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Fulltext Investigator-initiated clinical trials in Malaysia and the role of the Clinical Research Centre of the Ministry of Health

Sivanandam AF, Hon YK, Yuen S, Muninathan P, Goh PP, Lim TO

Med J Malaysia, 2010 Jun;65 Suppl A:138-42.
PMID: 21488475

The objective of this review is to better understand the concept of investigator-initiated trials and its benefits. While investigator-initiated trials can be an invaluable tool, there are several challenges in its initiation and management. However, it is for these reasons that Clinical Research Centre (CRC) had developed the Investigator Initiated Trial (IIT) Programme where financial support and technical assistance are provided to local investigators embarking on their own clinical trials. In the course of preparing the review, we found that the inclination of investigator-initiated trials has yet to be well established in Ministry of Health, Malaysia. Given the potential and impact of such trials, clinicians should be aware of their ability as well as the availability of a supportive network in mobilising their concerted research efforts. Greater research collaboration among investigators could foster more innovative, insightful and constructive research.

Matched MeSH terms: Government Agencies*
Biosimilars in Malaysia: Regulatory Framework, Approved Products, and Adverse Effects

Mohd Sani N, Aziz Z, Kamarulzaman A

Ther Innov Regul Sci, 2021 05;55(3):490-502.
PMID: 33231863 DOI: 10.1007/s43441-020-00243-y

INTRODUCTION: Biosimilars are a cost-effective alternative to original biologic medicines that allow patients access to biologic therapies for various chronic diseases. Our paper aims to provide an overview of biosimilars in Malaysia with emphasis on the comparison of Malaysian guidelines with guidelines from well-established regulatory agencies, a review of biosimilars' market approval and their reported adverse effects (AEs) as well as clinical trials conducted in Malaysia.
METHODS: We searched the official websites of the National Pharmaceutical Regulatory Agency (NPRA) Malaysia and three other well-established agencies, online databases of Medline® and EMBASE for guidelines on legislation and regulations of biosimilars. Meanwhile, we extracted the reports of AEs involving biosimilars in Malaysia from the NPRA database and for global AEs from the World Health Organisation VigyLize database. The ClinicalTrials.gov Website by the U.S. National Library of Medicines was the source for data on clinical trials.
RESULTS: Malaysia followed the principles of the European Medicines Agency biosimilar regulations and issued their guideline in 2008. Since then, NPRA has approved 24 biosimilar products and recorded 499 AE reports, of which 43 (8.6%) were serious. NPRA has also approved ten Phase III clinical trials in Malaysia with four trials still ongoing.
CONCLUSION: Malaysia follows a stringent regulatory pathway for the approval of biosimilars enacted by well-established regulatory agencies to maintain the quality, efficacy and safety of biosimilars. Introducing biosimilars to the Malaysian market would improve patients' accessibility to biologic therapies.

Matched MeSH terms: Government Agencies
Fulltext [Current status and problem of occupational health and safety of occupational diving workers in Malaysia]

Morimatsu Y, Nishikiori H, Okahara Y, Kojima Y, Kinoshita S, Mori M, et al.

Sangyo Eiseigaku Zasshi, 2020 07 25;62(4):165-167.
PMID: 31983700 DOI: 10.1539/sangyoeisei.2019-021-W
Matched MeSH terms: Government Agencies
Fulltext An Evaluation of Malaysian Regulatory Process for New Active Substances Approved in 2017 Using the OpERA Methodology

Sani NM, McAuslane N, Kasbon SH, Ahmad R, Yusof FAM, Patel P

Ther Innov Regul Sci, 2020 Sep;54(5):1215-1224.
PMID: 32865804 DOI: 10.1007/s43441-020-00140-4

