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FDA s Clinical Investigator Course

The Clinical Investigator's Role in Drug Development. FDA Clinical Investigator Training CourseThe Clinical Trials Transformation Initiative Steering CommitteeNovember 8, 2010. Speakers / Panel. Adam Chasse QuintilesYvonne McCracken, MPH, CCRCCarolinas Research AssociatesCraig WozniakGl

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FDA s Clinical Investigator Course

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    1. Cosponsored by FDA’s Office of Critical Path Programs (OCPP) and The Clinical Trials Transformation Initiative (CTTI) FDA’s Clinical Investigator Course

    2. The Clinical Investigator’s Role in Drug Development FDA Clinical Investigator Training Course The Clinical Trials Transformation Initiative Steering Committee November 8, 2010

    3. Speakers / Panel Adam Chasse Quintiles Yvonne McCracken, MPH, CCRC Carolinas Research Associates Craig Wozniak GlaxoSmithKline

    4. Agenda Opening Remarks Commitment to Research Selecting Trial Sites Successful Site Performance Site Quality System Site Monitoring Question and Answer

    5. - Commitment to Research - Selecting Trial Sites Adam R. Chasse Head, Global Prime Sites Quintiles

    6. “Commitment” – two dimensions Philosophical (macro level) Protect trial patients’ safety and well-being Ensure data integrity Impact is on present and future patients worldwide Professional (micro level) Get viable and stay viable as a PI Grasp and overcome business complexities Impact is on sustainability of clinical development… and in turn, on patients

    7. Site Selection – What Does Industry Need? High quality PI involvement and accountability Right patients, right processes Consistent, proven ability to enroll Pick the right studies Plan for and manage delivery Efficient administrative processes Budget & contract IRB & regulatory documents

    8. Site Perspective on the Clinical Investigator’s Role in Drug Development Yvonne McCracken, MPH, CCRC Carolinas Research Associates

    9. Recruitment and Retention Have you determined if there are major challenges to recruitment & retention? Do you have the population within your practice? Do you know where to advertise for the population you are seeking? Does the study require specific retention strategies? Successful Site Performance

    10. Budget Do you know your true costs? Staff, printing, mailing, coping, dedicated phone & fax lines Space for CRC, monitor, study drug, supplies Advertising/recruitment activities Long term storage Computers and software required Payment terms Successful Site Performance

    11. Time Study start up – Protocol review, regulatory documents, contract/budget negotiation Training – GCP and Study specific Chart reviews and phone screens Study visits – In/Ex criteria, lab reviews, AE/SAE, IND safety reports CRF & Query completion Monitor visits Successful Site Performance

    12. Site Quality System Site Monitoring Craig Wozniak GlaxoSmithKline

    13. Site Quality System Framework that extends across investigator accountabilities Subject protection, data quality / integrity Collective efforts that enable investigators and staff to safely execute studies in a compliant manner

    14. Quality System

    15. Site Monitoring Why: Proactively identify and address issues different techniques used Establish expectations and discuss concerns Engage and allocate the time Aligned Partnership

    16. Question and Answer

    17. Adam Chasse Quintiles Adam.chasse@quintiles.com Yvonne McCracken, MPH, CCRC Carolinas Research Associates ymccracken@carolinasresearch.com Craig Wozniak GlaxoSmithKline craig.a.wozniak@gsk.com Questions

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