Is GCP Refresher Training Effective – Perspective from Malaysia

The International Conference on Harmonization—Good Clinical Practice (ICH-GCP) is an international ethical and scientific quality standard that ensures the rights, safety and well-being of clinical trial subjects are protected and that the clinical trial data generated are credible1.

Malaysia GCP Guideline was developed by National Pharmaceutical Regulatory Agency (NPRA) in 1999. This guideline adopts the basic principles outlined by ICH-GCP with some modifications to adapt to local conditions2The object of the Malaysia GCP Guideline is to ensure that drug-related trials in Malaysia are conducted in accordance with international ethical and scientific standards2. Although there is currently no legislative requirement for GCP training, mechanisms were in placed to ensure that Investigators are trained on GCP. For example, it is mandatory to submit a copy of Principal Investigator’s GCP certificate when obtaining regulatory approval from NPRA to conduct a clinical trial3. In addition, all investigators must submit their GCP certificates for ethics committee’s approval in Malaysia4. Since the first edition of Malaysian GCP to the current 4th edition, approximately 12,000 clinicians have been GCP certified5.

It is recommended for GCP certified personnel to be retrained on GCP guidelines every three years in order to stay up to date with updated regulations, standards, and guidelines6. With this, Clinical Research Malaysia (CRM), a research organization founded by Malaysia Ministry of Health (MOH), has taken the initiative to conduct GCP Refresher Workshop for clinicians, nurses, allied health professionals and study coordinators who have been certified with Malaysian GCP. The objective of the workshop was to provide a review on the principles of GCP, to improve participants’ skills and knowledge on managing the conduct of a clinical trial as well as to share recommendations on how to conduct a GCP-compliant clinical trial.

Since the first workshop in 4 October 2016, CRM has conducted 31 GCP refresher workshops throughout Malaysia to approximately 450 participants at no cost. Majority of the participants are clinicians, nurses, allied health professionals from government hospitals who are involved in clinical trials. Over the course of the conduct of the workshop, modifications have been made based on participants’ feedback to improve the quality and the learning outcome of the workshop. A summary of the changes in the workshop agenda is listed in Table 1.

Table 1: Changes in presented topics from 2016 to present

As shown in Table 1, pre- and post-workshop assessment test was introduced in 16 March 2017 in order to evaluate the effectiveness of the workshop on participants’ knowledge on GCP.

In this paper, we analyzed the pre- and post-workshop assessment scores for workshops conducted since 16 March 2017.


Before the start of the workshop, participants were required to complete 20 multiple-choice GCP-related questions (pre-workshop assessment). The questionnaires were then collected before the start of the workshop. After the workshop, participants are then required to complete the same set of questions (post-workshop assessment). Participants were given 30 minutes to complete the questionnaire.

The average score of the pre- and post-assessment results from participants of the same workshop will then be calculated. This will constitute one set of data point.

The average score of pre- and post-workshop assessment from each workshop conducted since the introduction of the assessment in 16 March 2017 were compiled. Of the 28 workshops conducted since then, 5 workshops’ data could not be retrieved, hence only 23 sets of data points were analyzed.

The compiled average score of pre- and post-workshop were then compared using Microsoft Excel’s t-test assuming unequal variance to evaluate if there is any significant improvement in the average assessment score after the workshop.


Table 2 shows the compiled data from 23 workshops. 420 participants completed the pre-workshop assessment, and 434 participants completed the post-workshop assessment. There is on average, 20% improvement in the assessment score before and after the workshop.

Table 2: Compilation of the average pre- and post-workshop assessment score.

Table 3: Result of T-test assuming unequal variances comparing the pre- and post-workshop average scores.

As shown in Table 3, the p-value is less than 0.05, suggesting that there the improvement in the score is significant after participants attended the GCP Refresher Workshop.


Training of investigators and allied health professions involved in clinical trials on the regulations and standards that govern clinical trials is important to improve the quality of studies and ensure maximum safety for the study subjects. A survey amongst clinical researchers in Saudi Arabia on their ICH-GCP knowledge found that is poor understanding of investigator’s responsibilities on informed consent, and prompt reporting to the ethics committee7. Hence, refreshing investigators’ awareness of their responsibilities could help to improves the performance of investigators in conducting clinical trials particularly in these important ethical aspects.

The GCP refresher workshop conducted by CRM fulfills its objective to provide revision of the principles of GCP to participants, with more an average of 20% improvement in assessment score after the workshop.

