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Minimum Standards and Exemplary Attributes of Clinical Trial Sites

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Minimum Standards and Exemplary Attributes of Clinical Trial Sites S. Gail Eckhardt, MD (Slides prepared by Robin Zon, MD) – PowerPoint PPT presentation

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Title: Minimum Standards and Exemplary Attributes of Clinical Trial Sites


1
Minimum Standards and Exemplary Attributes of
Clinical Trial Sites
  • S. Gail Eckhardt, MD
  • (Slides prepared by Robin Zon, MD)

2
2008 JCO Special Article ASCO Research Committee
  • Minimal Standards
  • Exemplary Standards
  • Clinical Trial Portfolio Diversification
  • High Accrual (gt 10)
  • Participation in Clinical Trial Process
  • Formal Maintenance of High Education Standards
  • Quality Assurance
  • Multidisciplinary Care
  • Clinical Trials Awareness

3
Trial Site Minimal Standards
  • Compliance with International Conference on
    Harmonisation (ICH) Good Practice Guidelines
    (GCP)
  • Defines design, conduct, recording, reporting
    of human clinical trials.
  • Site specific Standard Operating Procedures
    (SOPS)
  • Human subject training by all investigators

4
Suggested SOPS (Examples)
  • Preparation maintenance of SOPS training on
    SOPS
  • Adverse event reporting
  • Clinical study operations
  • Managing clinical study supplies
  • Communication documents
  • Data Management
  • Quality Control
  • Recruitment Methods
  • Regulatory documentation
  • Sponsor interactions
  • Drug accountability storage
  • Coordinator selection, qualification, training,
    responsibilities
  • Informed consent
  • Investigator agreements
  • IRB approval operations of trials
  • Pre-study requirements
  • Protocol handling, review of feasibility,
    approval
  • Close-out study activities
  • Study confidentiality
  • Chart storage
  • Scientific misconduct policies and procedures

5
Seven ASCO Exemplary Clinical Trials Site
Attributes
  • 1. Clinical Trial Portfolio Diversification
  • 2. High Accrual (gt 10)
  • 3. Participation in Clinical Trial Process
  • 4. Formal Maintenance of High Education Standards
  • 5. Quality Assurance
  • 6. Multidisciplinary Care
  • 7. Clinical Trials Awareness

  • (Zon R, et.al., JCO 5/20/08)

6
Exemplary 1 Clinical Trial Portfolio
Diversification
  • Treatment and Prevention
  • QOL and Symptom Control
  • Biologic Correlative Science including tissue
    procurement
  • Phase I to III
  • Comparative Effectiveness?
  • Portfolio should meet the diverse needs of your
    service population

7
Exemplary 2 High Accrual
  • Demonstrate the highest accrual activity possible
    for the area demographics
  • Establish a site benchmark based on
  • Patient volume
  • Patient mix
  • Available studies
  • One annual US benchmark patients entered on
    trials / new patients
  • Screening outcome software (DDOTS)
  • Accrue gt 10

8
Exemplary 3 Clinical Trial Process Participation
  • Investigator and research support staff
    collaboration with academic centers and sponsors
  • Scientific and practical trial conduct input
  • Examples
  • Attend sponsor research meeting
  • Develop, conduct, and author a trial
  • Leadership roles locally and with sponsor
  • Volunteer member of sponsor boards and committees

9
Exemplary 4 Formal Maintenance of High Education
  • Specialty Board Certified if relevant
  • Research support staff qualified by education and
    training (CRA certification)
  • Investigator and research staff continuing
    education.
  • Society Clinical Research Associates
  • Association of Clinical Research Professionals
  • Human Rights Education for all

10
Exemplary 5 Quality Assurance
  • Routine self audits
  • Modification of existing SOPS and adoption of new
    SOPS
  • Principal Investigator interaction with IRB
  • Recording of minor and major violations
  • External audit high performance
  • Corrective action plans and implementation
  • Timely and complete data submission to sponsor

