FDA EIR - Brian B. Siu, M.D., Ph.D. - August 22, 2019

An FDA inspection of Brian B. Siu, M.D., operating as a clinical investigator for Marvel Research, LLC, took place from August 13 to August 22, 2019. This initial inspection, conducted under the Bioresearch Monitoring Compliance Program 7348.811, focused on Good Clinical Practices (GCPs) for investigational human drug studies, falling under the regulatory framework of section 505 of the Food, Drug & Cosmetic (FD&C) Act. The inspection concluded with no significant objectionable findings, and no Form FDA 483 Inspectional Observations were issued.

However, discussions with management highlighted several areas for improvement. These included a noted lack of oversight for a service provider conducting specific study procedures like vital sign measurements and sleep assessments, with instances of non-adherence to protocol-required resting periods. Data integrity concerns were raised regarding inconsistent time documentation between study personnel and the service provider, and the absence of unique identifiers in audit trails for certain electronic data entries (e.g., quality of life questionnaires and eDiaries). Additionally, the report mentioned two missing personnel CVs as a potential observation.

While no formal corrective actions were mandated, Dr. Siu and his team were advised to enhance oversight of service providers through periodic monitoring and documented training, standardize time-keeping, and ensure all personnel CVs are on file. The sponsor had previously discontinued the site's participation in studies due to non-compliance, separate from the FDA's current findings.