devotion - adventhealth research institute · devotion a time of great hope, change and...
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DevotionA Time of Great Hope, Change and Collaboration
Susan Dempsey-Walls, MN, CNS Cancer Research
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Every Standard of Care Therapy is Available Because of a Past Successful Clinical Trial
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The Power & Promise of Cancer Research
“A Time of Great Hope and Optimism”
ASCO 2018 Keynote Address
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Key to Success During Future Changes
If everyone is moving forward together, then success takes care of itself.
Coming together is a beginning,
staying together is progress,
and working together is success.
- Henry Ford
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NCI Strategy Project Clinical Research Celebration
Cancer Clinical Research Director Cancer Research Sr. Director
Translational Research Center
Investigational Drug Services
Clinical Research Nurses/Coordinators
Research Compliance/Regulatory
Research Assistants
Data Management
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David Moorhead, M.D.Chief Clinical Officer
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Better TogetherOffice of Research Integrity
Risk ManagementInterpreter Services
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Informed Consent and Non-English Speaking Subjects Guidance
• Ivette Leka - ORI• Michelle McKinney - IRB• Felipe Valerio - Qualified Bilingual Staff• Jessy Castillo - Interpreter Services
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• IRB• ORI• Research Departments• Interpreter Services• Risk Management
Collaboration
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• IRB policies and SOPs related to informed consent and documentation
• FH policies and procedures for Language and Communication
• Research Department response to Short-Form Survey
• Guidance for interpreter services
ORI and IRB Review
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Why Changes Were Needed?
• Lack of guidance of Short-Form use• Confusion of Short-Form use• Non-English population in Florida has
increased in 2017/2018• Low enrollment of non-English speaking
subjects - promote diversity
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Better Together
• Identified gaps, reviewed policies, and developed guidance.
• Providing clarity and guidance on use.
• Treating all subjects with fairness and respect.
• Making sure researchers are doing the process correctly.
Keep Me Safe Love Me
Own ItMake It Easy
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• HRP-802 Investigator Guidance- Informed Consent
• HRP-803 Investigator Guidance- Documentation of Informed Consent
• Short-Form Consent Templates
Changes to Current Guidance’s and Documents
Effective on 8/01/2018
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Added References • New Short-Form Guidance- HRP-804 • HRP-001- Definitions policy• FH SOP 010.024- Language access and
communication assistance
HRP-802 Investigator GuidanceInformed Consent
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HRP-803 Investigator Guidance Documentation of Informed Consent
Signatures• Short-form –
Subject and witness• Summary (Long
Form) - Personnel obtaining consent and witness
References• New Short-Form Guidance -
HRP-804 • HRP-001 - Definitions policy• FH SOP 010.024 - Language
access and communication assistance
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• Discontinue use of WIRB Short-Form consent templates
• Now using template with our FH IRB logo• Revised Short Form templates in 5 most
common FH languages• Spanish, Creole, Portuguese, Arabic and
Vietnamese• Available in IRBNet 8/1/18
Revised Short-Form Template
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Short-Form Consent Templates
Note: Interpreter cannot serve as witness
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New Guidance Documents/Templates
• HRP-804 Investigator Guidance- Short Form Consent Process in Research
• Quick Guidance - Short-Form Consent use in Research• Quick Guidance - Informed Consent Process for Non-
English Speaking Subjects in Research • Template - Informed Consent Checklist• Interpreter services guide for researchers
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HRP-804 Investigator GuidanceShort-Form Consent Process in Research
How many times can I use it?• No more than 3 times in the same language • After 3 times of use, it must be translated in that
languagePlease note that prior to starting a study, the enrollment of non-English subjects must be detailed in the protocol / supplement formIRB can request the ICF to be translated due to the complexity of study or at their discretion
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• What it takes to become a QBS?• How long it takes?• Benefits of becoming a QBS
Felipe ValerioQualified Bilingual Staff
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Contact: • ORI- [email protected], 407-303-8793• IRB- [email protected], 407-303-5581• Interpreter Services-
[email protected] Manager Office: 407-303-8768o In-Person Interpreter Same Day Appointment: 407-303-3025o Interpreter Services Office: Ext. 110-6707 or 110-6670
(Monday - Friday, 6AM - 4PM)
Questions
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Cancer ResearchSue Coakley, BS, MHA, CCRP
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Florida Hospital Cancer Institute Clinical Research
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Vision Statement: National recognition as a Cancer Institute that provides patients access to value-based, personalized care through highly specialized, comprehensive, and innovative destination programs.
