Selecting a trial location
We conduct an increasing number of our clinical trials at multiple sites in several different countries. A broad geographic span helps us to ensure that those taking part in our studies reflect the diversity of patients around the world for whom the new medicine is intended. This approach also helps to identify the types of people for whom the treatment may be most beneficial.
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’ areas. We only conduct studies in countries where there are regulatory bodies and / or independent ethics committees who authorise all studies that take place and approve the protocols for all clinical trials.
Our global governance process for determining where we place clinical trials provides the framework for ensuring a consistent approach worldwide. We take several factors into account when choosing locations for a trial:
- Infrastructure – we only conduct trials in countries where there are experienced and independent ethics committees and a robust regulatory regime.
- Facilities and training – there must be adequate numbers of trained healthcare professionals, and well-equipped hospitals and laboratories.
- Availability of patients – there must be sufficient numbers of patients willing to participate in a trial.
- Prevalence of disease – some diseases are more prevalent in particular countries or regions.
- Current medical treatment – trials often compare a new compound against current treatments. We select locations where the treatment we wish to test against is commonly used.
- Cost efficiency – as part of an increasingly stringent regulatory approval process, regulatory authorities are requiring us to conduct more trials involving greater numbers of patients. This inevitably has an impact on costs and so we include cost considerations in the selection of a trial location. Cost efficiencies must however always be achieved without compromising either our ethical commitment to participants or the quality of the research.
- Local regulatory requirements – in some countries, regulatory authorities require trials to be carried out locally before a new medicine can be submitted for regulatory approval.
How do you ensure consistent standards in different locations?
Our standards are global and apply to all AstraZeneca clinical trials, in all locations, whether they are being conducted by us or on our behalf by third party contract research organisations. If our policies differ from local regulations, we adopt whichever standard is higher. Our Standard Operating Procedures and Policies require that all staff involved in clinical trials and all investigators are trained in ICH guidelines and local Good Clinical Practice regulations. Our associated compliance assurance process spans all areas of our business to ensure compliance in all countries.
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