INTRODUCTION: The National Pharmaceutical Regulatory Agency (NPRA) embarked on a regulatory-strengthening program and is evaluating its processes. Optimising Efficiencies in Regulatory Agencies (OpERA) is a regulatory-strengthening program that provides benchmarking data that can define performance targets and focus performance improvement. The objective of this study was to use OpERA methodology to determine where time is spent in the NPRA approval process and to form a baseline to measure the performance improvements.
METHODS: The OpERA tool was used to collect specific milestone data that identify time periods, review stages, and data points for new active substances and biosimilars approved by NPRA in 2017.
RESULTS: In 2017, 25 new active substances and 1 biosimilar were approved by NPRA in a median of 515 days, representing both agency and applicant time. The median time between dossier receipt and the initiation of NPRA scientific assessment was 135 days, but there was a wide variation in queuing time. The median total assessment time was 279 days (agency and applicant timing). NPRA took a median of 166 days; applicants took a median of 131 days to respond to deficiency questions, with up to 6 cycles of review required for approval and 65% of applications requiring 4-5 cycles to provide satisfactory responses.
CONCLUSIONS: As a result of these data, NPRA proposes three improvements: target start for scientific assessment 100 days after file acceptance, a maximum of 5 review cycles, and applicant response time limited to 6 months. These results will serve as a baseline for further assessment.

Matched MeSH terms: Government Agencies
Fulltext Factors influencing open government data post-adoption in the public sector: The perspective of data providers

Mustapa MN, Hamid S, Md Nasaruddin FH

PLoS One, 2022;17(11):e0276860.
PMID: 36322601 DOI: 10.1371/journal.pone.0276860

Providing access to non-confidential government data to the public is one of the initiatives adopted by many governments today to embrace government transparency practices. The initiative of publishing non-confidential government data for the public to use and re-use without restrictions is known as Open Government Data (OGD). Nevertheless, after several years after its inception, the direction of OGD implementation remains uncertain. The extant literature on OGD adoption concentrates primarily on identifying factors influencing adoption decisions. Yet, studies on the underlying factors influencing OGD after the adoption phase are scarce. Based on these issues, this study investigated the post-adoption of OGD in the public sector, particularly the data provider agencies. The OGD post-adoption framework is crafted by anchoring the Technology-Organization-Environment (TOE) framework and the innovation adoption process theory. The data was collected from 266 government agencies in the Malaysian public sector. This study employed the partial least square-structural equation modeling as the statistical technique for factor analysis. The results indicate that two factors from the organizational context (top management support, organizational culture) and two from the technological context (complexity, relative advantage) have a significant contribution to the post-adoption of OGD in the public sector. The contribution of this study is threefold: theoretical, conceptual, and practical. This study contributed theoretically by introducing the post-adoption framework of OGD that comprises the acceptance, routinization, and infusion stages. As the majority of OGD adoption studies conclude their analysis at the adoption (decisions) phase, this study gives novel insight to extend the analysis into unexplored territory, specifically the post-adoption phase. Conceptually, this study presents two new factors in the environmental context to be explored in the OGD adoption study, namely, the data demand and incentives. The fact that data providers are not influenced by data requests from the agency's external environment and incentive offerings is something that needs further investigation. In practicality, the findings of this study are anticipated to assist policymakers in strategizing for long-term OGD implementation from the data provider's perspective. This effort is crucial to ensure that the OGD initiatives will be incorporated into the public sector's service thrust and become one of the digital government services provided to the citizen.

Matched MeSH terms: Government Agencies
Governing agricultural progress: a genealogy of the politics of pest control in Malaysia

Triantafillou P

Comp Stud Soc Hist, 2001;43(1):193-221.
PMID: 17941160
Matched MeSH terms: Government Agencies/economics; Government Agencies/history; Government Agencies/legislation & jurisprudence
Fulltext Car lease swap business: its mechanism and owner’s choice in Malaysia