Our program cares for more newly diagnosed cancer patients than any other
hospital system in Florida.*
More than 1,000 patients enrolled onto clinical trials
annually
Research affiliations with the National Cancer Institute (NCI), Children’s Oncology Group, and
University of Central Florida (UCF) College of Medicine
Accredited as an Academic Comprehensive Cancer
Program by the American College of Surgeons
Commission on Cancer
One of the most experienced radiation oncology programs in Florida and accredited by the
American College of Radiology (ACR) for quality
Performing more than 130 adult bone marrow transplants annually, and accredited by the Foundation for Accreditation of
Cellular Therapy (FACT) for quality
The world leader in robotic prostatectomy, utilizing Central Florida’s first da Vinci® Surgical
System
More than 10,000 cancer surgeries performed annually
Certified by the American Society of Clinical Oncology’s
(ASCO) Quality Oncology Practice Initiative for quality in
medical oncology
Accredited by the National Accreditation Program for Breast Centers (NAPBC) for
excellence in breast cancer care
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Medical Director Goals
Participate in clinical trials that will serve our patient population
Perform scientifically sound clinical trials that have the potential to change or complement the treatment of patients with cancer
Perform and report research data in an organized and systematic manner with the highest quality possible
Providing our research leaders the opportunity to publish and participate in National scientific and research forums
Carlos Alemany, MD
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Senior Director (1) Director (1)
Nurse Manager (1)
Disease Specific-Focus Nursing Team (8.5)
Administrative Specialist(1)
Regulatory Team (4)
Peds Onc Team (2)Rad Onc Coordinator (1)
BMT Team (1.5)Urology Practice (1.5)
Research Assistants (2)
Core Lab
Data Team (4)
Clinical ResearchMedical Director (1)
Contract/Budget Analyst (1)
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Last First Florida Hospital Position Higher Education
Degrees FL Dept of Health Licensure Research Certification IATA Year Started in Research Year started at FH
Year Started in Research at FH
Acker Ingrid Research Nurse BS, BSNRN
1 2016 2012 2016
Clise Lauren Research Nurse BSN RN 1 2016 2016 2016
Coakley Susan Director BS, MHA CCRP 1 1992 2012 2012
DiosomitoGyongyi Budget Specialist BS CCRP
20032003
2006
Fogg-Smith Stacy Research Nurse BSN RN 12016 2016 2016
Guyler SaraRegulatory Coordinator II
BS, MHA 0 CCRP2016 2016 2016
HardyKabreina
Clinical Research Assistant
RMA
1 2015 2015 2015
Hartley Kim Study Coordinator CMA1 2016 2005 2016
LeBlancJane
Research Nurse BS RN1
2000 1998 2000
MattixCorina
Research Nurse AS RN CCRC 1 2000 2010 2010
PortillaLilia
Clinical Research Coordinator MS 0 1981 2009 2009
Reinhart Barbara Clinical Research Assistant AA 0 1 2001 2001 2001
SamuelCini
Research Nurse BSN RN 1 2015 2006 2015
SellersKaren
Research Nurse BSN RN1
2012 2012 2012
Smith Jenni Research Nurse BSN RN 12016 2007 2016
Smith Jamie
Research Nurse BSN RN1
2015 2013 2015
SolerLourdes
Clinical Research Coordinator LPN CCRC 2006 2011 2011
StaffordDanyell
Clinical Research Assistant AS 2016 2016 2016
ThomasAndrea Research Nurse BSN RN 1 2017 2013 2017
Valerio
Felipe New Study Acquisition
DHA CCRC, CCRA 1 2007 2005 2007
WhaleyMorgan
Regulatory Coordinator II BS 2016 2016 2016
WhiteKaren
Clinical Research Coordinator CCRP 2000 2011 2011
Dempsey-Walls
Susan
Research Nurse Manager
MN, CNS, CNS, AOCNS
1 2018 2014 2018
Iorio
Rebecca
Regulatory Coordinator I
BS, MS
2018 2018 2018
GordonJasmine
Regulatory Coordinator IIBS
2015 2015 2015
PercyMelanie
Study Coordinator BS
1 2004 2018 2018
CrimminsCathy
Research NurseBSN RN; CPN
1 2018 2013 2018
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FHCI Offers Broad Portfolio of Novel Clinical Trials Across All Disease SitesBone Marrow
TransplantBreast CancerHead and Neck CancerGastrointestinal
Malignancies (GI)Genitourinary
Malignancies (GU)Gynecology Oncology
(Gyn Onc)Hematological
Malignancies
MelanomaNeuro-oncologyPediatric OncologyThoracicUrological (Early
Stage/Prevention)
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New Study Activation Process CDA
New Study Tracking Sheet & Reg Excel Master List Updated
Multidisciplinary Review; PI & Medical Director Protocol Review
Feasibility Questionnaire / Feedback Pharmacy/Infusion Room
Pre-Site Selection Visit
Cursory Budget Review Required to Complete PRC Submission Form
PRC Submission / Approval
Secure Study Manuals
Central Lab; Imaging; & Pharmacy
Coverage Analysis
Contract & ICF for Legal Approval
OSP Budget Review & Pre- Approval
Budget Negotiations with Sponsor
OSP Post-Review/Approval
Clinical Trial Agreement Executed
Regulatory Documents
IRB Submission (Central/Local)
Research Team Portal Access/Training
Site Initiation Visit
Sponsor Activation
Study-specific Tool Development
Treatment orders
Infusion Room Up/Down Sheets
Invoice Tracking Sheet
Coordinator NSC Log Sheet
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Collaborative Review of our New Study Activation Process
Thank you, OSP!
