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If we are unable to take advantage
of advances, patients will not have the best treatments. We understand
concerns about technological advances in the R&D process, and
welcome informed debate.
The R&D process is highly regulated, wherever
we operate. As scientific advances raise new issues, we work closely
with the regulators, policy makers and stakeholders to develop any
new or refined standards. We have our own internal standards and
systems to ensure that we comply with or exceed all guidelines,
regulations and legal requirements.
THE ESSENTIAL ROLE OF ANIMAL
RESEARCH
 Basic
research using animals is vital to furthering our understanding
of human disease. Animal studies also provide an essential bridge
between characterising potential new medicines and vaccines in the
laboratory and learning about their effects in people. By law, we
must assess drug safety in animals before starting clinical trials.
We are committed to the three Rs – to reduce, refine and replace
animal studies – and set stringent standards internally and
for our external contractors. We ensure that all GSK staff conducting
animal studies are thoroughly trained.
We reduce the number of animals used in research wherever
we can without compromising the safety of volunteers and patients
in clinical trials, and we seek as much information as possible
from each animal study. The number of animals used in our laboratories
has therefore remained essentially constant over the last eight
years in spite of a significant increase in our R&D activity
(see chart below). We use animals more humanely
by using, for example, non-invasive imaging.
We encourage staff to devise alternative approaches
to animal research through internal Animal Welfare Awards. GSK sponsors
the largest European award in this field – the GSK Laboratory
Animal Welfare Prize22.
Inspections by national regulatory authorities acknowledge the high
standards of care and compliance in our facilities. To ensure that
we meet best practice, our US and UK animal facilities are accredited
by the Association for Assessment and Accreditation of Laboratory
Animal Care23,
and we are working to extend this to our other facilities.
We believe that the best way to address public interest
in animal research is to foster greater knowledge and understanding
of the facts. We also believe that this is the most effective way
to help combat the climate of fear and intimidation being promoted
by animal extremist groups. We therefore provide information to
support rational public debate, actively participate in such discussions
ourselves and host tours of our animal facilities where possible.
We also welcome government actions to protect our staff, laboratory
animals and research collaborators from extremist actions. We visit
schools to discuss relevant ethical issues, for example, involving
over 2000 UK pupils in such discussions in the 2001-2 school year.
Information on GSK’s use of animals in research
is available on our website24.
TESTING NEW MEDICINES IN CLINICAL
TRIALS
GSK’s aim, to develop medicines and vaccines that benefit
patients, is reflected in the priority we give to protecting the
interests of healthy volunteers and patients who take part in our
clinical trials. The regulatory authorities rigorously scrutinise
the initiation and conduct of clinical trials and related activities.
The need to respect the rights, dignity, safety and well-being of
clinical trial participants is enshrined in declarations and guidelines
produced by the World Medical Association, World Health Organization,
Council of the International Organisations of Medical Sciences,
Council of Europe, the International Conference on Harmonisation
(ICH) and government bodies. GSK fully complies with the relevant
regulations and national requirements, and with guidelines such
as ICH Good Clinical Practice. When regulations and guidelines are
periodically reviewed and revised to ensure that they fully address
the interests of patients, GSK actively contributes to the discussions
on the basis of our extensive global experience.
In our last review, we summarised our rigorous procedures
to ensure patient safety and the privacy of their medical information.
We have recently strengthened procedures to avoid information being
sent to GSK by external investigators that would enable us to identify
trial participants. However, we know that the conduct of clinical
trials raises ethical issues and we therefore worked with other
companies in 2002 to establish the new PhRMA Principles on the Conduct
of Clinical Trials and Communication of Clinical Trial Results 25.
The Principles reflect the importance of independent
Institutional Review Boards or Ethical Review Committees in protecting
patients and volunteers involved in clinical trials. GSK fully supports
these guidelines, which reiterate the need to obtain genuinely informed
consent before any clinical procedure is undertaken, an obligation
that GSK extends to include acquiring and using human biological
samples such as tissues and DNA. The Principles also summarise the
safeguards the industry, including GSK, adopts to ensure that the
reimbursement of patients’ and external clinical investigators’
expenses is not an inappropriate inducement to participate in clinical
trials, or to bias the results that are reported. Regulatory authorities’
requirements for financial disclosure further protect the public
interest in this area.
The Principles articulate the industry’s, and
GSK’s, practice of seeking to publish the meaningful results
of controlled clinical trials, regardless of the outcome, in a timely
manner. This includes giving clinical trialists the appropriate
level of access to the raw data and their interpretation.
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