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VANDERBILT-INGRAM CANCER CENTER
CLINICAL TRIALS SHARED RESOURCES (CTSR)
Jennifer S. Novia
INFO 643
March 6, 2011
To alleviate cancer death and suffering through pioneering research;
innovative, patient-centered care; and evidence-based preservation,
education and community activities.
Vision
Values
To be the preeminent cancer center in the
Southeast and a recognized leader,
nationally and globally, in the effort to
prevent and treat cancers.
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Discovery and Innovation
Impact and Translation
Relationships and Collaboration
Service and Compassion
VANDERBILT-INGRAM CANCER CENTER
Mission
Research Nurses
Assistant Director of
Finance
Assistant Director,
Clinical Operations
Clinical Trials
Information Program
(CTIP)
CEO, VICC
Medical Director
Regulatory and Data
Management
Executive Director
Research Compliance
and Scientific Review
Analysis
Assistant Medical
Director
CLINICAL TRIALS SHARED RESOURCES (CTSR)
Information flows to the CTSR under the direction of the
Vanderbilt-Ingram Cancer Center CEO.
Preclinical
Animal or laboratory
studies that provide
information regarding
safety. Evaluation of
data determines
whether safety to
start human subject
clinical trials.
Up to
4.5 years
Phase I
Experimental drug or
treatment given for
the first time to a
small group (15-30)
to evaluate its safety,
determine a safe
dosage range, and
identify side effects
Phase II
Experimental study
drug or treatment is
given to a larger
group (30-100) to see
if it is effective and to
further evaluate
safety
Up to
8.5 years
Phase III
Experimental study
drug or treatment
given to large groups
to confirm
effectiveness, side
effects, compare to
common treatments,
and collect safety
information
Approval
After completing
trials successfully,
new drugs go to
market. Roughly 20%
of all new drugs that
enter Phase I trials
are approved for
marketing.
Up to
1.5 years
CLINICAL TRIAL PHASES
Drug toxicity and safety is imperative to Phase I clinical
trials. This evaluation of users and information gaps is
centered on the Phase I Clinical Trials Initiative of CTSR.
Cancer Center
• Patients
• Physicians
• Research Nurses
Secondary Information Users
Clinical Trials Shared Resources (CTSR)
• Clinical Trials Information Program
• Biospecimen
• Regulatory
• Data
External Users
• Institutional Review Board (IRB)
• Pharmaceutical Sponsors
• Food and Drug Administration (FDA)
INFORMATION USERS
Primary Information Users
Subject Safety
Primary investigators and research
nurses ensure subject safety by:
• Implementing the trial protocol as
written
• Adherence to inclusion and
exclusion criteria
• Continued adherence throughout the
study
• Monitoring subject status (subject
health, minimization of risk, toxicity
tracking and management, etc.)
SAFETY MONITORING
Safety monitoring is required in clinical trials to ensure
subject safety and study integrity. Drug level toxicities are
a key component of Phase I safety issues.
Formal Information Sharing
Informal Information Sharing
Formal information is gathered to assess
the viability of treatment options within the
clinical trials program at Vanderbilt
University. In the case of the CTSR, this
formal information is also used to assess
the safety and efficacy of new drugs.
Informal information is shared
spontaneously, is unofficial and has the
potential to be an impromptu way for
people to learn how to do their jobs and
impact patient care and new drug
development.
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Physical Examinations
Laboratory Tests
Diagnostic Imaging
Serious Adverse Effect (SAE)
reporting
• Associations in clinics
 Patient visits – health information,
potential side effects from drug
treatment
 Interactions between research
nurses and primary investigators
(physicians)
• Team collaboration
 Sponsor conference calls
 Phase I team meetings
INFORMATION SHARING
Formal and informal information have an impact on patient
care and moving new drugs through the pipeline to FDA
approval.
Information Gaps
Vanderbilt University School of Medicine
• Ten physicians who act as primary
investigators
Poor participation in weekly Vanderbilt
Toxicity Meetings by principle investigator
• Only four of ten principle investigators
participate
• Personnel issues have impacted
demands on research nursing staff
• Serious adverse effect (SAE) information
not documented by regulatory and data
personnel for notation in monitoring
records.
