The current status of clinical trials in Malaysia

C. C. Lang

The current status of clinical trials in Malaysia

C. C. Lang

Research output: Contribution to journal › Article › peer-review

Abstract

Although Malaysia has a relatively long history of clinical research, its participation in international drug research is very recent. With the increasing widespread implementation of Good Clinical Practice (GCP) worldwide, there is mounting pressure for Malaysia to adopt GCP as part of its regulation of clinical trials. There will, however, be challenges in implementing GCP guidelines in Malaysia. The training of investigators, the proper functioning of research ethics committees, the practice of obtaining written informed consent, source data verification, and quality control with internal audit and official inspection are among some of the more difficult issues. Nevertheless, the obvious benefit of GCP is acknowledged not only by Malaysia's Drug Control Agency but also by the research community of Malaysia. With the increasing active participation of Malaysia in international drug research, the implementation of GCP warrants urgent attention.

Original language	English
Pages (from-to)	1243S-1246S
Number of pages	4
Journal	Drug Information Journal
Volume	32
Issue number	4 Suppl.
Publication status	Published - 1998

Access to Document

http://www.diahome.org/en-GB/News-and-Publications/Browse%20Articles.aspx?pubid=DIAJ&tse=0&dr=0&SortBy=yrgrp&Direction=desc

Cite this

@article{6faa404e00f9484aabc978183c7acfe6,

title = "The current status of clinical trials in Malaysia",

abstract = "Although Malaysia has a relatively long history of clinical research, its participation in international drug research is very recent. With the increasing widespread implementation of Good Clinical Practice (GCP) worldwide, there is mounting pressure for Malaysia to adopt GCP as part of its regulation of clinical trials. There will, however, be challenges in implementing GCP guidelines in Malaysia. The training of investigators, the proper functioning of research ethics committees, the practice of obtaining written informed consent, source data verification, and quality control with internal audit and official inspection are among some of the more difficult issues. Nevertheless, the obvious benefit of GCP is acknowledged not only by Malaysia's Drug Control Agency but also by the research community of Malaysia. With the increasing active participation of Malaysia in international drug research, the implementation of GCP warrants urgent attention.",

author = "Lang, \{C. C.\}",

year = "1998",

language = "English",

volume = "32",

pages = "1243S--1246S",

journal = "Drug Information Journal",

issn = "0092-8615",

publisher = "SAGE Publications",

number = "4 Suppl.",

}

TY - JOUR

T1 - The current status of clinical trials in Malaysia

AU - Lang, C. C.

PY - 1998

Y1 - 1998

N2 - Although Malaysia has a relatively long history of clinical research, its participation in international drug research is very recent. With the increasing widespread implementation of Good Clinical Practice (GCP) worldwide, there is mounting pressure for Malaysia to adopt GCP as part of its regulation of clinical trials. There will, however, be challenges in implementing GCP guidelines in Malaysia. The training of investigators, the proper functioning of research ethics committees, the practice of obtaining written informed consent, source data verification, and quality control with internal audit and official inspection are among some of the more difficult issues. Nevertheless, the obvious benefit of GCP is acknowledged not only by Malaysia's Drug Control Agency but also by the research community of Malaysia. With the increasing active participation of Malaysia in international drug research, the implementation of GCP warrants urgent attention.

AB - Although Malaysia has a relatively long history of clinical research, its participation in international drug research is very recent. With the increasing widespread implementation of Good Clinical Practice (GCP) worldwide, there is mounting pressure for Malaysia to adopt GCP as part of its regulation of clinical trials. There will, however, be challenges in implementing GCP guidelines in Malaysia. The training of investigators, the proper functioning of research ethics committees, the practice of obtaining written informed consent, source data verification, and quality control with internal audit and official inspection are among some of the more difficult issues. Nevertheless, the obvious benefit of GCP is acknowledged not only by Malaysia's Drug Control Agency but also by the research community of Malaysia. With the increasing active participation of Malaysia in international drug research, the implementation of GCP warrants urgent attention.

UR - https://www.scopus.com/pages/publications/0031772663

M3 - Article

AN - SCOPUS:0031772663

SN - 0092-8615

VL - 32

SP - 1243S-1246S

JO - Drug Information Journal

JF - Drug Information Journal

IS - 4 Suppl.

ER -

The current status of clinical trials in Malaysia

Abstract

Access to Document

Other files and links

Fingerprint

Cite this