Post on 26-Mar-2018
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 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?
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
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
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
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
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
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