Research and development: the need for proper safety and efficacy evaluation

Zakiah I., . (2000) Research and development: the need for proper safety and efficacy evaluation. [Proceedings Paper]

Traditional medicine especially with the use of herbal products has recently received global attention. The World Health Organisation WHO also actively promotes the use of traditional medicine if proven scientifically safe and efficacious. However due to various factors including lack of proper documentation most of the countries are reserved or apprehensive in officially integrating such practice into their national health care system. The problem of conducting proper evaluation was deliberately discussed and the guidelines for research methodology in the evaluation of herbal medicine were drafted in the recent WHO meeting. The guidelines that attempt to provide assistance to such research emphasise the need to recognise its long traditional usage and findings reported in literature. Thus the guidelines recommend less stringent procedure as compared to the pharmaceutical product evaluation. However it is important and necessary to include factors such as well-designed methodology quality control standardisation toxicity and safety tests of product prior to clinical trial following the Good Clinical Practice GCP. Besides the professionals of different disciplines the team of evaluators should include the traditional practitioners wherever possible. The measurement of outcome should not necessarily base on experimental testing but also include improvement parameter in relation to quality of life. The need of appropriate ethical consideration is also very important and should always be considered by the researchers. In accordance with the Malaysian GCP guidelines for clinical trial certain harmonisation is indeed required to enable more Malaysian herbal products to be evaluated in the near future.

Full text available from:

Abstract

Traditional medicine especially with the use of herbal products has recently received global attention. The World Health Organisation WHO also actively promotes the use of traditional medicine if proven scientifically safe and efficacious. However due to various factors including lack of proper documentation most of the countries are reserved or apprehensive in officially integrating such practice into their national health care system. The problem of conducting proper evaluation was deliberately discussed and the guidelines for research methodology in the evaluation of herbal medicine were drafted in the recent WHO meeting. The guidelines that attempt to provide assistance to such research emphasise the need to recognise its long traditional usage and findings reported in literature. Thus the guidelines recommend less stringent procedure as compared to the pharmaceutical product evaluation. However it is important and necessary to include factors such as well-designed methodology quality control standardisation toxicity and safety tests of product prior to clinical trial following the Good Clinical Practice GCP. Besides the professionals of different disciplines the team of evaluators should include the traditional practitioners wherever possible. The measurement of outcome should not necessarily base on experimental testing but also include improvement parameter in relation to quality of life. The need of appropriate ethical consideration is also very important and should always be considered by the researchers. In accordance with the Malaysian GCP guidelines for clinical trial certain harmonisation is indeed required to enable more Malaysian herbal products to be evaluated in the near future.

[error in script]

Item Type:	Proceedings Paper
Additional Information:	Available at Perpustakaan Sultan Abdul Samad Universiti Putra Malaysia 43400 UPM Serdang Selangor Malaysia. mal QK99 A1S471 2000 Call Number
AGROVOC Term:	RESEARCH
AGROVOC Term:	SAFETY
AGROVOC Term:	HERBACEOUS PLANTS
AGROVOC Term:	DRUG PLANTS
AGROVOC Term:	AGROINDUSTRY
AGROVOC Term:	MALAYSIA
Geographical Term:	MALAYSIA
Depositing User:	Ms. Suzila Mohamad Kasim
Last Modified:	24 Apr 2025 05:13
URI:	http://webagris.upm.edu.my/id/eprint/11222

Actions (login required)

View Item