Clinical trials in Asia Pacific

The article provides information on biotechnology in Asia. According to research, Asian Pacific biotechnology is known for its competent staff, world class technologies, efficient utilities, and abundance of reasonably priced raw materials. Other attributes of the Asia Pacific region that makes it a sought-after location in conducting clinical studies are also discussed. Meanwhile, the role of Contract Research Organization (CRO) in clinical studies in the Asia Pacific region is also presented.

Banding and radio-tracking juvenile powerful owls in Melbourne, Victoria : trials and tribulations

The Powerful Owl (Ninox strenua) is Australia's largest owl. Considering their large size they are a very cryptic species, with limited sexual dimorphism, silent fight and a highly camouflaged presence amongst secluded canopy vegetation. These features enable Powerful Owl presence to often go unnoticed and even for the trained eye, extremely difficult to study. Our research has focused on monitoring the behaviour of individual Powerful Owls in urban Melbourne, Australia.
The leg banding of Powerful Owls is a somewhat contentious issue in Australia and here we report on the suitability of different types of legs bands placed on the tarsus of juvenile Powerful Owls. There has been some debate over the band size that should be used and the consequent effects bands may pose for the owls as they mature. We also investigate the usefulness of bands as a technique to identify Powerful Owls once they have dispersed from the natal territory.
Radio-tracking juvenile Powerful Owls was also undertaken during this study, primarily to determine individual behaviour from post fledging until dispersal. This is the first study in Australia to attempt radio-tracking juvenile Powerful Owls and the results from this research highlight behavioural characteristics, mortality rates post fledging and dispersal movements for the twelve months post fledging.
Overall we found that aluminium legs bands are a useful tool for individual identification of juvenile Powerful Owls post fledgling, however, their presence is somewhat difficult to determine on mature adults as the tarsus feathers tend to cover the band and make vision from the ground difficult. Aluminium leg bands are also useful as an identification tool for deceased birds. Leather leg bands are more suitable than aluminium bands when attaching radio-transmitters as these provide more flexibility and can be removed by the owl if they become irritating.
Radio-tracking juvenile Powerful Owls provided invaluable information relating to juvenile behaviour and movements, showing that juveniles actually remain in territories adjacent to their natal territory for the twelve months post fledging. This information is vital for the successful conservation of this species, particularly in relation to habitat conservation and home-range modelling.

Quality of reporting of randomized clinical trials in abstracts of the 2005 annual meeting of the American College of Rheumatology.

Objective: To determine the quality of abstracts reporting randomized clinical trials (RCT) at the 2005 Annual Scientific Meeting of the American College of Rheumatology.

Methods: All 2005 abstracts including late-breaking abstracts were assessed. An abstract was deemed to be reporting an RCT if it indicated that participants were randomized in the title or body of the abstract. RCT were excluded if they included only pharmacokinetic data. The CONSORT checklist was applied and relevant data extracted. We defined manufacturer support as acknowledgment of industry support or industry employee as co-author.

Results: Of 2146 abstracts, 143 (6.7%) reported RCT. Of these, 78.3% were drug trials, and 63.6% indicated manufacturer support. Only 30.8% of abstracts used "randomized" in the title, 44.1% did not explicitly state whether blinding was undertaken, and only 7.0% clearly stated who was blinded. Thirty percent of studies did not give an explicit definition of eligibility criteria of participants. While 84.6% explicitly described the experimental intervention, only 37.1% explicitly described the comparator intervention. Only 21% explicitly stated that an intention to treat analysis was performed. Baseline demographic and clinical characteristics were reported in 48.3%. While most abstracts reported summary results for each treatment group, only 35.7% reported effect size with its precision.

Conclusion: The quality of reporting is suboptimal in many RCT abstracts. Abstracts reporting RCT would benefit from a structured approach that ensures more detailed reporting of eligibility criteria, active and comparator interventions, flow of participants, and adequate summary and precision of results.