The factors that potentially contribute to the success of the CRM GCP Refresher workshop in improving participant’s score was discussed below:

Case studies discussion

Case studies were included for “Informed Consent”, “Adverse Event Reporting” and “Protocol Deviations” for discussion. Participants were given real-life scenario case studies and they were required to answer guided questions in groups. Study have shown that case studies are more effective than textbook reading at promoting learning of key concepts and comprehension of the relevance of concepts to real life scenario8.

Interactive workshop

Several methods were used to make the workshop interactive such as games, quizzes, videos, group activities and group discussion. Active engagement of participants helps in the retain of information9.

Trainers would also actively engage participants by asking questions and encouraging participants to share their experience and practices. Regulations of clinical research can be understood more easily when participants can reflect the principles upon their own experience10.

Feedback from participants 

Participants were given evaluation form at the end of the workshop to provide their feedback and opinion of the workshop. Based on their feedback, modifications were made to improve the conduct of the workshop:

  1. Duration of workshop
    The first GCP Refresher Workshop is a half-day (4 hours) workshop. Participants reflected that the workshop felt rushed and suggested to make it a full-day course. Subsequent workshops were then conducted one full day (8 hours) to ensure participants can learn at a better pace, contributing a better learning outcome.
  2. Content of workshop
    One of the earlier feed-back received is to include more activities especially for safety reporting and protocol deviations. Modifications based on this feedback is the shift from a lecture-style workshop to activity-based workshop. Presentation slides were also revised to be more concise to retain attention.
  3. Provision of GCP booklet
    Following a feedback from participants, the current edition of the Malaysian GCP Guideline booklets were provided for participants to refer to during the workshop.


It is important for investigators and allied health professions who are involved in clinical study to be trained on the latest GCP guideline. GCP Refresher Workshop conducted by CRM is effective in refreshing participants’ knowledge on GCP guideline. The success of the workshop could be attributed to providing case studies for discussion, interactive activities as well as taking participants’ feedbacks into consideration. We would recommend other governing bodies to support the conduct of similar interactive workshops in their jurisdiction; and to take participants’ feedback for continuous improvement.

Yoong Kai Shen is the Senior Training Executive, and Joanne Yeoh is the Head of Clinical Operations, both of Clinical Research Malaysia.


  1. Good Clinical Practice Network, n.d. ICH GCP Good Clinical Practice. Retrieved 05Nov2019 from:
  2. National Pharmaceutical Regulatory Agency, 2018. Malaysian Guideline for Good Clinical Practice 4th Edition. Introduction to Malaysian Guidelines For GCP, Page 8.
  3. National Pharmaceutical Regulatory Agency, 2017. Malaysian Guideline for Application of Clinical Trial Import Licence and Clinical Trial Exemption. Retrieved 05Nov2019 from:
  4. Society Of Clinical Research Professionals Malaysia, 2016. A Guide to Conducting Clinical Trials in Malaysia, First Edition. Retrieved 05Nov2019 from:
  5. National Pharmaceutical Regulatory Agency, 2018. Malaysian Guideline for Good Clinical Practice 4th Edition. Forward to the Fourth Edition, Page 4.
  6. National Institutes of Health, n.d. Good Clinical Practice Training. Retrieved 05Nov2019 from:
  7. Al-Nomay NS, 2015. Compliance with ICH-GCP Guidelines among the Saudi Health Care Professionals: Should Saudi Arabia Conduct Widespread ICH-GCP Training? J Public Health Dev Ctries. 2015; 1(2): 75-82. Retrieved 05Nov2019 from:
  8. Bonney KM, 2015. Case study teaching method improves student performance and perceptions of learning gains. J Microbiol Biol Educ. 2015;16(1):21–28. Retrieved 05Nov2019 from:
  9. Robin L. Bachelor Patrick M. Vaughan Connie M. Wall, 2012. Exploring the Effects of Active Learning on Retaining Essential Concepts in Secondary and Junior High Classrooms. Retrieved 05Nov2019 from:
  10. Halkoaho A, Matveinen M, Leinonen V, Luoto K, Keränen T., 2013. Education of research ethics for clinical investigators with Moodle tool. BMC Med Ethics. 2013;14:53. Published 2013 Dec 12. Retrieved 05Nov2019 from:

Source : Applied Clinical Trails Online

Initiatives to Establish Capabilities in Early Phase Clinical Research in Malaysia – Applied Clinical Trials

