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Oncology Clinical Research

VIEWS: 10 PAGES: 38

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									          Oncology Clinical Research:
   Stumbling Blocks to Building Blocks

                                        Stacy Drew MS, CCRP
                                 Clinical Research Coordinator
                               Duke University Medical Center
                    Department of Surgery – Thoracic Oncology

Clinical Trials Management Systems Steering Committee Meeting
                                                    Rockville, MD
                                                October 19th, 2010
Agenda
   Duke Oncology Research
   Definition of CRA
   Top 5 CRA “Stumbling Blocks”
   Future Possibilities
   Questions
    Building Blocks
          CCOPs
•    CCOPs, Co-op Groups, SPORE, Industry, NCCN
•    NIH, OHRP, FDA
•    Trans Research, Bench to Bedside
•    Public Knowledge
•    CTSU, CTSA, NCI, CTEP
•    Genomics, Inv Initiated, Imaging, Pathology, Adverse Events, PHI




                                         INDUSTRY




                       Inv.
                    Initiated



          Pathology                                                     PHI
Building blocks pyramid

“..to deliver to the clinical research and care communities the ability to securely
     gather, exchange, explore, integrate, and reuse data and information within
     and among disciplines ..”




                                             Co-Op
                      NCCN       CCOPs                INDUSTRY    SPORE
                                             Groups


                  Inv.                           Adverse
                           Pathology   Imaging              PHI      Genomics
               Initiated                         Events
Duke Comprehensive Cancer Center
2009
   798 Oncology Protocols
   200 Industry Protocols
   200 Cooperative Group Protocols
   398 Investigator Initiated Protocols/“Other” Protocols (ex. QA projects,
    Database projects)

 Duke Thoracic Surgery/Oncology
    Investigator initiated (3-5)
    GSK (1)
    CALGB (3)
    ACOSOG (1)
    NCCN (QA Outcomes Research)
CRA Classification
•   CRA
          •   Clinical Research Nurse
          •   Data Manager
          •   Clinical Research Associate
          •   Clinical Trials Assistant
          •   Clinical Research Coordinator
          •   Nurse Clinician




                                                                CRA

                                              Clinical Research Nurse   Clinical Trials Assistant


                                                Data Manager            Clinical Research Coordinator

                                               Clinical Research Associate    Nurse Clinician
Top 5 CRA Challenges

1. Data Submission
     Clinical Data
     Correlative Science/Biospecimen research
2. Source documentation
3. Regulatory
4. Adverse Events
5. Data Queries
   Chart


Name       MRN     Time     Comments     OR Date    Serum   Brush   140202   140503   30506   GSK   Nodal
John Doe   XX000   8:00am   RUL nodule    2/17/09
                            1.2cm
Clinical Data
 Patient Registration (randomization)
    Institutional/local (Velos/eResearch)
    Co-operative group (CALGB, SWOG etc.)
    National (NCI, OPEN, CTSU, NCCN)
    Industry (GSK eN@ble, SBIR)
    Coordinator/local enrollment logs




                                              INDUSTRY
                                       NCCN
      Enrollment Log



                                                                                                     End
                                          Consent     Surgery     TX,F/U,                           Billing
    NAME       MRN    CALGB #     MD       Date        Date        OFF      DUE DATE      F/U        Date     COMMENTS
                                                                                        6/27/08-
Last, First   ZZ000   112222    D'Amico   5/29/2008   5/30/2008     f/u     8/22/2008   8/22/08               8/18/2008
                                                                                        11/20/07-
Last, First   XX000   104739    Harpole   5/3/2006    5/4/2006      f/u     5/20/2008    5/20/08              10/10/2008
Protocols Webpage
Patient Registration
Subject Creation
NCCN
Clinical Data

 Data Entry
    Fax/non-electronic data
         Imaging and reports, outside records, ICFs
     eCRF
     RDC
           e-N@ble (GSK)
           CTSU
           InForm
           Oracle clinical (RDC,CDM)
           Medidata RAVE (EDC, CDMS)
 Billing
                                                       INDUSTRY
    Grant charge reviews
    End billing date
                                           CTSU
Submission Schedule
CALGB On Study Form
CTSU Protocols Page
Study Phase
Demographics Example
     Correlative Science/Biospecimen


Sample        Institution
procurement  log/track..??  Notification  Shipment  Received..??
 Sample Procurement  Institution log/track  Notification  Shipment  Received…??




