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Bioethical Issues

Clinical Trials

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.

Governance of clinical trials

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.

Clinical trial transparency

CSL recognises that there are important public health benefits associated with making clinical trial information widely available to practising physicians, patients and patient associations. CSL supports policies and actions that seek to appropriately enhance the exchange of scientific information, and is committed to ensuring the transparency and public accessibility of information related to our global clinical research activities. This information better places people to make informed decisions about potential options for treatments as well as potential participation in clinical trials. CSL makes every effort to comply with national and international standards relevant to clinical trial disclosure and data.

To this end, CSL is committed to:

  • The prospective registration on a publicly available trial registry of all CSL-sponsored clinical trials and applicable observational/non-interventional studies (NIS); and
  • The reporting of results of completed CSL-sponsored clinical trials and applicable observational studies/NIS on a results database or equivalent website, according to regulatory requirements. Results are made publically available, regardless of outcome.

The pharmaceutical industry as a whole is working towards providing greater levels of public access to clinical trial data. CSL is undertaking work to ensure our disclosures will be compliant, at the very minimum, with the emerging requirements. In Europe, current requirements allow for the regulatory authority to release detailed information, including Clinical Study Reports and summary reports following agency decision on drug applications. CSL supports the release of those documents in full, including appendices, provided proprietary information and information that could compromise patient anonymity are redacted in line with relevant data protection legislation. Furthermore, as these requirements evolve, CSL will continue efforts to comply in a timely manner with national and international statutory requirements regarding disclosure of individual patient data and the right of patients to privacy.

Expanded Access

CSL is committed to developing innovative medicines for rare or life threatening conditions. These efforts include conducting clinical trials to rigorously assess the safety and efficacy of investigational medicine. CSL clinical trials are carefully designed, supervised, monitored and documented in compliance with the requirements of applicable regulatory authorities and are overseen by an independent review or ethics committee.

At CSL we are driven to complete our clinical programs and seek health authority approval for our new and innovative medicines with a sense of urgency.

It is important to note that investigational medicines have not received required health authority (e.g., US Food and Drug Administration) approval, and until completion of clinical research, their benefit risk profile is not fully understood. With this in mind, CSL only supports providing access to its investigational medicines in the context of a CSL clinical trial.

Individuals interested in accessing our investigational medicines may be eligible to participate in a clinical trial and we would encourage those persons, their caregivers and their physicians, to look at or for information on our clinical trial programs. We are grateful to those who participate in clinical trials to help us better understand and improve the future of public health.

CSL regularly reviews this policy and will update this webpage with any future changes.

Informed Consent

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.

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.

Terms of Reference for Animal Ethics Committee (Australia)

CSL and Stem Cell Research

CSL does not use embryonic or foetal stem cells in its current research program. 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.