Industry-sponsored research (ISR) has been progressively growing within Asia in the last decade. Early phase trials play a crucial role not only in drug development, but also in expanding the clinical trial ecosystem, bringing in scientific knowledge and novel medical technologies and treatments to individual countries. The benefits of conducting early phase trials also extend towards a “spill-over” effect of boosting locally conducted later phase trials leading to access of novel treatments by a large and relatively naïve patient pool and bringing in investments. With over 20 years experience in conducting late phase clinical trials, the Malaysian government realizes the positive impact of encouraging the growth of early phase clinical trials. The country also has an untapped potential that can be used toward delivering high quality early phase clinical trials such as a naïve and diverse patient pool, established and experienced infrastructure, capabilities and resources, and competitive regulatory timelines compared to its neighbouring countries. In view of this, there is a strong focus on growing the clinical trial ecosystem in the country by optimising the already existing resources while expanding and improving them to further facilitate early phase ISRs in the country. Clinical Research Malaysia (CRM) established for this purpose in 2012 and a Phase 1 Realization Project (P1RP) was launched in 2016. Supported by five pillars ranging from development of guidelines to people and capability development, the goal is to develop Malaysia to cater to early phase studies. This review describes the opportunities for growth of early phase studies in Malaysia and the initiatives taken to build a comprehensive clinical trial ecosystem to attract these trials into the country.


The conduct of industry-sponsored research (ISR) in Asia has been gaining momentum for more than a decade1-9. Frost & Sullivan’s 2017 white paper2 states that the contract research organisation (CRO) market in Asia-Pacific (APAC) is the fastest growing in the world with an expected compound annual growth rate (CAGR) of 20% (from 2016-2021) compared to an increase of 11.4% CAGR globally. This follows from estimates of clinical trial volumes increasing from 5.9% of the total global volume between 2005-2007 to 9.7% in 2011 in the APAC regionshowing a steady influx of clinical studies, as it gains a reputation for being a preferred destination for ISRs.

However, a lack of early phase trials (phase 0 and phase I trials) is evident5,6. Louisa et al.5 studied the number of ISR phase I trials between 2007–2009 found that only 6.8% of phase I trials made their way to this region. The early phase clinical trial market in 2013 was valued at approximately USD 11.9 billion with an expected CAGR of 1.5–2%reaching 4% this year3. Owing to the important roles of early phase trials that range from its scientific benefits4 to capacity building and economic advantages, most Asian countries, including Malaysia have focused initiatives into building adequate infrastructure to attract them.

Early phase trials: Asian benefits

To date (as of 12 July 2018), there are 16,248 interventional ISRs covering all phases globally, 27.2% (4,424) are early phase (phase 0 and phase I) trials10. Figures 1 and 2 show the proportion of early phase trials in Asia and Southeast Asia which are significantly smaller compared to North America and Europe.












Figure 1: Proportion of early phase ISRs in Asia, Southeast Asia, North America and Europe for the year 2018. Search criteria for these and all other values were recruiting, not yet recruiting, active–not recruiting, enrolling by invitation, interventional studies, phase 0, phase I and industry funded. Asia: North Asia, South Asia, East Asia and Southeast Asia; total number of trials in the region will defer from number of trials in an individual country due to inclusion of multicentre trials.












Figure 2: Number of early phase ISRs in Southeast Asia. Total number of ISRs registered in as of July 2018 in Asia is 5,126 (of 16,248) and total number of early phase ISRs is 943 (of 4,424). Search criteria for these and all other values were recruiting, not yet recruiting, active –not recruiting, enrolling by invitation, interventional studies, phase 0, phase I and industry funded. Asia: North Asia, South Asia, East Asia and Southeast Asia; total number of trials in the region will defer from number of trials in an individual country due to inclusion of multicentre trials.


There are several benefits in conducting early phase trials in Asia. These are for example, certain diseases which are more prevalent compared to the west wherein epidemiology, health services, social determinants, co-morbidities and genetic components of the population can have an effect on how a treatment may be used, and, differences in genetics and gastrointestinal microbiome effect on the pharmacokinetics and pharmacodynamics of drug molecules4,5. There have also been concerns that racial and ethnic minorities, women and the elderly are often underrepresented in early drug development programmes making Asia an attractive destination for clinical trials1.

Therefore, the conduct of more early phase trials in regions within Asia, like Southeast Asia, plays a pivotal role to ensure that the populations proportional to the potential uses of the product after its registration and approval are conducted from the earliest stages5.

