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NCI’s Role as Sponsor of ACRIN Clinical Trials: Regulatory Considerations

American College of Radiology Imaging Network Fall Meeting. NCI’s Role as Sponsor of ACRIN Clinical Trials: Regulatory Considerations. Barbara A. Galen, MSN, CRNP, CNMT Cancer Imaging Program, National Cancer Institute, U.S.A. October 2-5, 2008 Pentagon City, Arlington, Virginia. Outline.

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NCI’s Role as Sponsor of ACRIN Clinical Trials: Regulatory Considerations

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  1. American College of Radiology Imaging Network Fall Meeting NCI’s Role as Sponsor of ACRIN Clinical Trials: Regulatory Considerations Barbara A. Galen, MSN, CRNP, CNMT Cancer Imaging Program, National Cancer Institute, U.S.A. October 2-5, 2008 Pentagon City, Arlington, Virginia

  2. Outline • NCI’s Relationship to ACRIN- sponsor and grantee • Basis for regulation and oversight • Key U.S. regulatory groups and regulations • Cornerstones of government oversight • Dr. Anna Edouard: Current AE reporting process • Ms. Shanda Finnigan: New AdEERS imaging pathway for electronic AE reporting

  3. Division of Cancer Treatment and Diagnosis Office of the Director, DCTD Biometric Research Branch Cancer Therapy Evaluation Program Cancer Imaging Program Radiation Research Program Cancer Diagnosis Program Developmental Therapeutics Program

  4. Sponsor and Grantee: Cooperative Agreement- linked U01’s • Partnership • Stewardship • Advice • Technical assistance • Coordination • Programmatic/scientific functions • Oversight of quality assurance and monitoring

  5. Basis for regulation/oversight • To protect and ensure patient safety and data accuracy & validity • Principles of bioethics (The Belmont Report) • Beneficence • Duty to protect the welfare of participants • Risk/benefits to individuals and communities • Study design? Valid Findings? If not, NO BENEFIT • Respect for persons • Duty to respect autonomous persons, their choices, and their information • Informed consent/Privacy of persons and confidentiality of information/Voluntary • HIPAA • Justice • Duty to distribute benefits and burdens fairly • Fair selection of individual/populations/ opposite is exploitation

  6. U.S. Regulations • 1991: adopted by 17 US federal agencies as “Common Rule” • CFR Title 45 Part 46 Protection of Human Subjects Revised June 23, 2005 • 21 CFR 50 and 56 • Health Insurance Portability and Accountability Act 1996 (HIPAA) • Office for Human Research Protections (OHRP) • Food and Drug Administration (FDA) • Centers for Medicare and Medicaid Services (CMS) • Office of Civil Rights (OCR)

  7. Government Oversight The Common Rule (Title 45 CFR Part 46, Subpart A) • Governed by Office for Human Research Protections (OHRP) – 17 Fed Dept /Agencies • Enforced by Office of Civil Rights (OCR) Sets standards for • Informed Consent Process • Formation and function of Institutional Review Board’s • Involvement of prisoners, children, and other vulnerable groups NIH and OHRP together: strengthened in 2000 • Education and Training in human subjects protection • Data and safety monitoring plans-all /boards for Phase III trials • Audit informed consent process • Clarify regulations regarding conflict of interest

  8. Government Oversight • Title 21 CFR Parts 50 and 56 • Enforced by the Food and Drug Administration (FDA) • IRB review • Informed consent • Participant protection Apply to any clinical trial that involves • Investigational drug or imaging agent • Biological product, or • Device regulated by FDA- regardless of Federal Funding Periodically inspects IRB records and operations

  9. Protecting Participants • Protection of Participants before the Trial Begins • Scientific Review by the Sponsor • Significance, Approach, Innovation, Investigator, Environment • Institutional Review Board (IRB) Approval • Informed Consent Document/Process • Legal, regulatory, ethical concept

  10. Protecting Participants • Protecting Participants During a Clinical Trial • Informed Consent Process • IRB- approval/monitor progress • DSMB-monitoring/oversight • Quality Assurance Monitoring • Data quality/integrity • Auditing • Adverse Event Reporting

  11. Resources on the Web • Cancer Imaging Program (CIP) http://imaging.cancer.gov • The NCI Clinical Trials http://www.cancer.gov/clinicaltrials • Human Subject Protections Education-web-based http://cme.cancer.gov/clinicaltrials/learning/humanparticipant-protections.asp • CFR Title 45 Part 46 Protection of Human Subjects Revised June 23, 2005 http://www.access.gpo.gov/nara/cfr/waisidx_01/45cfr46_01.html • 21 CFR 50 and 56 http://www.access.gpo.gov/nara/cfrwaisidx_01/21cfr50_01.html Also see sections 12.1.1 and 12.1.2 Agencies FDA http://www.fda.gov/ CMS http://www.cms.hhs.gov/ OHRP http://www.hhs.gov/ohrp/ OCR http://www.hhs.gov/ocr/hipaa

