TY - JOUR
T1 - Clinical trials in New Zealand
T2 - Progress, people, and policies
AU - Lockhart, Michelle Marie
AU - Babar, Zaheer Ud Din
AU - Garg, Sanjay
PY - 2011/6/1
Y1 - 2011/6/1
N2 - Competition for clinical trial projects outsourced by the global pharmaceutical industry is increasing with more countries bidding to provide these services. A comprehensive review of the clinical trial landscape in New Zealand was conducted by analysing clinical trial applications, and interviewing senior industry representatives on their expertise, capabilities, knowledge management, and innovative behaviours, as well as the policies and factors that had influenced the development of the industry. The number of clinical trial application approvals increased from 33 in 1989/1990 to 113 in 2008/2009 indicating continued confidence of the pharmaceutical industry in placing clinical research projects in New Zealand. Much of this growth has been due to an increasing number of phase I and II trials as a result of the availability of new purpose-built facilities. The sponsors of clinical trials in New Zealand have changed from predominantly representatives of the pharmaceutical industry to mainly local and overseas CROs. The industry representatives are very experienced with the range of capabilities expected for clinical trials. They prefer informal sources of knowledge acquisition and display innovative behaviours such as solving problems that cause others difficulty, teamwork, and project planning. A large number of factors have encouraged the clinical trials industry in New Zealand including quality sites and data, the western healthcare system, the high incidence of some diseases, and seasonal opposition to Europe and the United States. Respondents suggested policies and strategies to address the increasing threat from global competition. New Zealand has developed significant expertise in clinical research but it should continue to monitor its industry to ensure continued growth.
AB - Competition for clinical trial projects outsourced by the global pharmaceutical industry is increasing with more countries bidding to provide these services. A comprehensive review of the clinical trial landscape in New Zealand was conducted by analysing clinical trial applications, and interviewing senior industry representatives on their expertise, capabilities, knowledge management, and innovative behaviours, as well as the policies and factors that had influenced the development of the industry. The number of clinical trial application approvals increased from 33 in 1989/1990 to 113 in 2008/2009 indicating continued confidence of the pharmaceutical industry in placing clinical research projects in New Zealand. Much of this growth has been due to an increasing number of phase I and II trials as a result of the availability of new purpose-built facilities. The sponsors of clinical trials in New Zealand have changed from predominantly representatives of the pharmaceutical industry to mainly local and overseas CROs. The industry representatives are very experienced with the range of capabilities expected for clinical trials. They prefer informal sources of knowledge acquisition and display innovative behaviours such as solving problems that cause others difficulty, teamwork, and project planning. A large number of factors have encouraged the clinical trials industry in New Zealand including quality sites and data, the western healthcare system, the high incidence of some diseases, and seasonal opposition to Europe and the United States. Respondents suggested policies and strategies to address the increasing threat from global competition. New Zealand has developed significant expertise in clinical research but it should continue to monitor its industry to ensure continued growth.
KW - capability
KW - clinical research
KW - clinical trials
KW - expertise
KW - policy
UR - http://www.scopus.com/inward/record.url?scp=79959669793&partnerID=8YFLogxK
U2 - 10.1002/ddr.20437
DO - 10.1002/ddr.20437
M3 - Review article
AN - SCOPUS:79959669793
VL - 72
SP - 299
EP - 304
JO - Drug Development Research
JF - Drug Development Research
SN - 0272-4391
IS - 4
ER -