EVOLUTION OF MEDICAL RESEARCH REGISTRY IN A DEVELOPING COUNTRY: MALAYSIA

被引:0
|
作者
Thandapani, Revathy U. [1 ]
Sivasangari, S. [2 ]
Haniff, Jamaiyah [3 ]
机构
[1] Hosp Seberang Jaya, Clin Res Malaysia, Permatang Pauh, Malaysia
[2] Hosp Pualau Penang, Clin Res Ctr, George Town, Malaysia
[3] Hosp Kuala Lumpur, Clin Epidiamol Unit, Clin Res Ctr, Kuala Lumpur, Malaysia
关键词
Medical Research; Registry; Ethic Approval; Regulatory; Go Green; Online Registration; NMRR;
D O I
暂无
中图分类号
T [工业技术];
学科分类号
08 ;
摘要
The International Committee of Medical Journal Editor (ICJMJE) members require all clinical trials to register as a condition for publication. This policy applies to clinical trial starting enrolment after July 1, 2005. The National Medical Research Register (NMRR) was designed to meet this requirement yet extending it to include all types of medical research beyond clinical trials. Characteristics and flow of registered medical research as reported in the NMRR system is analysed; in terms of time trend time and differences in characteristics as a function of clinical specialty. A dataset comprising all research registered from year 2007 until 2012 in NMRR was downloaded on 26 Dec, 2012, and entered into a relational database to analyze aggregate data. The number of registered researches in NMRR system increased from 206 (September 2007) to 5107 (September 2007-Dec 2012), and the number of missing values in the data elements has generally declined. Most researches registered are those from student (57%; 2888/5107) and the rest from Ministry of Health (MOH) site researches (43%; 2219/5107). Most of the Interventional trials were phase III (56 %) and very small number of phase I. Heterogeneity in the reported methods by clinical specialty, sponsor type, therapeutic area, disease area, and research type was evident.
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页码:107 / 119
页数:13
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