11
Exemplary 6 Multidisciplinary Involvement
  • Both specialty physicians and non-physicians
    desirable
  • Increased site expertise will increase scope and
    complexity of offered trials
  • Other MDs Radiation Oncology, Surgery,
    Pathology, Radiology, Primary Care
  • Others Pharmacists, Psychologists, Nursing, CRA

12
Exemplary 7 Clinical Trials Awareness
  • Increase awareness in physician and lay
    communities
  • Marketing programs
  • Educational programs
  • Patient advocacy groups
  • Develop a planned program
  • Review plan periodically and adjust

13
NCI Clinical Trials Assessment of Infrastructure
Matrix Tool (CT AIM)
  • National Cancer Institute U.S. DEPARTMENT OF
    HEALTH AND HUMAN SERVICES National Institutes of
    Health

ASCO Community Research Forum October 4, 2013
14
Potential Uses for CT AIM
15
Exemplary Attributes CT AIM Assesses
  • Physician Engagement in Clinical Trials
  • Clinical Trial Portfolio Diversity and Management
  • Participation in Clinical Trial Process
  • Clinical Trial Workload Assessment
  • Biospecimen Research Infrastructure
  • Accrual Activity
  • Education Standards
  • Quality Assurance
  • Multi-Disciplinary Team Involvement
  • Clinical Trial Education and Community Outreach
  • Clinical Research Team/Navigator Engagement

16
ASCO Tool
  • 1.5 years in development
  • 54-page comprehensive document
  • Sections include
  • Background and context
  • Major components
  • Descriptions/Definitions,
  • Examples/samples,
  • Suggested guidelines
  • How-tos,
  • References
  • Additional Resources and ASCO Exemplary
    Attributes Publication Series listings
  • 18 pages of sample tools/templates
  • ASCO Clinical Research Quality Assessment
    Checklist Tool
  • 4 main sections
  • 26 sub-sections

17
Major Components of the Tool
  • Internal Quality Assessment Process
  • Investigator and Staff Qualifications and
    Training Requirements
  • Research Integrity
  • HIPAA Authorization for Research
  • Conflict of Interest
  • Tracking to Ensure Research is Incorporated in
    Clinical Care
  • Data Collection, Management, and Quality Control
  • Standard Operating Procedures
  • Document Control and Other Considerations
  • Internal Quality Control for Trial Participants
  • Internal Quality Assurance Auditing for Research
    Programs

18
Orientation Checklist Sample
CLINICAL RESEARCH PROGRAM SPECIFIC CLINICAL RESEARCH PROGRAM SPECIFIC CLINICAL RESEARCH PROGRAM SPECIFIC CLINICAL RESEARCH PROGRAM SPECIFIC
  Trainer Initials Trainee Initials Date Reviewed
GENERAL GENERAL GENERAL GENERAL
Review of Importance of Clinical Trials (NCI)      
Review of Overview of Clinical Trials (NCI)      
Archive Policies      
RESEARCH PROTOCOLS RESEARCH PROTOCOLS RESEARCH PROTOCOLS RESEARCH PROTOCOLS
Clinical Trials listing/protocol menu      
Definitions of types of trials IIT, Cooperative Group, Industry      
Understanding a protocol      
RESEARCH MANAGEMENT RESEARCH MANAGEMENT RESEARCH MANAGEMENT RESEARCH MANAGEMENT
Tools, standard forms/memos      
Departmental paper filing system      
Departmental electronic filing system      
SUBJECT MANAGEMENT SUBJECT MANAGEMENT SUBJECT MANAGEMENT SUBJECT MANAGEMENT
Enrollment      
Response RECIST, WHO, other      
Toxicity grading CTCAE      
Pathologic Response      
REGULATORY REGULATORY REGULATORY REGULATORY
HIPAA      
Regulatory start-up      
Regulatory filing      
Excerpt
19
Prepared by Robin Zon, MD, FASCO, FACP
  • Special Thank You to
  • Eileen Drummond, NCI
  • Steve Grubbs, MD, Christiana CCOP
  • Suanna Bruinooge, ASCO
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