Panelists:

Joyce Niland, City of Hope (Moderator)

Warren Kibbe, Northwestern University

Jack London, Thomas Jefferson University

Aarti Vaishnav, University of Southern California

Umit Topaloglu, University of Arkansas for Medical Sciences

A Day in the Life of a City of Hope Protocol . . .

. . . Supported by Research Informatics

A researcher wants to design a new prostate cancer trial, and needs to answer the following questions:

Are there gaps in our prostate cancer research portfolio?

Are there trials already open that compete for the same patients as my new trial?

Do we see enough patients to enroll successfully onto this new trial in a timely manner?

Access secure area of CTOL. . .

New Protocol Intake Form (In Development)

There are no protocols currently open to accrual that compete

with these patient eligibility criteria.

There are 2 protocols currently open to accrual that compete

with these patient eligibility criteria: 01234 05678

Additional eligibility criteria that distinguish this protocol:

iCoDE*: Interactive Cohort Discovery Engine to Assist Investigators in Study Planning

*Fed by Enterprise Data Warehouse & based on i2b2 open source software

The new study is then scientifically and IRB approved. But it’s not ready to enroll patients (“activated”) until:

All contractual, investigational pharmacy, staffing, and information management components are in place

All reasons to hold the trial have been signed off in the inhouse MIDAS clinical research management system

An activation email is sent out to the research community

Informed consent is then available online from CTOL

&

The protocol is activated, and the search for eligible patients begins. The treating MD uses CTOL to determine studies that may match that person:

Enters core eligibility criteria responses for protocols available for that disease site

System eliminates all studies for which patient would not be eligible

Delivers a “short list”* of potentially eligible studies *List will be reduced to either 0 or 1 study once full

criteria within decision trees have been implemented

Clinical Trials On-Line to Facilitate Matching Patients to Protocols

If “active alert”,

message must

be viewed

before protocol

When ready to enroll and follow the patient, Research Informatics provides tools for:

Online retrieval of stamped consent form

Automatic withdrawal of signature consent if “hold on accrual” alert posted

Tracking of all consents, and levels of participation to which patient has agreed

Centralized registration of all patients going on study

Electronic data capture and data validation

When ready to enroll a

patient, must pull down

the most recent approved

consent from CTOL

Protocol consents are logged

including each participation

type, and by language

Entry of consent information launches automatic reminder to assigned staff to enroll patient in MIDAS within 24 hrs

Consents & Accruals Tracked within In-house

CTMS (MIDAS – Developed in 1989*)

* Migrating to Oracle’s Siebel Clinical CTMS

Electronic Data Capture (EDC) System: Medidata Rave (21 CFR Part 11 Compliant)

System Queries

“InTelescan” Scannable Forms for Disease Registries

While a patient is being treated on a highly experimental research trial, help to ensure their safety:

Notify caregivers that a patient is being treated on a trial

Provide access to information on prohibited meds

Alert staff when a patient has labs drawn, and provide results

Automatically grade lab-based AEs

Monitor engraftment for patients on transplant trials

Facilitating Patient Safety: MIDAS Integration with EMR

Automatically populated when “On Treatment” date entered in MIDAS (q 5 min)

Automatically removed when “Off Treatment” date entered into MIDAS

Integrated direct link into

study history in CTOL

Flag indicates whether protocol includes contraindicated drugs, links to online Pharmacy Summary

CONCOMITANT/ PROHIBITED MEDICATIONS:

Automated Email Alert for Lab-based AE Surveillance (CTCAE v4.0)

Generated

Q24 Hrs from

City of Hope

Enterprise

Data

Warehouse

Automated Grading of Lab-based Adverse Events

Niland, Stiller, Johnson, Neat,

Londrc, Johnson, Pannoni:

Improving patient safety via

automated laboratory-based

adverse event grading. JAMIA, 2012

Ensuring Patient Safety: Automated Engraftment Monitoring

Integrates data from EMR, blood bank & transfusion medicine via Enterprise Data Warehouse

Provide PI, study staff, and statisticians access to accumulating and final trial data:

Web-based portals for individual & aggregate study data

Clinical Research Portal for online reports and business intelligence

“Data lockdown” procedures have been instituted to curate and validate the final dataset for statistical analysis

Web-Based Query Tools – Individual Patient or Cohorts

Clinical Research Portal for Access to Data

Information Sciences Teams Led by:

Research Informatics

Ajay Shah

Sri Bolisetty

Gabe Peterson

Mike Change

Clinical Research Information Support (CRIS)

Adina Londrc

Susan Hmwe

Karen Rickard

Biostatistics

Jeff Longmate

Joycelynne Palmer

Paul Frankel

Rebecca Nelson