NOORIHA ABDULLAH, MOHD FAIZOL RIZAL MOHD RASID, NURHAFIZAH NORMAN@ZAKARIA

Malaysian Journal of Qualitative Research, 2019;5(1):41-49.
MyJurnal

This paper describes the Malaysian car owners’ preference to purchase their car through car lease swap arrangement. Since owning a car nowadays is a necessity for most individuals, people will try to find the easiest and fastest way to own a car. Hence, the aim of this paper is to describe the issues of car lease swap businesses conducted in Malaysia, in particular to understand the reasons, business mechanism, and benefits of buying a car via this method. Due to limited empirical studies on car lease swap arrangement in Malaysia, the research adopted a qualitative approach, which utilises the snowball method to identify its participants. Interviews were conducted with relevant parties, who were directly involved in car lease swap business, which include the car lease dealers, the car owners and third parties (buyers). The findings indicate that the car lease dealers were the most to gain out of this business, meanwhile the car owners were worse off. Compared to the third parties, the car owners benefited from the convenient arrangement of the business. Nevertheless, due to its vague legality, it is possible to have negative implications on all parties involved. As such, future research should look at all parties involved in investigating the issues of this car lease swap business, such as relevant government agencies and all other stakeholders.

Matched MeSH terms: Government Agencies
Evaluation performance of time series approach for forecasting air pollution index in Johor, Malaysia

Nur Haizum Abd Rahman, Muhammad Hisyam Lee, Suhartono, Mohd Talib Latif

Sains Malaysiana, 2016;45:1625-1633.

The air pollution index (API) has been recognized as one of the important air quality indicators used to record the
correlation between air pollution and human health. The API information can help government agencies, policy makers
and individuals to prepare precautionary measures in order to eliminate the impact of air pollution episodes. This study
aimed to verify the monthly API trends at three different stations in Malaysia; industrial, residential and sub-urban areas.
The data collected between the year 2000 and 2009 was analyzed based on time series forecasting. Both classical and
modern methods namely seasonal autoregressive integrated moving average (SARIMA) and fuzzy time series (FTS) were
employed. The model developed was scrutinized by means of statistical performance of root mean square error (RMSE).
The results showed a good performance of SARIMA in two urban stations with 16% and 19.6% which was more satisfactory
compared to FTS; however, FTS performed better in suburban station with 25.9% which was more pleasing compared
to SARIMA methods. This result proved that classical method is compatible with the advanced forecasting techniques in
providing better forecasting accuracy. Both classical and modern methods have the ability to investigate and forecast
the API trends in which can be considered as an effective decision-making process in air quality policy.

Matched MeSH terms: Government Agencies
Seeking representation in policy-making governmental bodies

Abu Bakar S

Malays J Pathol, 1997 Dec;19(2):93-7.
PMID: 10879247
Matched MeSH terms: Government Agencies/legislation & jurisprudence; Government Agencies/trends*
Patient and procedure selection for bariatric and metabolic surgery in Malaysia- The Malaysian Consensus

Gafoor AM, Reynu R, Kirubakaran M, Vimal Kumar V, Nik Ritza NM, Tikfun G, et al.

Med J Malaysia, 2021 03;76(2):229-232.
PMID: 33742633

The rise in obesity has fuelled the current debate of its classification as a disease. Contrary to just being a medical condition or a risk factor for other diseases, obesity is a complex disease with multifaceted aetiology as well as its own disabling capacities, pathophysiology, and comorbidities. The problem of obesity in Malaysia is serious and calls for active intervention by all stakeholders ranging from government agencies to insurers and healthcare providers. To aid efforts to curb obesity, this consensus statement for bariatric surgery provides a basis for inclusion and exclusion criteria as well as the types of procedures accepted as the norm in Malaysia. This consensus statement was initiated by the Society of Endoscopic and Laparoscopic Surgeons of Malaysia and was collaborated with representatives from the Ministry of Health Malaysia.

Matched MeSH terms: Government Agencies
Fulltext Employee career decision making: the influence of salary and benefits, work environment and job security

Nur`ain Achim, Nur Idayu Badrolhisam, Nurfitriah Zulkipli

Journal of Academia Universiti Teknologi MARA Negeri Sembilan, 2019;7(101):41-50.
MyJurnal

Every individual at some point will make critical career decision making in life. Making a wrong career decision will affect a person’s fu ture including feeling unhappy, job stress and eventually job withdrawal. This study examined the factors affecting career decision making among government servants in Malaysia. The population and sample were taken from three departments. The population wa s 140 employees and 103 respondents were identified as the sample. Convenience sampling was employed to collect the primary data. The result from several statistical analysis found that all the independent variables; salary and benefits, working environmen t and job security were correlated with the dependent variable that is career decision making. Therefore, from the findings, employers, especially from the government agencies, were urged to increase recruiting permanent position instead of contract employ ment and offering better benefits to improve employees’ career decision making.

