A candidate medicine enters clinical development (testing in man) only after we have confirmed its potential efficacy and safety in pre-clinical trials, which include animal testing. Clinical studies are a significant undertaking, including extensive collaboration with clinicians in many countries and involving thousands of people (both healthy volunteers and patients).
Most of our clinical trials are global in nature. By conducting our studies across a broad geographic span, we aim to ensure that those taking part fully represent the diversity of the patient populations around the world for whom the new medicine is intended. This approach also helps to identify those for whom the treatment will be most beneficial.
Currently, we only do studies in countries ranked in the United Nations Development Program ‘Human Development Index’ as ‘High human development’ and ‘Medium human development’. We conduct no studies in ‘Low human development’. In addition to the global studies conducted by our global clinical organisation, our local clinical organisations run national trials when needed (and in some countries, regulators require local trials as part of the process for approving a new medicine for marketing).
We take very seriously our responsibility to deliver the highest standards of ethical practice when conducting clinical studies. We comply with all relevant laws and regulations of the country or countries in which our trials are being conducted, and we have our own strict policy and standards, which are in line with international codes such as ICH1 and the Declaration of Helsinki. When conducting a trial anywhere in the world, we operate to the highest of the standards required by the external international, regional or local regulations, or our own internal standards.
All trial proposals are first subject to stringent internal review, including consideration of the pre-clinical data and how safe the trial process is for those taking part. Before it can begin, each trial must be approved by the appropriate external independent ethics committee or institutional review board, and the relevant regulatory agency.
Our commitment includes strict guidelines to ensure that those taking part in trials understand their nature and purpose and are not exposed to unnecessary risks, and that the privacy of participants’ health information is protected. We also ensure that proper procedures are in place for gaining informed consent from participants, including appropriate ways of dealing with any special circumstances, such as different levels of literacy.
Some of our medicines, such as asthma therapies, are designed to treat children as well as adults. Sometimes a child can receive a reduced adult dose of a medicine, adjusted according to body weight, but in many other ways, children are not miniatures of grown-ups. Normally, every medicine must be studied separately in children to ensure factors that vary according to age, such as liver and kidney functions, are accounted for in establishing the right dose. When children are involved in a clinical trial, we work with experienced child healthcare professionals to ensure that the information provided for the volunteer, and for the parents who give the informed consent, is appropriate to the age of the child. Informed consent procedures are specifically included in our audit processes described below.
The percentage of clinical studies run for us by third parties varies depending on the number of trials we have underway and the amount of internal resource available to do the work. On average, approximately 35% of our studies (which are always designed by AstraZeneca) involve contract research organisations (CROs) and we contractually require them to operate to the same standards that we apply in-house.
Our Clinical Quality Assurance teams conduct a wide range of audits of, and formal visits to our clinical research related activities whether they are being done in-house or by a CRO. This includes audits at investigator trial sites covering clinical trial documentation as well as audits of systems and processes.
As part of our commitment to provide patients and healthcare professionals with meaningful information about our products, we make details about our clinical trials available on public websites. At the end of 2007, we had published information on the registration and results of more than 400 trials. These include hypothesis testing1 trials, trials conducted in patients with a serious or life-threatening disease or condition, and non-interventional studies as defined by AstraZeneca.
In May 2008, we extended the scope of our disclosure to include information about the registration and results of all AstraZeneca sponsored clinical trials for all products in all phases, including marketed medicines, drugs in development and drugs whose further development has been discontinued. Our commitment to publishing results, irrespective of whether they are favourable or unfavourable to AstraZeneca, remains unchanged. Basic information on new trials is published on our dedicated clinical trials website with more details presented on the US National Library of Medicine's website. Any new trial is added within 21 days of the start of patient enrolment.
Results of trials with already marketed medicines are published within one year of completion and results of trials with medicines in development will be published within 30 days of first regulatory approval for the new medicine or, when development has been discontinued, within one year of the public announcement of the decision. For marketed medicines and recently approved medicines where we consider there to be good cause to delay posting of results, we will seek necessary approval according to applicable law. Where approved, we post a brief explanation for the delay and the anticipated date when the results will be posted. Results are posted on our clinical trials website, the US National Library of Medicine's website and, for US approved medicines, the PhRMA website. Information is also provided on the International Federation of Pharmaceutical Manufacturers and Associations (IFPMA), which provides a single entry to trial registration and results information across the pharmaceutical industry.
Because we operate in an ever-changing environment, we will continue to monitor closely developments and advances in this area to ensure that AstraZeneca remains at the forefront of best practice in clinical trial transparency.
1Trials that are conducted to provide firm evidence to support safety and efficacy claims.
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