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.
Conducting Clinical Trials
CSL Behring 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 Behring 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 Behring’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.
Clinical Trial Transparency
CSL Behring recognizes that there are important public health benefits associated with making clinical trial information widely available to practicing physicians, patients and patient associations. CSL Behring 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 Behring makes every effort to comply with national and international standards relevant to clinical trial disclosure and data.
To this end, CSL Behring is committed to:
- The prospective registration on a publicly available trial registry of all CSL Behring-sponsored clinical trials and applicable observational/non-interventional studies (NIS); and
- The reporting of results of completed CSL Behring-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 Behring has in place policies and procedures that 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 Behring 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 globally, CSL Behring 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.
CSL and stem cell research
CSL Behring does not use stem cells in its current research program. However we recognize 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 Behring constantly monitors developments in this area.
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.