Clinical trials in New Zealand--an update.

作者
Currie,Andrew Jull
出处
期刊:PubMed [National Institutes of Health]
卷期号:125 (1353): 22-9 被引量:4
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AIMS: 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. METHODS: 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. RESULTS: 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%). CONCLUSIONS: 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.

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