  12. NCI Contacts • Ms. Irenna Zubal 301-496-9531 zubalire@mail.nih.gov • Ms. Barbara Galen 301- 496-9531 bgalen@mail.nih.gov • Dr. Lalitha Shankar 301- 496-9531 shankarl@mail.nih.gov

  13. American College of Radiology Imaging NetworkFall Meeting Current SAE Reporting Process: Cancer Imaging Program Non-IND Studies Dr. Anna Edouard Senior Safety and Pharmacovigilance Specialist, Contractor Technical Resources International, Inc October 2, 2008

  14. CIP SAE Reporting Clinical Site Requests Information (source documents) Submits SAE report TRI Notifies (SAE receipt, info request) Triages packet(SAE report, source documents) ACRIN Assesses SAE report CIP

  15. CIP SAE Reporting • Clinical site fills out appropriate sections of the SAE submission form • Note: For a 24-hour phone notification, follows up with a faxed SAE submission within 5 business days. • Faxes SAE submission form with any additional information (supporting source documents) to (301) 897-7402, attention CIP SAE Team.

  16. CIP SAE Reporting • Clinical site follows up with an email to CIPSAEReporting@tech-res.com notifying team that an SAE form has been faxed.

  17. CIP SAE Reporting • TRI retrieves the faxed documents (SAE report), notifies ACRIN and the CIP staff/ Medical Monitor (MM) of receipt, and triages the packet. • TRI requests from the site any pertinent medical information necessary to evaluate the report. • Sends SAE report, supporting documents, and newly-created tracking record to CIP staff via email for assessment.

  18. CIP SAE Reporting • CIP staff reviews SAE report, signs Part A of tracking record electronically, and sends back to TRI who logs in the information and status of the report. • CIP may request that TRI send a follow-up query to the site for additional information. ACRIN and CIP are copied on any emails sent to site requesting additional information.

  19. CIP SAE Reporting • Once TRI is satisfied that all pertinent information has been received, the SAE report, tracking record, and supporting documents are forwarded via email to the MM for assessment. MM completes Part C of the tracking record and signs electronically. MM emails this tracking record back to TRI.

  20. CIP SAE Reporting • Upon receipt of tracking record via email, TRI completes Part D and files the completed report electronically. The original hardcopy is sent to CIP for filing.

  21. Lessons Learned • Follow-up email from clinical site to TRI after submission of paper document is inconsistent. • Situations in which there are 2 or more SAEs being reported require a separate report to be completed for each event. • Attributions for each SAE must be indicated on submitted reports (select 1-5 to indicate unrelated, unlikely, possible, probable, definite).

  22. Contact Information • Anna Edouard, MD Tel.: 301-897-7447 Fax: 301-897-7402 Email: aedouard@tech-res.com • James Murray, PhD (CTEP AE Team Manager) Tel.: 301-897-1717 Fax: 301-897-7402 Email: jmurray@tech-res.com

  23. Contact Information • AdEERS Helpdesk (AdEERSMD): Tel.: 301-897-7497 Email: adeersmd@tech-res.com • CIP SAE Reporting Desk Fax: 301-897-7402 Email: CIPSAEReporting@tech-res.com • Adverse Event Expedited Reporting System (AdEERS) http://ctep.info.nih.gov Find clinical trial resources on right-hand side and click on AdEERS.

  24. American College of Radiology Imaging NetworkFall Meeting AdEERS: New electronic imaging pathway CIP/CTEP/CTIS Shanda Finnigan, RN, BSN, CCRC Health Program Specialist Contractor CTEP, DCTD, NCI October 2, 2008

  25. CTEP’s Adverse Event page: http://ctep.cancer.gov/reporting/adeers.html

  26. AdEERS Application: https://webapps.ctep.nci.nih.gov/openapps/plsql/gadeers_main$.startup

  27. Contact Information • Medical Questions/Help • email: adeersmd@tech-res.com • phone: (301) 897-7497 • fax: (301) 230-0159 • Technical Questions/Help • email: ncictephelp@ctep.nci.nih.gov • phone: 1-888-283-7457 • fax: (301) 948-2242 • Shanda Finnigan, RN, BSN, CCRC • email:finnigas@mail.nih.gov

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