Sponsor Expectations for Clinical Studies

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Presentation transcript:

Sponsor Expectations for Clinical Studies Stephen Workman, MPH September 2016 Thomas Jefferson University

Objectives Investigator responsibilities Sponsor assessment of PI performance What TJU does well How PIs can be more impressive to sponsors

Investigator Responsibilities Governed by: Code of Federal Regulations, Title 21 Part 11—Electronic records & signatures Part 50—Protection of human subjects Part 54—Financial disclosure Part 312—IND ICH guidelines for good clinical practice

Investigator Responsibilities

Investigator Responsibilities

Sponsor assessment of performance Evidence of PI involvement Conversant regarding progress of study Exhibits familiarity with subjects’ status, condition, compliance Awareness of severity, causality, resolution of AEs/SAEs Progress notes, lab reports signed within reasonable timeframe Assessing PI involvement Conversation—are stories consistent? Is communication candid or guarded? Can PI discuss key information (e.g., SAEs) without prompting by SC or other staff?

Result = Rapid start-up What TJU does well Streamlined processes Flexible IRB Frequent meetings (3 panels; 5 meetings per month) Can accommodate sponsor-mandated text Has process to resolve issues after two non-approvals Ability to outsource to contract IRB Result = Rapid start-up

How PIs can be more impressive Enrollment is a key measurement of investigator performance Inability to meet enrollment expectations is a principal reason that a sponsor will not consider an investigator or an institution for subsequent studies

How PIs can be more impressive Provide a conservative estimate of subjects who can reasonably be expected to qualify and consent to participate; work as hard as possible to meet or exceed your objective.

Questions?