Clinical Trials

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 governance

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.

  • Policies and procedures are a key component of our Clinical Quality Management System and are aligned with GCP of the International Conference of Harmonization and industry-best practices. Our policies and procedures support effective decision making, provide our employees and vendors clear guidelines on what they can and cannot do, what decisions they can make and what activities are appropriate.
  • Governance committees are in place for scientific review of clinical programs, data safety monitoring, quality management, vendor selection and performance and overall operational performance. These committees have defined charters and are made up of well-trained experts from various disciplines.
  • Health care professionals (HCP) fair market value guide and contractual controls for both investigative sites and vendors enable HCPs to be compensated according to contractual arrangements with their institutions and in alignment with fair market value.
  • Active monitoring of clinical trials via ongoing electronic data review allows regular assessments of trends in patient data and monitoring of safety parameters.
  • On-site monitoring across all of our global study sites ensures protocol adherence and compliance.

Number of pre-clinical and clinical studies commenced1 in 15-16

R&D strategy area Preclinical2 Phase I Phase II Phase III Phase IV Total number of clinical trials commenced
in 15-16
Total number of clinical trials in operation
in 15-16
Haemophilia products 4 0 0 1 0 1 8
Specialty products 1 0 0 1 0 1 8
Immunoglobulins 0 1 0 1 1 3 6
Breakthrough medicines 0 0 1 0 0 1 3
Vaccines 0 0 0 2 4 6 23
TOTALS 5 1 1 5 5 12 48

1 Defined as having a final protocol approved and study start-up activities commenced.

2 Total number of GLP-toxicological studies only.

More on our website

Visit our website for more information on CSL's approach to clinical trials and clinical trial disclosure and transparency.