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Vanderbilt-Ingram Cancer Center Clinical Trials Shared Resources (CTSR). Jennifer S. Novia INFO 643 March 6, 2011. Mission. - PowerPoint PPT Presentation
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VANDERBILT- INGRAM CANCER CENTERCLINICAL TRIALS SHARED RESOURCES (CTSR)
Jennifer S. NoviaINFO 643March 6, 2011
VANDERBILT-IN
GRAM CAN
CER CENTER
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
CEO, VICC
Assistant Director of Finance
Medical Director Executive 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
CLINICAL TRIALS SHARED RESO
URCES (CTSR)
Information flows to the CTSR under the direction of the Vanderbilt-Ingram Cancer Center CEO.
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.
CLINICAL TRIAL PHASES
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
To Market
INFO
RMATIO
N U
SERSPrimary 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
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.
SAFETY MO
NITO
RING
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.)
INFO
RMATIO
N SHARIN
G
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.
PHASE I TEAM AN
D INFO
RMATIO
N GAPS
Phase I TeamVanderbilt 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 GapsPoor 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
CURREN
T CLINICAL TRIAL DATA FLO
W PRO
CESSDirectivesS
AE
Pat
ient
Info
Pat
ient
Res
ourc
esD
irect
ives
Pat
ient
Info
.
Res
ourc
es
SA
E
Com
pile
d C
RF
Clinical Trial
Sponsor
Clinical Trials Shared Resources (CTSR)
Overall trial management
Regulatory and Data Management
Patient Health Care DeliveryCancer Care Clinics
Vanderbilt-Ingram C
ancer Center
Health C
are System
OnCoreMaster File
TrialProtocol
SAE
Patient
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.
PROBLEM
S WITH CU
RRENT IN
FORM
ATION
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.
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
PROPO
SED TOXICITY INFO
RMATIO
N FLO
WImproved reporting procedures will increase the transfer of information between sponsors and PI’s and Research Nurses.
Toxi
city
C
onfe
renc
e C
all
Hig
hlig
ht
Clinical Trial
Sponsor
Internal Principle Investigators and Research Nurses
Phase I Toxicity Meetings (Medical Director, Regulatory & Data
Vanderbilt-Ingram
Cancer C
enterH
ealth Care System
OnCoreMaster File
EMR
External Trials Sites
External TrialPatients
SA
EP
t. In
fo
Une
xpec
ted
Toxi
citie
s
Pat
ient
In
form
atio
n
Institutional Review Board (IRB)
Program Coordinator, Phase I Clinical Trials Initiative
Phase I Clinical Trials
Toxicity Report
Pro
toco
l Mod
ifica
tions
or T
rial W
arni
ngs
SAE?NO
YES
Rep
orte
d To
xici
ties
Stop. No further reporting required.
Directives
Data/Event
Resources
Workflow, Processes
LEGEND
INFO
RMATIO
N REPO
RTING TO
OL
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).
RECOM
MEN
DED PROCESS IM
PROVEM
ENT
Improved reporting procedures will increase the transfer of information between sponsors and PI’s 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.
MEASU
RING IM
PLEMEN
TATION
SUCCESS
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
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