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

Prepared by Robin Zon, MD, FASCO, FACP

Special Thank You to Eileen Drummond, NCISteve Grubbs, MD, Christiana

CCOPSuanna Bruinooge, ASCO