Matched MeSH terms: Government Agencies
Fulltext Investment literacy, social influence and undergraduates' readiness to invest: dataset from Malaysia

Halim ZA, Zolkefli MN, Kusairi S, Nor SM, Zawawi NHM, Sukemi MN

Data Brief, 2021 Feb;34:106700.
PMID: 33490327 DOI: 10.1016/j.dib.2020.106700

Since the launch of the InvestSmart™ initiative in 2014, the government agencies in Malaysia have been actively engaging community and university students via their outreach programs to promote investment literacy. Given this background, the state of the investment literacy of Malaysian undergraduates and their readiness to invest is intriguing. Therefore, this article offers a dataset of Malaysian undergraduates' readiness to invest and the role that investment literacy and social influence play in their readiness to invest. Using a non-probability sampling technique, 500 undergraduate students in Malaysia were engaged to participate voluntarily in this survey. Descriptive statistics are presented in this paper. The dataset provides insights into the current state of investment literacy among Malaysian undergraduates, the sources of information on stock investment, and the readiness of these undergraduates to participate in the stock market.

Matched MeSH terms: Government Agencies
Fulltext Using mathematics to quantify subjective decisions: application of analytic hierarchy process to risk assessment

Rabihah Md. Sum

Journal of Advanced Research Design, 2018;44(1):7-19.
MyJurnal

Risk management requires human judgements, from risk identification, assessment to response. Although automated tools are useful in handling large amounts of data and in performing complex calculations rapidly, humans undertake the entire risk management process. They bring to the process their intuitions, insights, previous experiences and skills. Therefore, creating a rich source of information of risks faced by an organisation. Ignoring human factors may impoverish information and limit risk management to only measurable factors. This study contributes to the field of decision-making and risk assessment by investigating and discussing in detail how to quantify subjective judgements using the Analytic Hierarchy Process (AHP). AHP is used to assess risk of an insurance company. It discusses how to do risk assessment by combining both intuition and analytic in the decision-making process. The study defines intuition as knowledge and experience, and analytic as the mathematics or quantitative analysis to derive the result. It demonstrates how Analytic Hierarchy Process (AHP) - a flexible multi-attribute or multi-criteria decision making tool, enables risk managers to use both intuition and analytic to do risk assessment. Risk assessment using AHP produces global priority weights representing the overall risk ranking of an insurance company. The study develops a risk assessment problem and uses AHP to organise and structure risks and sub-risks of the problem. It uses formative evaluation method with open-ended questionnaires to obtain feedbacks from risk managers on AHP. Three employees of a risk management department in a government agency assesses the risks using AHP. AHP strengths are easy to use and understand, improves risk assessment and useful for risk assessment problems that have scarce or no data. AHP limitation are the numbers and repetitiveness of the pairwise comparisons. The participants either ignore some of the pairwise questions or they answer randomly instead of deliberate judgements.

Matched MeSH terms: Government Agencies
Fulltext A qualitative study of governance of evolving response to non-communicable diseases in low-and middle- income countries: current status, risks and options

Rani M, Nusrat S, Hawken LH

BMC Public Health, 2012;12:877.
PMID: 23067232 DOI: 10.1186/1471-2458-12-877

Segmented service delivery with consequent inefficiencies in health systems was one of the main concerns raised during scaling up of disease-specific programs in the last two decades. The organized response to NCD is in infancy in most LMICs with little evidence on how the response is evolving in terms of institutional arrangements and policy development processes.

