The Australian clinical trials sector has grown steadily over the past decade, particularly with respect to early phase trials where Australia's research capacity, capability and quality of research is revered. With an increase in the number of internationally sponsored clinical research projects being conducted in Australia, particularly in the early phase setting, there has been a corresponding growth in the number of clinical research sites conducting early phase clinical trials. Australian researchers are guided by a multitude of research codes, guidance and statements which govern the conduct of clinical trials. Although international guidance regarding the conduct of early phase clinical trials exists, there is currently no single source outlining best practice recommendations for the conduct of early phase clinical trials in Australia. In recognition of this Clinical Trials: Impact & Quality (CT:IQ), a collaborative of sector stakeholders, convened a project team with comprehensive knowledge of the Australian clinical trials sector and particularly early phase research, to evaluate and collate broadly applicable and implementable guidance for the conduct of early phase clinical trials. Although the initial intent was to create guidance specific to early phase, we recognize the project outcomes are more broadly implementable irrespective of the research phase and are intended to support all clinical research sites to conduct high-quality clinical trials in Australia.
Various practical problems associated with cooperative therapeutic trials are discussed from the experience obtained during the U. S. Veterans Administration Cooperative Study on Antihypertensive Agents. The problems discussed include stratification of patients on the basis of severity, methods and precautions for achieving double-blind _ therapeutic regimens, methods for obtaining uniformity of data in different hospitals, and the need for inserting modifications in the protocol to take care of the patients developing life threatening complications.Other practical problems discussed include the need for obtaining the cooperation of the ward physicians and the problem associated with defaulters and those who do not follow the prescribed regimens. Experimental design helps to restrict errors introduced by variance between hospitals. Cooperative trials have goals and use methods which are somewhat different from the classical methods and aims of laboratory research, and should be evaluated in their proper frame of reference.
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