Clinical trials in New Zealand--an update

To describe clinical trial activity in New Zealand for the period 2005-2009 and estimate the number of trials that were listed on World Health Organization-compliant trials registers.

Clinical trials were identified from the annual reports (2005-2009) of the six Health and Disability Ethics Committees. To be included, trials must have been referred to as phase I, II, III or IV trials; or included key descriptors in the title; or have been known to the authors as randomised controlled trials. Key trial characteristics were obtained from searching trials registers or through contact with the investigators.

900 clinical trials were approved in the period 2005-2009 (average 180 per year). The Multi Region ethics committee received most of the applications (379, 42%) followed by the Northern X (190, 21%) and Northern Y (151, 17%). 621 (69%) trials were late phase trials (average 124 per year) and 279 (31%) were early phase trials (average 56 per year). Most trials involved a drug (651, 72%). Trials that recruited infants, children or adolescents accounted for just 68 trials (8%). The most frequent conditions targeted were cancer (163, 18%), cardiovascular disease (125, 14%) and respiratory disease (83, 9%). 532 (59%) trials were commercially sponsored and 335 (37%) were non-commercial. Merck Sharp and Dohme were the single most frequent commercial sponsor (50, 9% of commercial trials) and the Health Research Council the single most frequent non-commercial sponsor (70, 21% of non-commercial trials). 758 (84%) trials could be identified as being listed on a WHO-compliant trials registry. Non-commercially sponsored trials had lower rates of registration (278, 83%) than commercially sponsored trials (480, 90%).

Clinical trial activity in New Zealand has increased compared with the period 1998-2003 and early phase activity accounted for most of the increase. There has been a dramatic rise in trials registration and the commercial sector has been more compliant with the International Committee of Medical Journal Editors' statement on trials registration than the non-commercial sector.