minimum standards and exemplary attributes of clinical trial sites s. gail eckhardt, md (slides...
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Minimum Standards and Exemplary Attributes of
Clinical Trial Sites
S. Gail Eckhardt, MD(Slides prepared by Robin Zon,
MD)
2008 JCO Special ArticleASCO Research Committee
•Minimal Standards•Exemplary Standards:•Clinical Trial Portfolio
Diversification•High Accrual (> 10%)•Participation in Clinical Trial Process•Formal Maintenance
of High Education Standards
•Quality Assurance•Multidisciplinary Care•Clinical Trials Awareness
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
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
Seven ASCO Exemplary Clinical Trials Site Attributes
1. Clinical Trial Portfolio Diversification2. High Accrual (> 10%)3. Participation in Clinical Trial Process4. Formal Maintenance of High Education Standards5. Quality Assurance6. Multidisciplinary Care7. Clinical Trials Awareness
• (Zon R, et.al., JCO 5/20/08)
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
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 > 10%
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
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
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
Exemplary 6: Multidisciplinary
Involvement• Both specialty physicians and non-
physicians desirable• Increased site expertise will increase
scope and complexity of offered trials• Other MD’s: Radiation Oncology, Surgery,
Pathology, Radiology, Primary Care• Others: Pharmacists, Psychologists,
Nursing, CRA
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
National Cancer InstituteU.S. DEPARTMENT OF HEALTH AND HUMAN SERVICESNational Institutes of HealthNCI Clinical Trials
Assessment of Infrastructure Matrix Tool (CT AIM)
ASCO Community Research Forum
October 4, 2013
Potential Uses for CT AIM
Program self-
assessment, development
, and improvemen
t
Program self-
assessment, development
, and improvemen
t
Benchmarking program
performance and
infrastructure
Benchmarking program
performance and
infrastructure
Program or progress
reporting for funders or sponsors
Program or progress
reporting for funders or sponsors
Planning and
communicating with senior leaders about
program needs
Planning and
communicating with senior leaders about
program needs
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
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-to’s,
– 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
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
Orientation Checklist SampleCLINICAL RESEARCH PROGRAM SPECIFIC
Trainer Initials
TraineeInitials
Date Reviewed
GENERALReview of Importance of Clinical Trials (NCI) Review of Overview of Clinical Trials (NCI) Archive Policies
RESEARCH PROTOCOLSClinical Trials listing/protocol menu Definitions of types of trials: IIT, Cooperative Group, Industry
Understanding a protocol RESEARCH MANAGEMENT
Tools, standard forms/memos Departmental paper filing system Departmental electronic filing system
SUBJECT MANAGEMENTEnrollment Response: RECIST, WHO, other Toxicity grading: CTCAE Pathologic Response
REGULATORYHIPAA Regulatory start-up Regulatory filing
Excerpt
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