CSL Ltd Annual Report 2020

Clinical trials in process and new In 2019/20, CSL had 34 clinical trials in operation across all therapeutic areas. Of those, nine had a first patient enrolled in the trial during the year. CSL conducts ethical clinical trials and adheres to exemplary standards of integrity in the formulation, conduct and reporting of scientific research. This is based upon three primary elements: scientific integrity, patient safety and investigator objectivity. 34 clinical trials in operation across all therapeutic areas. 17 regulatory inspections with no impact to clinical licences. The CSL Clinical Quality Management System allows us to monitor and effectively oversee the quality of our clinical trials and includes all good clinical practice (GCP), pharmacovigilance (PV), good laboratory practice (GLP), and good research laboratory practice (GRLP) audits. Over the reporting period, 15 clinical trial registrations and seven clinical trial results were published and made readily available to stakeholders and the general public. These were all disclosed in a timely manner and in compliance with our transparency policy. Our policy reflects international requirements and standards including requirements from the International Committee of Medical Journal Editors , WHO guidance and legislative requirements. In addition, 17 (11 CSL Behring and six for Seqirus) inspections were undertaken by regulatory agencies such as the US FDA, the Pharmaceuticals and Medical Devices Agency of Japan (PMDA) and the Paul Ehrlich Institute (PEI). All inspections confirmed adherence with GCP requirements, validated the data integrity of our clinical trials and had no impact on clinical trial licences or operations. Power of real-world evidence The use of Real-World Evidence (RWE) is gaining importance amongst policy makers, decision makers and purchasers. Seqirus established an innovative and cutting-edge dataset to conduct Real-World Research (Observational/Phase IV studies). This dataset links one of the largest electronic medical health record datasets in the US with a large pharmacy and medical claims dataset incorporating more than 45 million unique individuals. This unique real-world anonymised data provides a comprehensive perspective on the health status, service utilisation and financial profile of both individuals and population. Seqirus Medical Affairs uses this dataset to generate real-world evidence critical in evaluating influenza vaccine effectiveness for continued advances in influenza prevention. CSL Limited Annual Report 2020 30 Powered by Innovation 7