VANDERBILT-INGRAM CANCER CENTER CLINICAL TRIALS SHARED
RESOURCES (CTSR) Jennifer S. Novia INFO 643 March 6, 2011
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V ANDERBILT -I NGRAM C ANCER C ENTER Mission To alleviate
cancer death and suffering through pioneering research; innovative,
patient-centered care; and evidence-based preservation, education
and community activities. Vision To be the preeminent cancer center
in the Southeast and a recognized leader, nationally and globally,
in the effort to prevent and treat cancers. Values Discovery and
Innovation Impact and Translation Relationships and Collaboration
Service and Compassion
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CEO, VICC Assistant Director of Finance Medical
DirectorExecutive Director Regulatory and Data Management Clinical
Trials Information Program (CTIP) Research Compliance and
Scientific Review Analysis Assistant Director, Clinical Operations
Research Nurses Assistant Medical Director C LINICAL T RIALS S
HARED R ESOURCES (CTSR) Information flows to the CTSR under the
direction of the Vanderbilt-Ingram Cancer Center CEO.
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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. C LINICAL T RIAL
P HASES 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 Experimental study drug or
treatment is given to a larger group (30-100) to see if it is
effective and to further evaluate safety Experimental study drug or
treatment given to large groups to confirm effectiveness, side
effects, compare to common treatments, and collect safety
information 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 Up to 8.5
years After completing trials successfully, new drugs go to market.
Roughly 20% of all new drugs that enter Phase I trials are approved
for marketing. Approval Phase III Phase II Phase I Preclinical Up
to 1.5 years
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I NFORMATION U SERS Primary Information Users Cancer Center
Patients Physicians Research Nurses 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)
Secondary Information Users
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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. S AFETY M ONITORING 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.)
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I NFORMATION S HARING Formal 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. Physical
Examinations Laboratory Tests Diagnostic Imaging Serious Adverse
Effect (SAE) reporting Informal Information Sharing 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.
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 Formal
and informal information have an impact on patient care and moving
new drugs through the pipeline to FDA approval.
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P HASE I T EAM AND I NFORMATION G APS Phase I Team Vanderbilt
University School of Medicine Ten physicians who act as primary
investigators 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 Information Gaps 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. 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
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C URRENT C LINICAL T RIAL D ATA F LOW P ROCESS Directives SAE
Patient Info Patient Resources Directives Patient Info. Resources
SAE Compiled CRF Clinical Trial Sponsor Clinical Trials Shared
Resources (CTSR) Overall trial management Regulatory and Data
Management Patient Health Care Delivery Cancer Care Clinics
Vanderbilt-Ingram Cancer Center Health Care System OnCore Master
File Trial Protocol SAE Patient Data/Event Resources Workflow,
Processes LEGEND EMR The current data flow model does not allow for
the clear exchange of toxicity information between the principal
investigators and staff.
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P ROBLEMS WITH C URRENT I NFORMATION F LOW 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.
Decrease in Information Flow and Patient Safety No central
repository for reporting conference call results Lack of assigned
ownership with current process SAEs not adequately reported
back
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P ROPOSED T OXICITY I NFORMATION F LOW Improved reporting
procedures will increase the transfer of information between
sponsors and PIs and Research Nurses. Toxicity Conference Call
Highlight Clinical Trial Sponsor Internal Principle Investigators
and Research Nurses Phase I Toxicity Meetings (Medical Director,
Regulatory & Data Vanderbilt-Ingram Cancer Center Health Care
System OnCore Master File EMR External Trials Sites External Trial
Patients SAE Pt. Info Unexpected Toxicities Patient Information
Institutional Review Board (IRB) Program Coordinator, Phase I
Clinical Trials Initiative Phase I Clinical Trials Toxicity Report
Protocol Modifications or Trial Warnings SAE? NO YES Reported
Toxicities Stop. No further reporting required. Directives
Data/Event Resources Workflow, Processes LEGEND
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I NFORMATION R EPORTING T OOL 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
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).
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R ECOMMENDED PROCESS IMPROVEMENT Improved reporting procedures
will increase the transfer of information between sponsors and PIs
and Research Nurses. Sponsor Principal Investigator or Research
Nurse Program Coordinator Phase I Business Meeting Information from
other trial sites is conveyed from the trial sponsor during
conference calls. SAE information is transferred from the Sponsor
to Vanderbilt clinical staff directly involved in trial management.
Safety information is collected and assembled in a reportable style
by Phase I, Program Coordinator. SAE information is discussed in
business meeting by clinical team and decisions for further
reporting or action are made.
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M EASURING I MPLEMENTATION S UCCESS Successful implementation
of the conference call reporting tool will: 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
