CSL continues to invest in clinical development activities as part of our R&D strategy. In 2015/16, CSL commenced 12 new trials, bringing the total number of clinical trials in operation across all therapeutic areas to 48.
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. The CSL Clinical Quality Management System allows us to monitor and effectively oversee the quality of our clinical trials. In 2015/16, we conducted 168 internal audits (128 CSL Behring; 40 Seqirus) of our clinical trial activities, which include study site, vendor, Good Clinical Practice (GCP)/Good Laboratory Practice (GLP), Pharmacovigilance, and document and system audits. In addition, 35 inspections (22 CSL Behring and 13 Seqirus) were undertaken by regulatory agencies (FDA, EMA and PMDA) to assess CSL's compliance with International Conference on Harmonization GCP guidelines, including inspecting the clinical trials associated with the recent approvals of AFSTYLA and IDELVION. 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.
Clinical trial design, conduct, performance, analyses and reporting are all governed by multiple mechanisms that allow CSL to ensure clinical trials follow ethical and scientific quality standards and protect patient rights, safety and confidentiality. The following are examples of governance mechanisms used to manage our clinical trials.
|R&D strategy area||Preclinical2||Phase I||Phase II||Phase III||Phase IV||Total
1 Defined as having a final protocol approved and study start-up activities commenced.
2 Total number of GLP-toxicological studies only.
Visit our website for more information on CSL's approach to clinical trials and clinical trial disclosure and transparency.