Clinical trials in New Zealand--treading water in the knowledge wave?

AIMS

To describe the number and type of clinical trials in New Zealand 1998-2003, and to identify the number of trials for which approval was sought in 2003 that were listed with trial registries.

METHODS

Annual reports (1998-2003) from all regional ethics committees were reviewed for clinical trials. Trials must have been referred to as phase I, II, or III clinical trials; employ descriptors such as randomised controlled trials or controlled trials; or been known to the authors as randomised controlled trials. Trials registers at ClinicalTrials.gov, Current Controlled Trials, NHMRC Clinical Trials Centre, National Cancer Research Network, CenterWatch, Trans-Tasman Radiation Oncology Group, as well as industry registers were searched using keyword identifiers for the trials submitted for ethical review in 2003.

RESULTS

Ethics approval was sought for 665 clinical trials (1998, 118 trials; 1999, 91 trials; 2000, 103 trials; 2001, 104 trials; 2002, 108 trials; 2003, 141 trials). The majority of applications (481, 72%) were submitted to either the Auckland or Canterbury committees. 581 (87%) applications were for phase III trials. 522 (78%) applications were for trials involving pharmacological agents, and 115 applications (17%) were for trials involving procedures, processes, or medical devices. The remaining 28 applications (4%) involved interventions such as diet, complementary therapies, or dental care. Of all applications, 332 (50%) were in the fields of cancer, cardiovascular disease, and respiratory disease. Only 45 (32%) of the 141 trials submitted for review in 2003 were listed in a public domain register.

CONCLUSIONS

The number of randomised controlled trials (RCTs) in New Zealand has not clearly increased in recent years despite the greater than ever need for such evidence. Information currently in the public domain could support registers of clinical trials.