CSL Limited Annual Report 2022/23 39 Listening to our patients’ needs The ability to collaborate with patients and their support networks remains an essential part of CSL’s efforts to make a meaningful difference to the lives of patients and to public health. We have continued to exemplify our dedication to understanding patients’ needs by expanding internal and external partnerships and engaging with industry partners who share similar values regarding patient focus. Through these important partnerships, CSL is navigating critically important areas which have a direct impact on areas such as patient diversity and inclusion in drug development, health equity and leveraging enabling technologies to improve how we interact with patients across R&D. CSL is inviting patients to directly comment on how it is discovering and developing the next wave of important therapies. These strategic efforts have resulted in numerous insights, improvements and efficiencies in CSL’s development programs and how the R&D pipeline is delivered. Through actively listening to patients’ needs, CSL makes a meaningful impact on patient lives and public health. We partner with industry leaders who share our patientfocused values, addressing diversity, health equity and leveraging technology to enhance R&D. Together, we drive improvements for a better future in drug development, helping us to deliver on our promise. Deirdre BeVard, Senior Vice President, R&D Strategic Operations Clinical trials in progress and new In 2022/23, CSL had 60 clinical trials in operation across all therapeutic areas. Of those, 12 had a first patient enrolled in the trial during the year. CSL conducts clinical trials ethically and adheres to the highest 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. 60 clinical trials in operation across all therapeutic areas 10 regulatory authority inspections with no impact to clinical trial conduct The CSL Clinical Quality Management System allows CSL to monitor and effectively oversee the quality of 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, 16 clinical trials were added, and 11 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 CSL’s transparency policy. This policy reflects international requirements and standards including requirements from ICMJE, WHO guidance and legislative requirements. In addition, 10 inspections were undertaken by regulatory agencies including the US Food and Drug Administration (FDA) and the Japanese Pharmaceuticals and Medical Devices Agency (PMDA). All inspections confirmed adherence with GCP requirements, validated the data integrity of our clinical trials and had no impact on clinical trial operations. CSL continues to improve clinical trial performance and reduce patient burden of participation, and we listened to patients to make it happen. Over the last 12 months, through direct patient feedback, we made multiple protocol modifications during the design stage for several high priority clinical trials. Addressing these protocol design challenges early resulted in a reduction in the number of protocol amendments during the conduct of the clinical trials. Patient insights also helped drive innovation within R&D by enabling us to identify several new capabilities which were incorporated into our clinical trials. Overall, listening to our patient advisory boards resulted in changes which helped reduce the patient burden in CSL clinical trials; making it more feasible for patients to participate in these studies and thus helping to advance our newer therapies towards those patients in need. When patients speak, CSL listens
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