fourth annual medical research summit concurrent session 4.05 – managing cros and smos from a...
TRANSCRIPT
![Page 1: Fourth Annual Medical Research Summit Concurrent Session 4.05 – Managing CROs and SMOs from a Compliance Perspective Michael SwiatochaAprill 23, 2004](https://reader035.vdocuments.net/reader035/viewer/2022062518/56649e605503460f94b5a720/html5/thumbnails/1.jpg)
Fourth Annual Medical Research Summit
Concurrent Session 4.05 – Managing CROs and SMOs from a Compliance Perspective
Michael Swiatocha Aprill 23, 2004
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Agenda for Concurrent Session
Introductions
Industry Background
An Approach to Managing CROs and SMOs
FDA Inspections
Fraud and Abuse in Clinical Trials
Questions & Answers
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Industry Background
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Industry Background
Complex Scenario
Intensive regulatory process
Demand for higher quality clinical data
Competition for clinical investigators
Shortage of human subjects
Global clinical research programs
Co-development partnerships
Reliance on outsourcing to service providers (e.g., CROs and SMOs)
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Industry Background
Outsourcing is not a new concept
Estimated that 42% of all pharmaceutical drug development expenditures in 2004 will be committed to outsourcing
Skyrocketing growth of the CRO market
– 1992 – approximately $1 billion
– 2002 - > $8 billion
– 1992 – 7 million subjects
– 2001 – 20 million subjects
Rapidly evolving business of SMOs for managing multi-site clinical trials
CROs and SMOs – competitors, partners or both?
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Industry Background
Basic premise for this presentation under 21 CFR 312.52 Transfer of obligations to a contract research organization.
Sponsor CRO
Sponsor SMO
Sponsor CRO SMO
CROs = SMOs
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Industry Background
FDA Compliance Program 7348.810 - Sponsors, Contractors, and Monitors of Clinical Investigations
Responsibilities of sponsors:
– Obtain agency approval for clinical studies
– Manufacture and label investigational drug
– Initiate, withhold, discontinue clinical trials
– Select qualified investigators and monitors
– Evaluate and report adverse experiences
– Maintain records
– Submit progress reports and the final results of studies
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Industry Background
FDA Compliance Program 7348.810 - Sponsors, Contractors, and Monitors of Clinical Investigations
Sponsors may transfer responsibilities to a Contract Research Organization (CRO):
– Written agreement specifying transferred responsibilities
– CROs are subject to same regulatory actions as sponsor
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Approach to Managing CROs and SMOs
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Approach to Managing CROs and SMOs
Consider compliance-related implications when selecting, managing, evaluating, retaining and dismissing CROs and SMO
Proposal – Follow the OIG Compliance Program Guidance for Pharmaceutical Manufacturers published in April 2003
Rationale:
– Seven elements of an effective compliance program
– Based on U.S. Sentencing Commission’s organizational sentencing guidelines
– Communicated in OIG CPG and Corporate Integrity Agreements
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Approach to Managing CROs and SMOs
Seven elements of an effective corporate compliance program
– Standards and Procedures
– Oversight Responsibility
– Education and Training
– Lines of communication
– Monitoring and auditing
– Enforcement and Discipline
– Response and Prevention
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Approach to Managing CROs and SMOs
Seven elements of compliance programs applied to CROs and SMOs
Standards and Procedures – Has the organization established written standards and procedures for the regulatory obligations assumed under 21 CFR 312.52? What about KPIs?
Oversight Responsibility – Have individuals with the appropriate experience been assigned responsibility to oversee compliance with established standards?
– Prior experience in Phase I through IV studies including numbers of studies, subjects, sites, etc.
– Professional qualifications for monitors, project managers and CRAs
– Average years of employment of monitors by the organization
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Approach to Managing CROs and SMOs Seven elements of compliance programs applied to CROs and SMOs
(continued)
Education and Training – Does the organization conduct training programs and document employee participation?
– Orientation training for new hires
– Ongoing training for experienced personnel
Lines of Communication – Does the organization take steps to communicate its standards to employees and sponsors?
– KPIs for trip reports, completion of CRFs, QA audits and findings
– Hotline for reporting suspected violations
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Approach to Managing CROs and SMOs Seven elements of compliance programs applied to CROs and SMOs
(continued)
Monitoring and Auditing – Does the organization take reasonable steps to achieve compliance with its standards by routinely using monitoring systems?
– % of clinical sites audited by QA; qualifications of auditors
– Process for reporting audit findings and corrective action to the sponsor
– Results of FDA audits
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Approach to Managing CROs and SMOs Seven elements of compliance programs applied to CROs and SMOs
(continued)
Enforcement and Discipline – Standards should be enforced consistently through appropriate disciplinary mechanisms.
– Describe a situation where the organization had to remove a CRA from a study for performance issues.
– What is the procedure for replacing study personnel?
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Approach to Managing CROs and SMOs Seven elements of compliance programs applied to CROs and SMOs
(continued)
Response and Prevention – Does the organization have a process for investigating suspected violations of standards, taking reasonable steps to respond appropriately, and to prevent further similar offenses?
– Assigned responsibility for conducting investigations
– Procedure for documenting findings
– Review/approval of corrective and preventive action plans
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FDA Inspections at CROs and SMOs
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FDA Inspections
Suggestions to enhance readiness for inspection by regulatory agencies:
Assign responsibility for managing an inspection to key individuals and identified designees
Assign responsibilities for inspection tasks to individuals and designees (note-taking, retrieving documents, accompanying inspectors, etc.)
Address logistics (meeting room, equipment, contact list, etc.)
Review results of past sponsor and CRO audits
Prepare and train through mock inspections
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Fraud and Abuse in Clinical Trials
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Fraud and Abuse in Clinical Trials
Fundamental concerns about the pharmaceutical marketplace
Is money – or anything of value – interfering with independent clinical/formulary decisions?
Is misleading, inaccurate, or other inappropriate information influencing independent clinical/formulary decisions?
Are inappropriate marketing practices leading to increased federal/state/private expenditures?
Are these or any other practices placing patient safety and interests at risk?
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Questions & Answers
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For More InformationMichael P. Swiatocha
Vice President and SPRI Compliance Officer
Schering-Plough Corporation
908-740-5260