Early phase trials: opportunities for growth in Malaysia
Diverse and accessible subject pool

Malaysia, located in Southeast Asia, is a multi-racial country consisting of Malays, Chinese, Indians and numerous indigenous people who are mostly treatment naïve. This provides the genetic diversity that is important in every clinical trial. The epidemiology of diseases in an individual country is also a crucial consideration when determining the success of a clinical trial as it signifies the availability of study subjects and mitigates the risks of poor accrual rates that can cause trials to fail at huge costs11. Though a strong presence of the disease provides for a rich source of ready patients for later phase clinical trials, it also serves as an important incentive for governments to encourage testing of novel treatments in FIH trials within the country.

Patient pool with cardiovascular risks — diabetes, hypertension and hypercholesterolemia

At a global level, the top 20 indications of industry-sponsored clinical trials, regardless of phase of study include cardiovascular disease, diabetes mellitus, hypertension and hypercholesterolemia7. Conducting early phase trials targeting these conditions would be doubly beneficial to countries like Malaysia that face major public health concerns with them. Early phase trials would allow access to novel treatments and changing standards of care and with a ready pool of relatively naïve patients, sponsors and CROs would have an easy access to subjects for later phase trials. Being part of the drug development process from its early stages allows investigators and clinical trial staff to become familiar with the treatment, thereby allowing continued progress of clinical study phases to occur more smoothly.

In Malaysia, the National Health and Morbidity Survey published in 2015 showed that prevalence of diabetes mellitus among Malaysian adults of 18 years and above was 17.5% (8.3% known and 9.2% undiagnosed)12. The overall prevalence for hypertension and hypercholesterolemia were 30.3% (13.1% known and 17.2% undiagnosed) and 47.7% (9.1% known and 38.6% undiagnosed), respectively. In 2016, disease of the circulatory system was in the top five principal causes of hospital admissions (both private and public hospitals), at 7.44% of total admissions and within the top five principal causes of mortality13. With regards to Type 2 diabetes mellitus, it has more than doubled since 1996 and coupled with a prevalence of 27–31% in overweight and obesity in school children, this disease poses a major public health concern14.

With the high prevalence of cardiovascular risk factors such as diabetes, hypertension and hypercholesterolemia, not only has Malaysia a ready, diverse and relatively naïve patient pool for later phase ISRs that fit into the top 20 clinical trial indications, but it also gives the Malaysian government a strong incentive to encourage early phase trials.

Oncology patient pool

Studies in the field of oncology treatment are currently the top indication for clinical trials. Using the following search criteria, start date 01/01/2013-31/12/2017, recruiting, not yet recruiting, active – not recruiting, enrolling by invitation, early phase I and phases I-III, indication for cancer takes up 54.5% of the total industry sponsored interventional studies [10]. Additionally, projected distributions of available new active substances in the global market by disease type from 1996–2020 show15 a projected growth in oncology biopharmaceutical and pharmaceutical products making up 13% of the total new active substances.Thirty-three percent of novel drug approvals in 2015 by the United States Food and Drug Administration (USFDA) were for oncology related products whilst 27% were approved in 201716-18. In the US alone, there were 836 drugs and vaccines for cancer in various stages of clinical development or awaiting USFDA approvals19.

In Malaysia, cancer is within the top five causes of mortality and in 2016, the total hospital admissions for neoplasms were 4.2% (based on total admissions of > 3 million)13. Breast cancer is the most common of all cancers (17.7%) followed by colorectal (13.2%) and cancer of the trachea, bronchus and lung (10.2%)20.

FIH trials of oncology drugs differ from early phase trials in other therapeutic areas as they are evaluated in patients rather than healthy volunteers. The characteristics of oncology products, mainly its safety profile, do not allow for testing in healthy volunteers. In the absence of alternative effective treatments in oncology, participation in these trials using novel compounds are considered an opportunity to these patients21.

Therefore, with the global pipeline of oncology drugs in clinical development having seen a robust growth over the past two decades22, combined with the strong presence of cancer among Malaysians, not only are sponsors presented an opportunity to tap into the available pool of cancer patients, it is also a considerable push for the Malaysian government to spur the growth of early phase oncology clinical trials within the country.

Cost effectiveness

The cost of developing a new molecular entity can be over USD 1 billion with an average estimate of USD 2.6 billion8. Added to that, the development of a new medicine from identification through approval for marketing can take up to or more than 12 years. In view of the extreme financial investments, Asian countries like Malaysia, which provide treatments and medical procedures at a lower cost than in developed countries1,9, can be seen by sponsors and CROs as an ideal site for conducting clinical trials with lower investments.

