Clinical Trials Directive Still Hampering Academic Medical Research
The News Review:
- Clinical Trials Directive Still Hampering Academic Medical Research
- Report Assails FDA versight of Clinical Trials
- Malaysia Thailand To Draw Up Standard Procedure To Control Avian Flu
Clinical Trials Directive Still Hampering Academic Medical Research
Medical News Today – Medical News Today (press release) – Sep 28, 2007
The work is a first attempt to create a comprehensive picture at EU level of the outcome of the Directive three years after its coming into force” he said. “Because the follow-up time is quite short it is still difficult to report final outcome figures particularly given that some countries such as France and The Netherlands did not fully implement the Directive until 2006. But the data for non-commercial clinical research in general confirms that academic research which represented around a quarter of all clinical trials of drugs before implementation lost ground and represents now less than one fifth of newly started trials. ” Although the size of the effect is below initially reported estimates from different sponsor organisations the current trend remains negative. However latest figures reported by national authorities indicate that the pre-implementation level for new clinical trial authorisations may be achieved again in the coming 12 months at least for commercial trials. Because the Directive changed the standards for trial reporting many countries had to revise their way of compiling data and as a result the pre- and post-implementation statistics are not fully comparable. During the pre-implementation period most authorities did not report many details.
Report Assails FDA versight of Clinical Trials
New York Times – Sep 28, 2007
Animal research centers have to register with the federal government keep track of subject numbers have unannounced spot inspections and address problems speedily or risk closing none of which is true in human research Mr. Because no one collects the data systematically there is no way to tell how safe the nation’s clinical research is or ever has been. The drug agency oversees just the safety of trials by companies seeking approval to sell drugs or devices. Using an entirely different set of rules the ffice for Human Research Protections oversees trials financed by the federal government. Privately financed noncommercial trials have no federal oversight. “It’s crazy that we have all these different sets of rules” said Dr.
Malaysia Thailand To Draw Up Standard Procedure To Control Avian Flu
Bernama – Bernama – Sep 28, 2007
“Thailand which is doing well in the health tourism industry receives about two million health tourists annually compared with only 300000 annually in Malaysia at present” he added. Given that Malaysia particularly Kuching was leading the drive to promote Malaysia as a regional clinical trial hub he said traditional and complementary medicine were other potential areas of cooperation. The new Clinical Research Centre (CRC) at the Sarawak General Hospital (SGH) here the first such facility in the country is expected to propel the thrust into biotechnology and clinical research upon its completion in two years’ time. Apart from embarking on joint studies on the burden of diseases and injuries as well as national health accounts the conference also deliberated on awareness and capacity-building pertaining to intellectual property rights over health products. Dr Chua said the next joint health conference to be held in Thailand in 2009 would be renamed the First Bilateral Malaysia-Thailand Health Ministers’ Meeting.
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