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 (> 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 (> 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 > 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 MD’s: 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. National Cancer Institute U.S. DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health NCI Clinical Trials Assessment of Infrastructure Matrix Tool (CT AIM) ASCO Community Research Forum October 4, 2013

14. Potential Uses for CT AIM Program self- assessment, development, and improvement Benchmarking program performance and infrastructure Program or progress reporting for funders or sponsors Planning and communicating with senior leaders about program needs

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-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

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 Trainer Initials Trainee Initials Date Reviewed GENERAL Review of Importance of Clinical Trials (NCI) Review of Overview of Clinical Trials (NCI) Archive Policies RESEARCH PROTOCOLS Clinical 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 MANAGEMENT Enrollment Response: RECIST, WHO, other Toxicity grading: CTCAE Pathologic Response 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