The 2017 Frost & Sullivan white paper’s1 costing estimates of conducting clinical research per patient, per visit in all therapeutic areas in all phases shows Malaysia as having the second lowest cost coming before India (USD 350 vs. USD 330) while costs in Singapore was similar to that in the USA (USD 1,210 vs.USD 1,380) and that in South Korea was USD 890.

Regulatory timelines

One of the complexities of performing clinical trials in Asia is the heterogeneous nature of the regulatory processes and timelines among the countries in the region1-3,6.

However, countries in the region have attempted to harmonise these to ensure better data acceptability and reduce trial and drug approval timelines1. Malaysia is part of the ASEAN Free Trade Area (AFTA) that undertook the ASEAN Common Technical Documents (ACTD) and ASEAN Common Technical Requirements (ACTR) initiatives to standardise drug approval processes.

In Malaysia, ethics review and regulatory approvals together with import licensing and contract negotiations occur concurrently allowing for faster processing timelines and is comparable with timelines in South Korea and Singapore (approximately 2-3 months1). In a recent report, regulatory timelines have been improved to within 30 working days23 while the centralized ethics committee under the Ministry of Health has shortened its timelines to 51 calendar days.

Established infrastructure, resources and capabilities

An established and functioning network of clinical trial centres with advanced equipment and technology; knowledgeable physicians and available key opinion leaders in different specialties also play an important role in attracting ISRs1.

Malaysia has a well-developed and equipped healthcare system manned by medical doctors that practice and comply with international clinical practice standards24. ISRs in Malaysia are conducted at government hospitals, teaching institutions, private hospitals and government health clinics. Government hospitals receive and treat the largest number of patients thus presenting a unique opportunity for access to the primary care patient pool.

Developing an ecosystem for early phase clinical research in Malaysia

The Government of Malaysia realizing the potential positive impact of early phase trials for patients, scientific advancements and economic growth is stepping up its existing clinical trial capabilities by building new initiatives to drive early phase clinical research capacity in-country and develop an attractive early phase clinical trial ecosystem.

In lieu of this, the Malaysian government included the creation of a supportive ecosystem with the establishment of Clinical Research Malaysia (CRM) a non-profit company, wholly owned by the Ministry of Health24, to equip the ecosystem of clinical research in the country25. Its goal is to reach at least 1,000 clinical trials by the year 2020. Part of the initiatives stated in this section is to set up more clinical research centres, develop more Good Clinical Practice (GCP) certified investigators and improve existing IRB and EC timelines. The Phase 1 Realization Project (P1RP) initiated by CRM in 2016 was aimed at realizing this aspiration of making sure Malaysia is capable in conducting early phase studies.

The benefits of conducting early phase trials in Malaysia as laid out by the P1RP are the increase of phase II and III trials as a result of a spillover effect from conducting more phase I trials, contribution to the transfer of knowledge and technologies to Malaysians, creation of new jobs in clinical research, spurring local innovation, prevention of investment outflow and moving the country as a whole higher up the clinical research value chain. For patients, it increases the opportunity to receive novel medications or treatment that is not yet available in the market as the majority of ISRs are interventional in nature providing treatment at no cost to patients. It also provides a means for the government to expand its healthcare resources to include more patients and medications especially oncology treatment that are costly.

The P1RP Blueprint

The P1RP stands on 5 pillars, which are the establishment of guidelines for conducting phase I clinical trials in the country, people development, capability development, preparation of sites and risk management. To date, all of the P1RP pillars have been implemented and fulfilled. In the first quarter of 2019, the country’s regulatory authority has indicated that it is ready to review FIH studies by June 2019.

The P1RP strategy is multi-pronged wherein regulatory agencies are equipped with the right knowledge to review phase I clinical trials and conforming to international standards, local experts are trained with the necessary skills to analyze early phase trials through engagement with international consultants, preparation of clinical trial unit at hospitals to conduct phase I studies, and the development of an action plan to manage and mitigate any given crisis that may occur during the clinical trial process.