Shout out to Michelle Kilponen’songoing
support & guidance
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Screening/Enrollment Initiatives
• Multidisciplinary tumor boards
• Ongoing updates & educational slides to all investigators
• Open Protocol Study Listing by Disease Site (Fast Facts)
Team
• Disease Specific Protocol Review meetings
• Daily review of physician schedules
• Morning huddle or direct communication from provider
Protocol Champion • Phone
inquires/Referrals• FHCI Nurse Cancer
Care Coordinators (Navigators)
• Clinicaltrials.gov• FHCI Quarterly
Physician Newsletter
• Via Oncology
Awareness
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VIA: Promoting Clinical Research
Clinical Trials Presented on Pathways
Clinical Research Reporting
All locally open trials appear BEFORE the pathway treatment recommendation
If treating On Pathway, cannot bypass trial without indicating why trial will not be selected
Internal or external linksfor easy access to studydetails
• Trial selections by disease, presentation, physician and/or site
• Patient specific characteristic data to assist in pre-screening activities
• Patient counts by disease / presentation as well as physician / site (typically used to assess where to open trials)
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Clinical Trial View to End UsersOpen Trial – appears as first selectable option
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Thank You, Study Builders! Complication of oncology study designElements and events do not occur on same
dayRoutine care vs Non-Routine care can vary
by timepointClinical Validation Financial Validation Loading of back data Proactive use of CTMS once “go live” Supportive and open-minded teamIssue: multiple MRN#s for one patient
Collaboration with suggestions & questions
Building for future upgrades (“wish list”)
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Infusion Room & IDS Pharmacy Partnering
Create a scheduling appointment spreadsheet (duration of appointments for specific treatment days)
Clinical trial specific education: Creation of “Protocol Pointers” to provide education for infusion room staff
Infusion Staff Research “Basic Clinical Research” education
Infusion -related study deviations: incorporate deviation minimizing strategies
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Ongoing Collaborative Initiativesfor Success
CTMS
Infusion/IDSEducation
Via
FHMG
Collaboration
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Phase 1b Study of Oncolytic Vaccinia Virus GL-ONC1 in Recurrent Ovarian Cancer
Robert W. Holloway1, James E. Kendrick1, Amanda J. Stephens1, Jessica A. Kennard1, Jeremy Burt2, Jane LeBlanc3, Karen Sellers3, Jamie Smith3,
Susan Coakley3
1Gynecologic Oncology Program, Florida Hospital Cancer Institute; 2Department of Radiologic Services, Florida Hospital;
3Office of Clinical Research, Florida Hospital Cancer Institute, Orlando, FL 32804
ASCO Annual Meeting, June 1-5, 2018 – Chicago, IL
Protocol #: GL-ONC1-015; ClinicalTrials.gov Identifier: NCT02759588
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Abstract Brief Summary Background: Immunotherapy can trigger immune activation including tumor-infiltrating CD8+ T cells, leading to anti-tumor response and survival benefits. Immunotherapeutic GL-ONC1 (modified vaccinia virus (VACV)) causes oncolysis, immune activation and durable anti-cancer memory.
Methods: Intraperitoneal (i.pe.) infusion of GL-ONC1 monotherapy was given at high repeated doses in patients (pts) with platinum refractory/resistant disease.
Conclusions: Promising safety data, anti-tumor activity, and immune activation mechanisms were documented in this Phase 1b trial, and a Phase 2 trial (VIRO-15) is currently enrolling. Future studies combining GL-ONC1 and other immune therapies and/or chemotherapy are under consideration.
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Tumor Infiltrating Lymphocytes (TILs) Exemplary IHC analysis - pt. # 15A-06, with PFS of 71 weeks:Significant infiltration of CD8+ cytotoxic T cells into tumors after virus treatment indicates activation of immunosurveillance
baseline Week 36
CD3 CD8Baseline 2.94 0.58
Week 36 5.06 3.54
0
1
2
3
4
5
6
Cell
Coun
ts P
er 8
0x F
ield
Immune Cell Counts in Tumor biopsies
p<0.001
CD3+
CD8+
p<0.001
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Immune Modulation
Strong PD-L1 staining at the tumor-stromal interface
Baseline
GL-ONC1 Upregulates Immunomodulatory Target Proteins, such as PD-L1
20 days post-Tx
Acute inflammatory responses and PD-L1 upregulationin tumors by oncolytic virus GL-ONC1 can sensitize
tumors to PD-1/PD-L1 blockade.
