs

100% - Safety data, eligibility 75% - Primary outcome 10% - Secondary outcomes Participants randomly selected for 100% data review

Update expectations based on site performance during trial Separate excel tracking tool for monitoring not documented in

EDC

EDC for Protocol Monitoring

Protocol Monitoring – Electronic Site Visit Report

Series of eCRFs completed by protocol monitor/CRAs Reviewed and locked by senior staff A number of fields are filled automatically based on previous

reports or data entered in EDC Number of participants randomized Number of forms/fields monitored and number of discrepancies

Protocol Monitoring – Electronic Site Visit Report

Site visit report generated automatically

Inventory Management

Automated study drug kits Can’t automate some

supplies due to inventory types and use that isn’t always captured on other forms Urine drug screens Pregnancy tests Lab kit shippers

Sites complete weekly inventory CRF in EDC Inventory and expiration date Items listed “by the box”

instead of individually Reminder e-mails

Supply inventory report Current Inventory & past 4

weeks Expiration dates and quantity

below threshold highlighted Thresholds can be site and

protocol specific Supply reorder report Site-specific reorder of

supplies Used to complete vendor

orders Vendor labels aren’t always

intuitive


Reorder report

Inventory

Protocol Deviation and SAE Review

3 eCRFs SAE determination

made by system Medical monitor

reviews SAEs directly in EDC

Communicates to research staff

Locks reviewed SAEs

Real-time review of PDs and trends

Trial Progress Reports

Posted to a password protected website Updated nightly Standard and protocol specific analyses Available to many Allows for greater transparency and clear expectations Defined performance metrics - color coded to easily and

quickly gauge study status and identify troubled sites Enrollment and follow-up rates Regulatory status Data quality (missing values, forms, audits)

Availability of primary outcome Treatment exposure

Trial Progress Reports

Data Quality

Automated monthly data quality reminder Missing values Missing forms Anomalies

Conclusions

Think beyond study data! Automate what you can Increased startup/programming time Saves time during the trial Reduces errors Easier identify and consistently categorize tends

Acknowledgements

This project has been funded in whole or in part with Federal funds from the National Institute on Drug Abuse, National Institutes of Health, Department of Health and Human Services, under Contract No. HHSN271201400028C

Thank you Dr. Paul VanVeldhuisen, NIDA CTN DSC Principal Investigator Eleni Bobys, Clinical Systems Analyst NIDA DSC Programmers Other members of the NIDA CTN DSC and CCC teams

Abstract

As Electronic Data Capture systems become more advanced, it allows the scope of trial data to expand to include administrative tools. In recent studies conducted by the Clinical Trials Network (CTN) of the National Institute on Drug Abuse, The EMMES Corporation, which serves as the Data and Statistical Center (DSC) for the network, has implemented a number of administrative functions to create a comprehensive clinical trial management system. Enhancements include a database to store and track expirations of regulatory documents, an electronic service or post-monitoring visit report, a study drug and supply inventory system, additional eCRFs that are available only to coordinating center staff to document review of Serious Adverse Events and Protocol Deviations, detailed reports to aid in central and risk-based monitoring, trial progress reports that are updated daily and available to anyone in the CTN, and automated monthly data quality reports. Coordination of the trials has greatly improved with the availability of these tools, resulting in a more efficient use of protocol monitor, protocol specialist, and data managers’ time. Adding the ability to easily identify and consistently categorize tends has also allowed the coordinating center to implement central and risk-based monitoring, and identify areas that require additional training across multiple protocols. These tools and how their implementation has impacted the coordinating centers and clinical sites will be discussed.

creating a comprehensive clinical trial management system

Documents