Matched MeSH terms: Government Agencies/organization & administration
Deworming/family planning project launched on estate

Siva V

Asian Pac Popul Programme News, 1979;8(1):24-5.
PMID: 12309491

PIP: A deworming/family planning project funded by JOICFP was successfully initiated in Kerling Estate, Kuala Kubu Bahru, Malaysia. Rapport between estate management, workers, and the National Family Planning Board helped establish the project. A recent Gotong-Royong or community self-help project had encouraged enthusiasm among workers to clean up the estate. Mothers were exhorted to plan their families and devote attention to the health and welfare of the children. The need for parents to understand the causes of infestation and educate their children to wear slippers or shoes and develop good toilet habits was emphasized by Dr. Nor Laily Aziz. Continuing National Family Planning Board and Government support was pledged.

Matched MeSH terms: Government Agencies*
Fulltext Health-care data collecting, sharing, and using in Thailand, China mainland, South Korea, Taiwan, Japan, and Malaysia

Aljunid SM, Srithamrongsawat S, Chen W, Bae SJ, Pwu RF, Ikeda S, et al.

Value Health, 2012 2 1;15(1 Suppl):S132-8.
PMID: 22265060 DOI: 10.1016/j.jval.2011.11.004

This article sought to describe the health-care data situation in six selected economies in the Asia-Pacific region. Authors from Thailand, China mainland, South Korea, Taiwan, Japan, and Malaysia present their analyses in three parts. The first part of the article describes the data-collection process and the sources of data. The second part of the article presents issues around policies of data sharing with the stakeholders. The third and final part of the article focuses on the extent of health-care data use for policy reform in these different economies. Even though these economies differ in their economic structure and population size, they share some similarities on issues related to health-care data. There are two main institutions that collect and manage the health-care data in these economies. In Thailand, China mainland, Taiwan, and Malaysia, the Ministry of Health is responsible through its various agencies for collecting and managing the health-care data. On the other hand, health insurance is the main institution that collects and stores health-care data in South Korea and Japan. In all economies, sharing of and access to data is an issue. The reasons for limited access to some data are privacy protection, fragmented health-care system, poor quality of routinely collected data, unclear policies and procedures to access the data, and control on the freedom on publication. The primary objective of collecting health-care data in these economies is to aid the policymakers and researchers in policy decision making as well as create an awareness on health-care issues for the general public. The usage of data in monitoring the performance of the heath system is still in the process of development. In conclusion, for the region under discussion, health-care data collection is under the responsibility of the Ministry of Health and health insurance agencies. Data are collected from health-care providers mainly from the public sector. Routinely collected data are supplemented by national surveys. Accessibility to the data is a major issue in most of the economies under discussion. Accurate health-care data are required mainly to support policy making and evidence-based decisions.

Matched MeSH terms: Government Agencies/organization & administration*
Fulltext Biosimilars in Developed and Developing East and Southeast Asian Countries: Japan, South Korea, and Malaysia-Overview, Evolution, and Regulations Assessment

Bas TG, Oliu Castillo C

Biomed Res Int, 2016;2016:5910403.
PMID: 27213153 DOI: 10.1155/2016/5910403

The development of biological products has experienced continuous growth over the past three decades. The expiration of patent protection for many biological medicines has led to the development of biosimilars in many countries around the world. This paper reviews the literature on biosimilar drugs and covers their therapeutic status, clinical trials, approved biosimilars, and regulatory guidelines in Japan, South Korea, and Malaysia. The literature suggests that biosimilars are comparable but not identical to the reference product. They are not a generic version of an innovative product and do not ensure therapeutic equivalence. Biosimilars present more challenges than conventional generics and their marketing approval is also much more complicated. Guidelines for biosimilars were published in Japan in July 2009 by the Ministry of Health, Labour and Welfare (MHLW), in South Korea in March 2009 by the Ministry of Food and Drug Safety (MFDS), and in Malaysia in July 2008 by the National Pharmaceutical Control Bureau (NPCB).