Vanderbilt-Ingram Cancer Center
• Program Coordinator
Clinical Trials Shared Resources (CTSR)
• Four research nurses
• Bio-specimen team
• Regulatory personnel
• Data monitoring and reporting personnel
Information Sharing on Drug Toxicities
• Weekly toxicities meeting
• Trial sponsor conference calls
• Informal exchange of information
Lack of knowledge transfer from sponsor
conference calls results in loss of
information regarding:
• External trial site information regarding
dose limiting toxicities and unexpected
toxicities in patients on the trial drug.
• Conference call information not properly
documented and shared with all staff.
This information is necessary for proper
patient care and diagnosis in the case of
a suspected adverse reaction.
• No formal reporting process to the CTSR
Medical Director
PHASE I TEAM AND INFORMATION GAPS
Phase I Team
Clinical
Trial
Sponsor
SAE
Compiled CRF
Resources
Patient Info.
SAE
Regulatory and Data
Management
Patient
SAE
EMR
Patient Info
Resources
Trial
Protocol
Patient
Data/Event
Resources
LEGEND
Directives
Workflow,
Processes
Patient Health Care Delivery
Cancer Care Clinics
Patient
Vanderbilt-Ingram Cancer Center
Health Care System
OnCore
Master File
Directives
Clinical Trials Shared
Resources (CTSR)
Overall trial management
CURRENT CLINICAL TRIAL DATA FLOW PROCESS
The current data flow model does not allow for the clear
exchange of toxicity information between the principal
investigators and staff.
Lack of assigned
ownership with
current process
No central
repository for
reporting
conference call
results
SAEs not
adequately
reported back
Decrease in
Information
Flow and
Patient Safety
PROBLEMS WITH CURRENT INFORMATION FLOW
Informal communications are hindered by the current
information process. Lack of reporting to a central point is
detrimental to the flow of information and has the potential
to impact patient safety.
Phase I
Clinical Trials
Toxicity Report
Reported
Toxicities
Pt. Info
Phase I Toxicity Meetings (Medical
Director, Regulatory & Data
SAE?
NO
YES
Institutional Review Board (IRB)
Protocol Modifications or Trial Warnings
Program Coordinator, Phase I
Clinical Trials Initiative
External
Trials Sites
External Trial
Patients
Unexpected
Toxicities
OnCore
Master File
Toxicity
Conference
Call Highlight
Patient
Information
SAE
EMR
Internal Principle Investigators and
Research Nurses
Vanderbilt-Ingram
Cancer Center
Health Care System
Clinical
Trial
Sponsor
LEGEND
Stop.
No further
reporting
required.
Data/Event
Resources
Directives
Workflow,
Processes
PROPOSED TOXICITY INFORMATION FLOW
Improved reporting procedures will increase the transfer of
information between sponsors and PI’s and Research
Nurses.
Phase I Conference Call Reporting
Study Name
Date of Conference Call
Dose Limiting Toxicities (DLTs)
Pertinent Dose Level Discussions
Unexpected Toxicities
Slots available for VICC
Further Comments
VICC MD/Staff on call
INFORMATION REPORTING TOOL
Conference call reporting form not only provides
information about safety but also provides planning
guidance to regulatory/data personnel for number of
patients that can be brought into the trial (slots available).
Sponsor
Information from other trial sites is
conveyed from the trial sponsor during
conference calls.
Principal
Investigator
or Research
Nurse
SAE information is transferred from the
Sponsor to Vanderbilt clinical staff directly
involved in trial management.
Program
Coordinator
Safety information is collected and
assembled in a reportable style by Phase I,
Program Coordinator.
Phase I
Business
Meeting
SAE information is discussed in business
meeting by clinical team and decisions
for further reporting or action are made.
RECOMMENDED PROCESS IMPROVEMENT
Improved reporting procedures will increase the transfer of
information between sponsors and PI’s and Research
Nurses.
Accurately reflect number of patient slots with
trial sponsor for screening/consenting patients
Convey safety issues from sponsor to
CTSR management
Create a centralized repository for SAE
information for historical purposes
MEASURING IMPLEMENTATION SUCCESS
Successful implementation of the conference call
reporting tool will: