Poor quality Asian clinical trials must end

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The need for a clinical trial research methodlogy training programme in Hong Kong

Training courses in the concepts of clinical trials research methodology that include rules in good clinical practice have not yet been extensively implemented in Hong Kong. This study aims to define the current knowledge of rules in good clinical practice and identify any need for such training programmes. Between May and August 1996, 161 clinical research staff were asked non-randomly to fill in a questionnaire about their knowledge of research methodology and their interest in specific courses. The median number of correctly answered questions (maximum score, 20) was 5 and the mode was 4, which was the expected score if questions had been answered randomly. Only minor differences in score were detected between doctors, research staff, and industry employees. Many researchers were keen, however, to further their knowledge by attending future courses; on average, each person showed an interest in three of the eight proposed courses. The study shows that the knowledge of rules in good clinical practice among clinical research staff in Hong Kong is poor, but there is nevertheless a demand for training programmes.published_or_final_versio

Prevalence and definition of childhood obesity

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Birth weight and adult lung function in China [4]

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Spirometric values in normal Chinese children and adolescents

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Clinical research practice

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Study site standard operating procedures

published_or_final_versionICH GCP E6 guidelines 193Clinical proceduresAppendicesPreparation of clinical trial protocol and protocol amendments 1Quality assurancePre-study visit 9Study closureTrial operationReview and validation of clinical trial protocol 14Introduction vReview of protocol amendments 22Review of investigators brochure 26Review of case report form 31Contracts and budgets 35Study organisation and planning 40Study team : definition of responsibilities 58Pre studyRecruitment of subjects 62Pre-study planning of investigational products and devices 68Pre-study planning for laboratory investigations 73Independent ethics committee or institutional review board 78Investigator meeting and GCP training 86Pre-study checklist 89Site initiation visit 93Blinding : codes and code breaking 101Investigational products accounting and dispensing 104Case report form completion 110Obtaining written informed consent 114Adverse event and serious adverse event reporting 129Monitoring visits 134Data clarification 139Study closure visit 145Archiving of study data 149Independent data monitoring 155Audits 158Inspections 164Measurement of blood pressure 171Spirometry testing 175Measurement of body weight and height 178Venepuncture (adults) 182Preparation and approval of SOPs 187Format for investigators CV 188Declaration of Helsinki 19

Earthworm extract as a fibrinolytic agent in healthy men: a randomised, double-blind, placebo-controlled study

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Preliminary results of prevalence study of obstructive sleep apnoea in middle-aged Chinese in Hong Kong

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Effect of Qigong on hypertension: a randomised controlled study

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