CSL Limited Annual Report 2021/22 34 Listening to our patients’ needs One of CSL’s most valuable assets is our ability to engage in meaningful dialogue with patients and their support networks. Understanding patient needs has contributed significantly to the success of CSL’s R&D operations. During 2021/22, more than 40 advisory boards were conducted with patients and members of their support community. Building on this experience, we are creating events and forums where patients sit alongside senior CSL executives to guide and shape our corporate patient focus mindset and strategies. Through our close working relationship with patients, CSL is better able to keep our promise to patients and the public’s health and enhance our overall reputation. ‘ We embed patient focus into our ways of working – learning the needs of patients and amplifying their voices in the development of therapies – helping us to Deliver on Our Promise.’ Deirdre BeVard, Senior Vice President, R&D Strategic Operations Clinical trials in progress and new In 2021/22, CSL had 58 clinical trials in operation across all therapeutic areas. Of those, 5 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. 58 clinical trials in operation across all therapeutic areas 3 regulatory authority inspections with no impact to clinical trial conduct The CSL Clinical Quality Management System allows us to monitor and effectively oversee the quality of our clinical trials and includes both regulatory authority inspections and internal audits for good clinical practice (GCP), good pharmacovigilance practice (GVP), good manufacturing practice (GMP), good laboratory practice (GLP) and good research laboratory practice (GRLP). Over the reporting period, three clinical trials were added, and 15 clinical trial results were posted, on an International Committee of Medical Journal Editors (ICMJE)-recognised public clinical trial registry. 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 ICMJE, WHO guidance and legislative requirements. In addition, three inspections were undertaken by regulatory agencies including the Japanese Pharmaceuticals and Medical Devices Agency (PMDA) and regional health authorities in Germany. All inspections confirmed adherence with GCP requirements, validated the data integrity of our clinical trials and had no impact on clinical trial operations. When Patients Speak – CSL Listens When CSL needed to assess how best to implement a series of upcoming studies, we didn’t make assumptions – we asked patients. By listening to patients from several countries around the world, we were able to gain valuable insights regarding the diagnosis journey, treatment paradigms, potential barriers to study participation, attitudes around clinical research within the patient population and other key factors crucial to study protocol design and clinical trial planning. Our Clinical Operations group has also pioneered embedding patients into our study teams to better ensure patient focus in our clinical trials. 6 Powered by Innovation
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