1.6 Clinical studies
To offer innovative medicines to people living with severe chronic diseases, UCB conducts many R&D activities. The clinical studies comply with Good Clinical Practice (GCP) standards to protect the safety, well-being and confidentiality of our patients and the integrity of the clinical study data, regardless of phase or location where the studies are conducted.
Patients are enrolled in clinical studies that are consistent with the principles that have their origin in the Declaration of Helsinki and its amendments as well as the laws, regulations and provisions of those countries where humans are enrolled.
Clinical study protocols are evaluated and approved for ethical acceptability and scientific validity by internal and external evaluation and by Advisory Committees. Volunteers in UCB’s clinical studies receive a detailed informed consent, receive a full explanation of the study purpose, methods and reporting, expected benefits and disadvantages, information on compensation for health impairment, option to withdraw at any time, and other details. In addition, special emphasis is provided on the education and training of the institutional and UCB study supportive staff involved. Pre-study audits and monitoring of the medical institutions are performed to ensure full GCP.
Study data are managed appropriately to protect the human rights, privacy and confidentiality of the personal data of the study volunteers.
UCB is committed to transparency, providing disclosure and sharing of clinical study data. UCB’s commitment posted on UCB.com to submit results from all studies for publication in peer-reviewed journals and adherence to international standards, such as International Committee of Medical Journals Editors (ICMJE) and Good Publication Practices for Communicating Company-Sponsored Medical Research (GPP3A).
UCB’s Clinical Trial Data Transparency Policy on disclosure of clinical study data govern the timely release of data as to maximize the value of the research for the benefit of the patients. In 2018, two important events illustrate UCB’s commitment to transparency of clinical study data with UCB hosting the Clinical Study Data Request Steering Committee (CSDC) of which the company is part since 2014 and being actively engaged in the PhRMA/EFPIA Principles for Responsible Clinical Trial Data Sharing initiative of sharing anonymized patient-level data and redacted study documents with external stakeholders.
Moreover, transparency and closing the gap in reporting clinical trials on public databases, such as the most widely used ClinicalTrials.gov is important for UCB. Timely disclosure of clinical trial information is essential to advancing medical understanding, to closing the gap in reporting positive and negative clinical data and to helping improve lives of those living with severe diseases. Beyond legally-defined ethics, compliance and timeline boundaries, UCB believes in Transparency WithInSight – which is about balancing transparency and need for data exclusivity – for the ultimate benefit of patients.
Animal studies are a critical aspect of medical research, both for generating new breakthroughs in experimental research and to ensure maximum safety of new treatments before they are used in human subjects. However, animal use is only permitted at UCB where there is no alternative, either because we need to generate essential information that can only be obtained from the whole body or because it is a regulatory authority legal requirement. UCB acts as a responsible company in the management of animal welfare, and both UCB’s research units involved in animal studies adhere to strict animal welfare standards and policies. These are regularly reviewed for potential areas for improvement, in line with current best practice.
UCB is committed to the responsible and appropriate use of animals in medical research, and complies with all applicable laws, regulations and industry standards. There are two research sites in UCB (UK and Belgium) that conduct studies with animals and both operate in full compliance with EU directive 2010/63/EU on the protection of animals used for scientific purposes. UCB also ensures that any work conducted externally on its behalf at Contract Research Organizations and external academic partners is, at a minimum, conducted in compliance with local animal welfare legislation and with UCB’s requirements for animal welfare. UCB will not place animal studies in institutions where the animal welfare standards are considered inadequate.
Wherever possible, UCB is also committed to the 3Rs in animal testing (replacement of animals in research with non-animal alternatives, reduction of the number of animals required to achieve scientifically robust results and refinement of procedures to minimize suffering) and continually monitors for opportunities for improvement in this area. UCB is actively involved with NC3Rs (U.K. National Council for Replacement, Refinement & Reduction of Animals in Research), for example by co-funding a program manager to oversee several 3Rs based projects in the pharmaceutical field and by membership of various NC3Rs working groups. UCB is also involved in other consortia working either directly or indirectly in the 3Rs.
The two UCB research sites that conduct animal studies also have local Animal Welfare and Ethics Committees that carefully consider whether the use of animals for particular research activities is necessary and justified, whether an appropriate animal alternative exists and should be used instead and whether any potential suffering has been adequately minimized. They also act to promote the 3Rs and ensure compliance with the highest standards of welfare and care, as well as reviewing and approving all newly proposed internal project licenses involving animals at their site.
Research site in Slough (U.K.)
In addition to EU directive 2010/63/EU, the research site in Slough (U.K.) is in full compliance with the U.K. Animals (Scientific Procedures) Act 1986. The Home Office’s Animals in Science Regulation Unit regularly visits the site, often unannounced, to ensure that high animal welfare standards are maintained.
UCB is also one of over 100 companies who has signed the U.K. Concordat on Openness on Animal Research. Signatory companies commit to ensuring that members of the public have accurate and up-to-date information about what animal research involves and the role it plays in the overall process of scientific discovery and treatment development, how such research is regulated in the U.K., and how researchers and animal care staff promote animal care and welfare, reduce animal usage and minimize suffering and harm to the animals.
Research site in Braine-l’Alleud (Belgium)
In addition to EU directive 2010/63/EU, the Belgian research site in Braine-l’Alleud (Belgium) has received accreditation from the Association for Assessment and Accreditation of Laboratory Animal Care International (AAALAC). This private non-profit association promotes the responsible treatment of laboratory animals through voluntary accreditation and assessment programs, and AAALAC accreditation represents a label of quality and of high professionalism in terms of animal care and use. AAALAC accreditation also fosters continuous improvement of scientific excellence in animal experimentation and research.
Animals used for research in 2018
During 2018, UCB used a total of 17 020 animals both at our own research sites and at external contract research organizations. With its continued commitment to the progressive implementation of in silico and in vitro technologies, UCB continues to take every opportunity to decrease the number of animals used in research studies.
A total of 97.6 % of all animals used by UCB researchers and contractors are rodents, with non-human primates, dogs, llamas, mini-pigs and rabbits accounting for the remaining 2.4%.