Abstract:
Clinical trials research is a regulatory requirement for businesses seeking approval to market pharmaceutical medicines and medical devices to ensure that these products are safe and effective prior to public use. Auckland competes internationally as a destination for clinical trials, but there have been no studies to date of Auckland’s clinical trial business sector. The aims of this study were to understand the current status and capabilities of the commercial clinical trials sector in Auckland, and to identify opportunities for growth by capturing offshore business. Qualitative data was collected during eleven semi-structured interviews with senior representatives from Auckland organisations active in clinical trials research. The study sample represented approximately half of these organisations. Study data showed that Auckland has expertise in a wide range of therapeutic areas. Participants agreed that Auckland had an excellent and growing reputation for early phase work, which currently is conducted mainly in one privately owned specialist unit. They identified DHB bureaucracy as the main barrier to business, with studies often being lost offshore. Apart from offshore competition, the main threat to the Auckland clinical trials industry was thought to be a merger of the Australian and New Zealand regulatory systems. The study revealed that Auckland has highly experienced, passionate and business minded people within the clinical trials industry, allowing it to flourish. Opportunities for growing the clinical trial industry in Auckland included the expansion of Phase I capacity and the effective capture of value from clinical testing and development of medical devices from offshore companies.