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We are blessed with a great team….
Thank you to our research patients, friends and families!
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Cancer ResearchNathalie McKenzie, MD
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What We Are Doing and Where We Are Going?
1. Exciting Clinical trials currently open.2. Trials recently approved.3. Concepts in development.4. What can we be the best at?
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Exciting Clinical Trials Currently Open
STUDY NAME CANCER TYPE PRINCIPAL INVESTIGATOR
ANCERS-2 A Prospective, Multicenter, Observational Study Examining the Clinical Utility of CANscript in Routine Clinical Practice
Recurrent Epithelial ovarian cancer (EOC)
Nathalie Mckenzie, MD
Genelux—Phase 1b & 2 Study with GL-ONC1 in Patients with Recurrent OvarianCancer (VIRO-15)
Recurrent Ovarian Cancer Robert Holloway, MD
Xenetic -VX-EC-2-02: A Phase 2, Single Arm, Two Period Study of Sodium Cridanimod in Conjunction with Progestin Therapy in Patients with Endometrial Carcinoma
3rd Line Endometrial Cancer James Kendrick, MD
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Clinical Trials Recently Approved
IMMUNOTHERAPY
+
PARP INHIBITOR
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Targeted Agents Combined
IMMUNOTHERAPY(Nivolumab)
+
PARP INHIBITOR(Rucaparib)
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Concepts In Development
• Using novel treatment strategies to preserve fertility in young women diagnosed with GYN cancers
• New surgical techniques FPRT (Fertility Preserving Radial Trachelectomy)
• Use of neoadjuvant chemotherapy Search for best regimen
• New sophisticated radiation modalities IGBT (Image Guided Brachytherapy)
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Cervical Cancer: FPRT
Procedure:• Dividing the uterus
proximal to the cervical isthmus
• Excising the entire cervix and surrounding parametria
• Then suturing the uterus to the vagina
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Stretch Break
Stretch Break
Stretch Break
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Stand up
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Roll your neck
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Stretch your arms
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Twist your waist
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Sit down
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Cancer Vision & Strategic Update
Bryan Allinson | Senior Director
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Research Services Updates
OSP: Regina TanRAS: Michelle DolskeORI: Christina Jackson
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OSP Updates
• Institutional Clearance Requirements Reminder
• Updated Pathology Budget Worksheet• Grants Assignment Update• CTMS Update
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Institutional Clearance Required PRIOR to study initiation [HRP-010] Requirements:
Signed Research Review Application (RRA) Current Financial Conflict of Interest training and disclosures IRB approval and IRB-approved informed consent(s) Fully Executed Legal Agreements, as applicable
Clinical Trial Agreement (CTA), Grant award, other types of funding agreements
Material Transfer Agreements (MTA)/Data Use Agreement (DUA) Letter(s) of Agreement Physician Payment Letters for ancillary hospital services
Local MAC Approval Letter or Notification, as applicable Approved Internal Budget, if externally-funded Signed Coverage Analysis(es) or Billing Grid(s), if required
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Updated Pathology Budget Worksheet
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Grant Assignment Update
Audrey Carr Quilin Mars Leerin ShieldsCardiovascular Nicholson Center Cancer (Clinical) Diabetes Institute
Celebration Ortho Cancer (TRC) Radiology/Rad Onc
CREATION Pharmacy Children’s Research TRI-MD
CIE Thrombosis Surgery/ISA
Global Robotics Transplant
GME Urology
Neuroscience Women’s Health
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CTMS Update
Clinical Conductor Release 5.0 available July 17 Release notes coming soon
Departments LIVE Cardiovascular Research Neuroscience ResearchWomen’s and Ped’s Research Center for Interventional Endoscopy Cancer Research
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Research Services Updates
OSP: Regina TanRAS: Michelle DolskeORI: Christina Jackson
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Research Oversight Committee Update
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• Receives report from research team
• Determines serious and/or continuing non-compliance
• Disseminates information
IRB
• May give input r/t CAPA• Communicate summary of
serious and/or continuing non-compliance to ROC quarterly
• Communicate specific cases to ROC as requested on a case-by-case basis
Research Compliance
• Reviews specific cases as requested
• Reviews quarterly summary
• May add to CAPA
Research Oversight Committee
Research Oversight Committee Update
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DRAFT
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Thank you for attending!
Next meeting will be in September
or October