                          Supplies
                          Shipping
                          Time sensitive
                          Local lab facilities

                                                                                      INDUSTRY
CALGB Shipping example
Source Documentation
 EMRs vs. paper
 Multiple systems w/in institution
    PACS (Imaging)
    E-Browser (EMR)
    Peri-Op
    IDX (Schedule)
    Velos/eResearch (Billing)
    eIRB
    Aria (Meds)
 Institutional data vs. protocol required data
    Staging criteria
    Lab values

                                                     Inv.
                        INDUSTRY                  Initiated
Regulatory

 RSS/WIRB/Local Institution
 eIRB vs. Paper/Reg. Binders
 Institutional requirements vs. Sponsor/Co-op Group **
 Amendments
    IND/SAE Broadcast
    Protocol deviations
 Renewals
    Enrollment logs/pt. update



                                                 INDUSTRY




                                                       Inv.
                                                    Initiated
Duke Approved Webpage
Adverse Event Reporting

 Broadcast SAE
 FDA IND Safety Reports
 AdEERS
    CTC/CTCAE
 Local Institution
    Unanticipated problems
    Protocol violations
 Industry
    Differentiating causality – IND vs. SOC
    Con. Meds
                                               INDUSTRY
    Intensity
Duke IRB Screenshot
Standard SAE Collection / Reporting period for
Standard Protocol v13

•   Study Start Inform Consent
     • SAEs related to study participation (ex study procedure)
     • SAEs related to any concomitant GSK drug
     • Fatal SAEs
•   First Dose of study vaccine
     • Non-related SAEs (going through x days after last dose)
     • Related SAEs (going through Study end)
RDE2Oceans: investigator has full access

•   Investigator (Site) 
     • Data Entry  e-N@ble 
        • Upload Oceans Distributed Reports  NSCs (LOCs)  Local Regulatory
          Authorities  Distributed Reports
        • E-mail  Monitors
        • E-mail GSK Protocol Contact (LOCs)
        • E-mail  NSCs (LOCs)
        • E-mail  Clinical Safety BCSP
Serious Adverse Event Details
Data Queries

 Incorrect/incomplete
 Delinquent/Missing data
    Long term f/u**
 Repeatedly submitting the same data
 Queries 2-3 years after original submission date
 Query format varies…
    Co-op (fax)
    Industry (electronic, logic checks)
    Local (email)
    CTSU website (email)
                                                 INDUSTRY



                                                        Inv.
                                                     Initiated
CALGB Query
   Survival Status


IPEC:
    Clinical Trials Support Unit




   Must be listed as a data manager (DM) to receive email notifications
   Check website regularly for received and delinquent data
   Some studies post queries without email notification
Long Term F/U


 Patients leave institution to local f/u
    Outside facilities refuse to release data
 Lost to f/u
 Pt. death
    Social Security Death Index
    Cause of death…??
 End billing date
 SSDI  EMR  Clinical Trials …??  End Billing Date


                                               INDUSTRY




                                                     Inv.
                                                  Initiated
Future possibilities…??

   Improved RDC/CRF capabilities to reduce queries...
   Coordinate IND/SAE broadcasts….
   Coordinate specimen shipping/tracking….
   Study pt. self reported f/u…
   Coordinate protocol and billing schedules…
   Collaborate w/ tumor registries…
   Automatic data uploads from EMR  CRFs…
   Electronic informed consents…. linked to EMR and protocol
    registration…
CRA Affiliations

 SoCRA – Society of Clinical Research Associates
    http://www.socra.org/

 ACRP – Association of Clinical Research Professionals
    http://www.acrpnet.org/

 MAGI - Model Agreements & Guidelines International
    standardizing best practices for clinical research operations, business
     and regulatory compliance
    http://magiworld.org/
End Slides

								
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