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Sponsor Expectations for Clinical Studies

This article explores investigator responsibilities and sponsor assessments of investigator performance in clinical studies. It also highlights what Thomas Jefferson University does well and provides tips on how investigators can impress sponsors.

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Sponsor Expectations for Clinical Studies

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

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

  3. 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

  4. Investigator Responsibilities

  5. Investigator Responsibilities

  6. 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?

  7. 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

  8. 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

  9. 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.

  10. Questions?

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