FDA EIR - National Cancer Institute, Cancer Therapy Evaluation Program - July 17, 2014

The FDA inspected the National Cancer Institute, Cancer Therapy Evaluation Program (NCI, CTEP) from June 16 to July 17, 2014, in their capacity as a clinical trial sponsor for BLA No. 125516, involving protocol ANBL0032. The inspection, conducted under regulations governing clinical trial sponsors, identified multiple compliance issues. Primary violations included a failure to provide a comprehensive list of all investigators involved in the study and selecting unqualified or unregistered personnel, such as a physician who co-consented a patient without proper registration or an FDA-1572 form. The trial monitoring was deemed inadequate, with 22 of 163 sites not having patient cases reviewed, on-site audits occurring only every three to four years, and a limited scope of patient case review. Additionally, financial disclosure documents were not consistently collected from all investigators, and the program had delayed implementing financial disclosure requirements. Issues with electronic records included unvalidated data systems and randomization algorithms. NCI, CTEP submitted a written response, proposing a new centralized system to track investigators, but specific corrective actions for the ANBL0032 study findings were not detailed.