The effect of tai chi on psychosocial well-being : a systematic review of randomized controlled trials

Objective : This systematic review aimed to critically appraise published clinical trials designed to assess the effect of Tai Chi on psychosocial well-being.

Data Sources : Databases searched included MEDLINE, CINAHL, EMBASE, HEALT, PsycINFO, CISCOM, the Cochrane Central Register of Controlled Trials of the Cochrane Library, and dissertations and conference proceedings from inception to August 2008.

Review Methods : Methodological quality was assessed using a modified Jadad scale. A total of 15 studies met the inclusion criteria (i.e. English publications of randomized controlled trials with Tai Chi as an intervention and psychological well-being as an outcome measure), of which eight were high quality trials. The psychosocial outcomes measured included anxiety (eight studies), depression (eight studies), mood (four studies), stress (two studies), general mental health three studies), anger, positive and negative effect, self-esteem, life satisfaction, social interaction and self-rated health (one study each).

Results : Tai Chi intervention was found to have a significant effect in 13 studies, especially in the management of depression and anxiety. Although the results seemed to suggest Tai Chi is effective, they should be interpreted cautiously as the quality of the trials varied substantially. Furthermore, significant findings were shown in only six high quality studies. Moreover, significant between group differences after Tai Chi intervention was demonstrated in only one high quality study (the other three significant results were observed in non-high quality studies). Two high quality studies in fact found no significant Tai Chi effects.

Conclusion : It is still premature to make any conclusive remarks on the effect of Tai Chi on psychosocial well-being.

A simple parametric method for reducing sample sizes in gut passage time trials

Seed dispersal is now regularly analyzed using spatially explicit models, relying in part on frugivore gut passage times to produce model outputs. In determining species-specific gut passage times, there is a trade-off in sample size between minimizing collection effort and maintaining statistical reliability. Here we demonstrate that a two-parameter lognormal parametric distribution reliably fits empirical gut passage time distributions and is easily parameterized using relatively small data sets of approximately 30 defecations. We suggest this approach as a statistically reliable substitute for larger empirical gut passage data sets in seed dispersal modeling, and also as a way of using published gut passage data sets to parameterize new models.

Invited editorial presents an accurate summary of the results of two randomised placebo-controlled trials of vertebroplasty

Our recent editorial in the Journal presents an accurate summary of our two randomised trials of vertebroplasty, which found no benefit of vertebroplasty over placebo.

Participants in both trials are representative of patients seen in clinical practice and who would qualify for government-subsidised funding of vertebroplasty in Australia.

Clinical experience and previous published literature are likely to have overestimated the treatment benefit of vertebroplasty for many reasons.

This is why randomised placebo-controlled trials are required to determine the efficacy of treatment interventions, particularly when the condition being treated is self-limiting and the primary end point is improvement of symptoms.

Based on the best evidence currently available, the routine use of vertebroplasty outside of the research setting for painful osteoporotic vertebral fractures appears unjustified.

Reporting of the ACT heroin trials

The aim of this research is to analyse the reports of the proposed heroin maintenance trials in the Australian Capital Territory (A.C.T.), in Melbourne print media during 1997. The proposal for trials of heroin-prescription to long-term users in the A.C.T. was based on extensive scientific research. The rejection of this proposal by Prime Minister Howard raised many questions. This study was designed to help understand what discourses and rhetorical devices were used in the reporting of heroin issues in the media and what part some sections of the media played in the government’s decision. Discourse analysis was conducted of newspaper articles from two major Melbourne newspapers, The Age and the Herald-Sun for the year 1997. All articles relating to heroin and drug-policy from the newspapers were included for analysis. Those in favour of the trials used predominantly health and social discourses. Those opposed used moral discourses supported with stereotypes, metaphors, emotive practices and ‘inaccuracies’. There were considerable differences in discourses presented by The Age and the Herald-Sun. This study demonstrates that opposition to the heroin trials relied on rhetorical strategies and sensationalistic arguments, rather than meaningful debate of scientific and social issues. Researchers should act to identify the stereotypes and metaphors used in the discourses surrounding an issue and act to disarm them.