Development of phase I clinical trial guidelines

The Malaysian Phase I Clinical Trial Guidelines26 was launched in November 2017. Prior to this, the country did not have a specific guideline on phase I clinical trials. The effort saw the coming together of experts and investigators in the field of clinical trials from the Ministry of Health, Ministry of Higher Education, ethics and regulatory bodies as well as industry experts. International key opinion leaders on clinical trials were also invited as subject matter experts. The guidelines were based on The Association of the British Pharmaceutical Industry (ABPI) 2012 version of phase I clinical trial guidelines27 as this document took into account and expanded its content to reflect the latest changes in conducting FIH trials. The Malaysian guidelines in turn considered local regulatory bodies and agencies’ existing procedures, and the local clinical trial environment, adapting relevant areas to facilitate the applicability of the ABPI guidelines in Malaysia.

People Development

To gain knowledge and experience in phase I clinical trials so as to implement and impart these to relevant agency officers, three regulatory officers were sent to pursue their postgraduate studies at The Christie, Manchester, as well as King’s College London, under a collaborative scholarship between CRM and the Public Service Department. This will allow them to work within a leading phase I clinical trial unit and gain experience and understanding in the designing and delivering of phase I studies. This attachment is important as these regulatory officers will be the ones responsible in reviewing the dossiers of phase I studies in Malaysia.

The Ministry of Health has also planned to send local investigators to be attached at reputable phase I centres, including the Princess Margaret Cancer Center, to be exposed to the experience in conducting FIH studies.

The government has also started initiatives to bring back Malaysians from overseas. Experts or specialists from higher-income countries coming back would have an edge due to a global mindset. Coupled with an in-depth knowledge of the country, people and the culture, it creates a world-class pool of specialists that can support early phase trials2.

Initiatives to develop and perform centralized professional training for study coordinators to complement the work of investigators have also began. To attract more specialists to participate in clinical trials, the Ministry of Health now allows for 20% of a work-week (or one full day off) for investigators to focus solely on research.

Capability development

In a 2011 report presentation of the Health Committee at the 49th Parliament sitting in New Zealand28, some of the recommendations put forward to increase New Zealand’s presence in the clinical trial industry were, to establish a strong intra-governmental collaboration between different ministries, ensure a culture that values research within the public health system and requiring the Standing Committee on Therapeutic Trials to carry out all scientific reviews within 30 calendar days.

As part of the capability development pillar of P1RP, a Scientific Review Panel (SRP) for FIH clinical trials was established to support the Medical Research and Ethics Committee (MREC), a centralized ethics committee, in performing scientific evaluations of FIH trials undertaken by and/or conducted in clinical trial sites in Malaysia. The scope of review includes all FIH studies on new chemical, biological and biosimilar drugs not registered in Malaysia.

The intensity of early phase clinical trials is more time-consuming requiring more physical exams, vital signs monitoring, electrocardiogram (ECG) monitoring and pharmacokinetic laboratory tests compared to later phase trials29. The P1RP project and initiatives will harness the available resources and capabilities available within the country’s health system as well as increase its knowledge with international collaborations to ensure that the country is ready to meet with the demands of early phase trials.

Preparation of sites

Sarawak General Hospital located in a major city in East Malaysia is targeted to be fully equipped to handle early phase clinical trials. It also serves as a template for future units to be developed in other hospitals. This hospital is already a major medical centre with a ready access to large patient populations and the clinical trial centre is well-equipped and operated by well-trained scientific and medical staff.

Risk management

In June 2007, the “Guideline on Strategies to Identify and Mitigate Risks for First-in-Human Clinical Trials with Investigational Medicinal Products” was finalised by the EMA30. The scope of the guidance encompasses both biologics and new chemical entities and, was recently updated in 2016 (EMA/CHMP/SWP/28367/07)31and places the focus on the pharmacological characteristics of a new drug.

The document was created to support the transition from non-clinical to the early phase of clinical development and identifies influencing risk factors of a product, includes consideration of quality aspects, testing strategies, designs for FIH studies and mitigation strategies such as initial dosing calculation and dose escalation30.

Therefore, part of the P1RP initiative is the preparation and training of risk management guidelines and to manage any crisis in relation to early phase clinical trials. These include creation of a standard operation procedure (SOP) to prepare for and manage all types of crises requiring immediate attention during early phase trials (i.e. unexpected side effects from a clinical trial). The SOP is designed to also ensure that all actions are coordinated, timely, accurate, consistent and effective in minimising the potential for confusion, rumor and misinformation. The overall objective of this effort is to offer support to the organisation and processes of early phase trials in difficult situations and to the greatest possible extent, limit potential injury to patients, consumers or the reputation of the institutions.


CRM initiated the ACCELERATE project to move the nation’s focus further upstream to early phase drug discovery and development, utilising readily available resources in the country. The project involves converging expertise and collaborations across agencies, clinical research industries and universities on pre-clinical projects. Through this initiative, CRM has intensified collaborations with various universities and research institutes in ‘bench to bedside’ projects. The conversion of pre-clinical studies into early and late phase trials may spur discovery, local innovation and eventually manufacturing of innovator drugs in Malaysia. Additionally, it can prevent outflow of investments and move the country higher up the clinical research value chain.


Malaysia’s effort through the P1RP and ACCELRATE project underlines the government’s commitment to bring the country into a new phase in the clinical trial industry. In the local context, early phase clinical trials play a key role in enhancing the capability of the country in the development of medical science and treatment of disease as well as placing Malaysia at the cutting edge of research. To this end, the Malaysian government’s goal is to develop the country into becoming the preferred destination for industry-sponsored research.


AJA Ooi is the Business Development Manager; KF Khalid is the Former Head of Business Development, both for Clinical Research Malaysia.


  1. Frost & Sullivan (2016) Asia: preferred destination for clinical trials.
  2. Frost & Sullivan (2017) The changing face of global clinical trials: Asia-Pacific as an ideal destination for specialty biopharma.
  3. Ilancheran M, Pritchard JF (2015) Is South Korea the next emerging early phase destination? Appl Clin Trials Jan 29.
  4. Kapiriri L, Lavery J, Singer P, Mshinda H, Babiuk L, et al (2011) The case of conducting first-in-human (phase 0 and phase I) clinical trials in low and middle income countries. BMC Public Health 11:811.
  5. Louisa M, Takeuchi M, Setiabudy R, Nafrialdi, Takeuchi M (2012) Current status of phase I clinical trials in Asia: an academic perspectives. Acta Med Indones 44(1):71-7.
  6. Rahman S, Majumder M (2012) Managing clinical trials in Asia: issues, threats, opportunities and approaches. South East Asia j public health (online) 2(2):80-4.
  7. Yathindranath S, Kureishi A, Singh S, Yeow S, Geng G, et al (2014) Evolution of the clinical trial landscape in Asia Pacific. Open access j clin trials 6:75-84.
  8. Mohs R, Greig N (2017) Drug discovery and development: role of basic biological research. Alzheimers Dement (N Y) 3:651-7.
  9. Murthy S, Mandl K, Bourgeois F (2015) Industry-sponsored clinical research outside high-income countries: an empirical analysis of registered clinical trials from 2006-2013. Health Res Policy Syst 13(28).
  10. Clinical
  11. Baer A, Bridges K, O’Dwyer M, Ostroff J, Yasko J (2010) Clinical research site infrastructure and efficiency. J Oncol Pract. 6(5):249-52.
  12. Ministry of Health Malaysia (2015) National Health & Morbidity Survey: Non-communicable disease, risk factors and other health problems.
  13. Ministry of Health Malaysia (2017) Health facts.
  14. Tee E, Yap R (2017) Type 2 diabetes mellitus in Malaysia: current trends and risk factors. Eur J Clin Nutr 71(7):844-9.
  15. Projected distribution of global available new active substances by disease type between 1996 and 2020.
  16. U.S. Food and Drug Administration. Novel drug approvals for 2015.
  17. U.S. Food and Drug Administration. Novel drug approvals for 2017.
  18. Buffery D (2016) Innovation tops current trends in the 2016 oncology drug piepline. Am Health Drug Benefits 9(4):233-8.
  19. National Cancer Institute, Ministry of Health Malaysia (2016) Malaysian national cancer registry report 2007-2011.
  20. Salzberg M (2012) First-in-human phase I studies in oncology: the new challenge for investigative sites. Rambam Maimonides Med J 3(2):e0007.
  21. Pharmaceutical Research and Manufacturers of America. Medicines in development 2015 report: medicine in development for cancer.
  22. IQVIA (2017) Lifetime trends in biopharmaceutical innovation: recent evidence and implications.
  23. Regulatory timelines in the Asia-Pacific.
  24. Ooi AJA, Khalid KF (2017) Malaysia’s clinical research ecosystem. Appl Clin Trials. Jan 26.                     
  25. National Key Economic Areas (2016) Healthcare NKEA fact sheet.
  26. Clinical Research Malaysia (2017) Malaysian phase I clinical trial guidelines.
  27. Association of British Pharmaceutical Industry (2012) Guidelines for phase 1 clinical trials.
  28. Health Committee (2011) Inquiry into improving New Zealand’s environment to support innovation through clinical trials.
  29. Craft B, Kurzrock R, Lei X, Herbst R, Lippman S, et al (2009) The changing face of phase I cancer clinical trials: new challenges in study requirements. Cancer 115(8):1592-7.
  30. Milton M, Horvath C (2009) The EMEA guideline on first-in-human clinical trials and its impact on pharmaceutical development. Toxicol Pathol 37:363-71.                                     
  31. European Medicines Agency (2016) Guideline on strategies to identify and mitigate risks for first-in-human and early clinical trials with investigational medicinal products.