Matched MeSH terms: Government Agencies/legislation & jurisprudence*
Insights into public export promotion programs in an emerging economy: the case of Malaysian SMEs

Ayob AH, Freixanet J

Eval Program Plann, 2014 Oct;46:38-46.
PMID: 24907593 DOI: 10.1016/j.evalprogplan.2014.05.005

This study evaluates the impact of public export promotion programs (EPPs) among small and medium-sized enterprises (SMEs) in Malaysia. Three indicators, level of awareness, frequency of use, and perception of usefulness, were examined according to a firm's export status. The global evaluation suggests that exporters are more frequent users of EPPs and perceive them to be more useful than non-exporters. Nonetheless, both groups demonstrate higher levels of awareness, are frequent users, and perceive the programs relating to export info/knowledge are more usefulness than programs relating to financial assistance. Further analysis also reveals that the frequency of use and the perception of usefulness for most programs are positively related to export experience, but not to export turnover. This study offers insights into the effectiveness of export programs for encouraging export initiation and expansion in an emerging economy.

Matched MeSH terms: Government Agencies
Long lead time drought forecasting using lagged climate variables and a stacked long short-term memory model

Dikshit A, Pradhan B, Alamri AM

Sci Total Environ, 2021 Feb 10;755(Pt 2):142638.
PMID: 33049536 DOI: 10.1016/j.scitotenv.2020.142638

Drought forecasting with a long lead time is essential for early warning systems and risk management strategies. The use of machine learning algorithms has been proven to be beneficial in forecasting droughts. However, forecasting at long lead times remains a challenge due to the effects of climate change and the complexities involved in drought assessment. The rise of deep learning techniques can solve this issue, and the present work aims to use a stacked long short-term memory (LSTM) architecture to forecast a commonly used drought measure, namely, the Standard Precipitation Evaporation Index. The model was then applied to the New South Wales region of Australia, with hydrometeorological and climatic variables as predictors. The multivariate interpolated grid of the Climatic Research Unit was used to compute the index at monthly scales, with meteorological variables as predictors. The architecture was trained using data from the period of 1901-2000 and tested on data from the period of 2001-2018. The results were then forecasted at lead times ranging from 1 month to 12 months. The forecasted results were analysed in terms of drought characteristics, such as drought intensity, drought onset, spatial extent and number of drought months, to elucidate how these characteristics improve the understanding of drought forecasting. The drought intensity forecasting capability of the model used two statistical metrics, namely, the coefficient of determination (R2) and root-mean-square error. The variation in the number of drought months was examined using the threat score technique. The results of this study showed that the stacked LSTM model can forecast effectively at short-term and long-term lead times. Such findings will be essential for government agencies and can be further tested to understand the forecasting capability of the presented architecture at shorter temporal scales, which can range from days to weeks.

Matched MeSH terms: Government Agencies
Fulltext Prioritizing Factors Affecting Deceased Organ Donation in Malaysia: Is a New Organ Donation System Required?

Naghavi N, Mubarik MS, Rasiah R, Sharif Nia H

Int J Gen Med, 2020;13:641-651.
PMID: 32982381 DOI: 10.2147/IJGM.S253372

Purpose: The gap between the demand and the supply of human organs for transplantation is on the rise in Malaysia, despite the efforts of governments to promote donor registration. Factors affecting willingness to donate are contextual and vary from country to country. This research mainly focuses on the selection of most suitable organ donation system through factors affecting willingness to donate in Malaysia. The objectives of this study are to prioritize those factors acting as the pillars of the organ donation system and further to select the most suitable organ donation system for Malaysia.
Patients and Methods: The data were collected from 35 experts by using a bipolar questionnaire. The study applied an analytical hierarchal process (AHP) for prioritization factors contributing to willingness to donate and then selection of a suitable organ donation system based on prioritized factors.
Results: Based on the AHP results, it is evident that donation perception (0.36) has the highest priority in influencing organ donation rates, followed by socioeconomic status (0.32), demographic factors (0.23), and financial incentives (0.09). Further, our results challenge the existing opt-in donation system in Malaysia and present a presumptive approach as a suitable system for increasing deceased donation rate in Malaysia. Presumptive approach promotes the role of health-care professionals in securing the family consent.
Conclusion: This approach is a person-oriented rather than process-oriented strategy and it relies on designated requesters' skills to evoke altruism among bereaved families. Based on results, the authors recommended that relevant government agencies focus on training nurses to discuss donation with bereaved families and raising public awareness.

Matched MeSH terms: Government Agencies

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