A DHB Perspective on Capturing Clinical Trial Value in Auckland

Abstract

Auckland has been a popular site for sponsors in carrying out clinical trials. Recently however this competitive edge has decreased due to increased competition from new countries within the industry. Therefore research has been carried out around the clinical trial environment in Auckland. It was seen from previous that DHB bureaucracy was a major barrier in the clinical trial environment. However there was no literature on what DHB’s thought about clinical trials and what their perceptions were on how to create a better clinical trial environment. The main aims of this study were to understand how clinical trials are run within the DHB, what the motivations of carrying out clinical trials are within each DHB and which barriers exist in each DHB. In order to acquire this information, nine semi-structured interviews were carried out with key personnel in the clinical trial environment in the three Auckland DHBs. The data showed that each DHB had different research structures however very similar approval processes. In WDHB and ADHB the research structures are set up to allow PIs to drive sponsor led clinical trials through the approval process thus giving total control of the trial to the PI. However in CMDHB another entity known as CCRep was created to deal with sponsor led clinical trials with the employees of CCRep carrying out the approval process. It was shown that the motivation for carrying out trials is patient led in all DHBs however CCRep has an additional motivation of creating a surplus for PIs to use in their own investigator led clinical trials. Lastly three main barriers were seen to hinder the clinical trial environment within the DHBs these were a lack of recognition that research is important within the DHB, the HDEC review process not being sufficient enough to protect patients and communication breakdowns between the various parties involved in a clinical trial. It is recommended that benefits of clinical trials must be shown to the wider DHB community which will allow research to become more accepted within the DHB. Along with this processes need to be standardised and a central portal should be created which will contain information about all aspects of a trial thus allowing parties to understand the research process within DHBs.