A clinical trial is a research study in which people volunteer to receive a medical treatment and to be observed for its effects, both in terms of its safety and its effectiveness. Before a clinical trial can begin, the experimental product is first tested extensively in the laboratory and where necessary, in animals. Clinical trials are carefully supervised, monitored, and documented. The applicable regulatory authority must grant approval to conduct testing in humans, and clinical trials are overseen by an independent review or ethics committee.
CSL conducts clinical trials in accordance with the current Guideline for Good Clinical Practice (GCP) of the International Conference on Harmonisation (ICH). GCP is an international ethical and scientific quality standard for designing, conducting and reporting studies that involve the participation of human subjects. Compliance with this standard provides public assurance that the rights, safety and well-being of study subjects are protected and that the clinical trial data are credible. It also ensures that CSL conducts clinical trials consistent with the principles specified in the Declaration of Helsinki (a set of ethical principles regarding human experimentation developed by the World Medical Association and originally adopted in 1964).
CSL’s Quality Management System consists of an independent Quality Assurance function along with a Quality Operations group that is a part of the Clinical development organisation. Together, the two groups provide the foundation for a risk-based, proactively managed Quality System across Global Clinical development that ensures regulated clinical trial activities are:
- Conducted with a high level of quality;
- Conducted according to regulatory requirements;
- Consistent with industry best practices;
These objectives are achieved through:
- Maintenance of a robust set of written standard operating procedures (SOPs) with staff adequately trained against them;
- A compliance monitoring program to ensure adherence to the SOPs and drive inspection readiness;
- A well-defined Corrective Action/Preventive Action (CAPA) management process that promotes a systematic approach to dealing with critical/major issues and enabling study teams to effectively apply real-time lessons learned;
- Execution of audits on our investigative sites, vendors, and internal processes/systems.
Participation in clinical trials is voluntary, and people cannot take part in a clinical trial without their knowledge and consent.
CSL conducts clinical research under strict procedures of informed consent. Informed consent is a process of information exchange that involves providing a subject with the key information about a study, and ensuring that the subject understands what the study is about. This information exchange occurs before a subject decides to enrol in a study, and the exchange continues for the duration of the study should the subject decide to take part. Information about the study is provided in language that is easy to understand and includes the aim of the study, what will happen during the study, what the researchers are hoping to accomplish, the treatments being tested and how they are thought to work, and any potential risks and benefits to the subject.
Informed consent protects participants from unauthorised research, and protects participants’ rights and privacy. Participants can withdraw from a CSL clinical trial at any time. CSL performs rigorous monitoring at investigative sites for all clinical trials to ensure every single participant has freely given documented informed consent prior to participation. Furthermore, CSL informed consent procedures ensure updates (when there are changes to the study/ new information on risks) to the form are applied in a timely manner and communicated to the participant as soon as possible in order that they can make an educated decision to continue on in the clinical trial.
Clinical trial transparency
CSL is committed to ensuring the transparency and public accessibility of information related to our global clinical research activities. We register our CSL-sponsored clinical trials on a public registry before trial initiation to help patients, their healthcare providers and caregivers identify clinical trials that might be appropriate for them. Observational and/or non-interventional trials are also registered as required by applicable regulations. We disclose the results of these trials in a timely fashion according to regulatory and legal requirements, regardless of outcome, on a publicly available results database to ensure that patients, healthcare providers, caregivers and patient advocacy groups have ready access to trial results. The primary trial registry and results database used by CSL is ClinicalTrials.gov, which is administered by the United States National Library of Medicine. CSL may also register clinical trials and disclose results on other trial registries and databases, in compliance with local applicable regulatory and legal requirements. In general, we also seek to publish the results of our sponsored clinical trials in peer-reviewed journals.
CSL follows a documented process for trial registration and results disclosure, which reflects the CSL company policy on disclosure. We keep up to date with the latest in global trial disclosure requirements, for example, by attending trial disclosure conferences and participating in global trial disclosure organisations and working groups. The trial details and results to be made public are taken from official trial documents including the final trial protocol and the trial’s results report. The trial details and results intended for publication are reviewed and approved cross-functionally and undergo a final quality check to ensure the information is correct and meets the applicable requirements for disclosure. The trial information is then submitted to the relevant trial registry, such as ClinicalTrials.gov
The use of animals in research
Like all pharmaceutical companies, we are required by law to conduct animal research before testing new medicines in people, and to assure efficacy and quality of therapies in production. In this way animals play a vital role in saving lives and advancing human health.
We are committed to maintaining the highest standards of welfare for all animals involved in our research. Any laboratory test that involves the use of animals is licensed and closely regulated under local laws and international codes of practice.
Our Animal Ethics Committees (AECs) ensure that all applicable laws and standards are rigorously applied at CSL. Our AECs must review every CSL research proposal that involves animals and determine whether the use of animals is justified. They are also responsible for ensuring alternatives to animals have been considered and that the minimum number of animals is used. We will not commence any research involving animals unless an AEC has approved the scientific procedures, premises and technical qualifications of those involved in the research.
CSL and stem cell research
CSL does not use stem cells in its current research program. However we recognise that protein-based approaches are unlikely to address all serious diseases and that stem cell-based therapies may represent an effective and viable alternative in the future. For this reason CSL constantly monitors developments in this area.