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IMPACT OF COVID-19 ON THE CONDUCT OF CLINICAL TRIALS FDA guidance (March 2020) Developed by: U-MIC University of Michigan IRB Collaborative

COVID-19 and clinical trials FDA COVID-19 guidance: March 2020 • • to assist sponsors/researchers in • • • ensuring the safety of study subjects maintaining good clinical practice minimizing risks to research integrity • • • quarantines site closures travel limitations supply chain interruptions other issues Disruptions may be caused by: Protocol modifications may be necessary. Certain protocol deviations may be unavoidable. Developed by: U-MIC 3

COVID-19 and clinical trials FDA recommendations for ongoing trials • Subject safety is paramount. • Necessary changes to study conduct may relate to • • subject recruitment use of investigational products in subjects already participating subject monitoring • Subjects must be informed of all changes that may affect them. • • continue or discontinue administration of investigational product withdraw subjects Sponsors, researchers, and IRBs, determine how best to protect subjects’ safety, welfare, and rights Developed by: U-MIC 4

COVID-19 and clinical trials FDA recommendations for ongoing trials • • If subjects are unable to visit study sites, evaluate feasibility/adequacy of alternative methods for safety assessment • • • phone contact virtual visit alternative locations • may require additional safety monitoring and measures Subjects who lose access to investigational product/means to visit study site • Developed by: U-MIC e. g. , discontinuation of active investigational treatment 5

COVID-19 and clinical trials FDA recommendations for ongoing trials • Necessity of process modification will vary by protocol and local situation, depending on • • • whether appropriate to delay some assessments in ongoing studies whether to stop recruitment or withdraw subjects, if research cannot be properly conducted under existing protocol Screening procedures mandated by health care system where clinical trial is conducted do not have to be reported as protocol amendments • • even if performed during study visits unless sponsor plans to use data for new research Developed by: U-MIC 6

COVID-19 and clinical trials FDA recommendations for ongoing trials • Sponsors and researchers anticipating urgent/emergent changes to protocol/consent materials • • engage with IRBs as early as possible No IRB approval or IND/IDE amendment necessary to implement changes to • • • minimize/eliminate immediate hazards protect the life/well-being of subjects • However, all such changes must be reported afterwards. • Document reasons for contingency measures. Alternative processes must be as consistent with protocol as possible. Developed by: U-MIC 7

COVID-19 and clinical trials FDA recommendations for ongoing trials • • Missing information may result from • • • study visit schedule changes missed visits subject discontinuations • to explain the basis of the missing data Capture specific information in case report form • Developed by: U-MIC including the missing information’s relationship to COVID-19 8

COVID-19 and clinical trials FDA recommendations for ongoing trials • When scheduled visits at study sites are significantly impacted • alternative secure delivery methods may be appropriate for certain investigational products • • e. g. , those typically distributed for self-administration For investigational products normally administered in health care setting • consult applicable FDA review divisions regarding alternative administration • • Developed by: U-MIC home nursing trained but non-study personnel at alternative sites 9

COVID-19 and clinical trials FDA recommendations for ongoing trials • • • Consult appropriate FDA review division regarding protocol modifications for efficacy endpoint collection • • • use of virtual assessments delays in assessments alternative collection of research-specific specimens • consider consulting with appropriate FDA review division • consider optimizing use of central/remote monitoring programs If protocol changes will lead to amending data management and/or statistical analysis plans If planned on-site monitoring visits are no longer possible Developed by: U-MIC 10

COVID-19 and clinical trials General recommendations • Sponsors, researchers, and IRBs should consider implementing policies/procedures, or revising those existing • • to describe approaches to protecting subjects and managing study conduct during any study disruption Changes might address impact on: • • informed consent study visits/procedures data collection study monitoring adverse event reporting study personnel/monitors Policy/procedures must comply with applicable policy for COVID-19 management/control. Depending on the nature of changes, a protocol amendment may be required. Developed by: U-MIC 11

COVID-19 and clinical trials General recommendations • Sponsors should include, either in the clinical study report or in a separate study-specific document: • • description of contingency measures implemented to manage study conduct during disruption list of subjects affected by the disruption • • by unique subject number identifier by investigational site description of how each subject’s participation was altered analyses/discussions on impact of contingency measures on safety and efficacy results Developed by: U-MIC 12

COVID-19 and clinical trials Impact of COVID-19 on the conduct of clinical trials FDA Guidance on Conduct of Clinical Trials of Medical Products During the COVID-19 Pandemic (March 2020) Developed by: U-MIC 13

THANK YOU. Brian Seabolt IRBMED Developed by: U-MIC 14