Source : Applied Clinical Trails Online

Recruitment is everything in a trial!

By Soon Wen Xian, a medical graduate from Volgograd State Medical University, a Clinical Research Associate at an international pharmaceutical organization based in Singapore.

There are many stages in a clinical trial, for example: feasibility study, start up, active recruitment stage, maintenance stage and study closure. Each stage of a trial is important, but the recruitment process is undeniably the most important part. Because if there is no patient being recruited, there will be no data to analyse and without data, the trial will not meet any objectives. That is why recruitment process plays a very important role in ensuring a successful clinical trial. Recruitment rate is almost always the main issue in a trial. If we can speed up the recruitment rate, not only would we have the results faster, we would also be able to reduce the cost of the trial. In order to make recruitment process a successful one, both site member and sponsor must know their roles well. For this issue, I would like to share how we can make a trial recruitment process easier, faster, and more effective. Read more

Hospital Miri

  • Miri Hospital is a Secondary Hospital providing services in the north zone of the state of Sarawak.
  • The services provided are in terms of patient care to the community.
  • Miri Hospital is located about 2.5km from Miri city centre and covers an area of 87.11 acres.
  • It began operations on May 6 1995, officially opened by Chief Minister Of Sarawak Tan Sri Pehin Datuk Patinggi (Dr) Haji Abdul Taib Bin Mahmud on 30 August 1996.

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Research Personality: Dato’ Dr Fam Tem Lom

Dato’ Dr. Fam Tem Lom was born and raised in a small town in Sarawak called Kampung Beratok. His father is a smallholder planting pepper plants and rubber trees. Dato’ Dr. Fam is the 9thof 15 siblings and they live in a simple house with earthen floor where he shared a room with four of his siblings until he left for university.

In those days, he and his siblings wake up early to help tap rubber and tend to pepper plants and then helps out again after school and completing their homework.

Having graduated from UNIMAS in 2002, Dato’ Dr. Fam went on to serve as a Houseman and then as Medical Officer and Clinical Specialist at Sarawak General Hospital from 2002 until 2010. He obtained the MRCPI in 2007 and FRCPI and FRCP (Glasgow) in 2015. It was in 2010 that he got posted to Miri General Hospital where he stayed until today.

In 2016, Dato’ Dr. Fam was bestowed the DIMP by his Royal Highness SultanHaji Ahmad Shah Al-Musta’in Billah ibni Almarhum Sultan Abu Bakar Ri’ayatuddin Al-Mu’adzam Shahwhich carry the title Dato’. He is married to Datin Dr. Doreen Chan Chu Ching and has three children. Read more

A Unique Model to Accelerate Industry-sponsored Research in Malaysia – Journal for Clinical Studies

This article originally appeared in Volume 11, Issue 1 of the Journal for Clinical Studes.

The influx of industry-sponsored research (ISR) into the Asia Pacific region is continually growing due to the rising costs and complicated processes involved in drug development. Several countries within the region such as Singapore and, more notably, South Korea, have taken the initiative to develop and further strengthen their place as preferred destinations to conduct clinical trials. One such initiative is the establishment of specific entities that focus on nurturing and expanding the existing clinical trial ecosystem within the individual countries. With over 20 years of experience in conducting late-phase trials, the Malaysian government is no exception.

In the last six years, Malaysia has been steadily building a comprehensive and supportive clinical research ecosystem within the country. This includes the creation of Clinical Research Malaysia (CRM), a non-profit company wholly owned by the Ministry of Health (MOH).1 This review will present CRM as a unique business model, established to create a thriving and comprehensive ecosystem for ISRs in Malaysia and how this business model may be relevant and replicated in Asian countries that are looking to focus on attracting ISRs. Read more

Mainstreaming May Improve Access to Ovarian Cancer Genetic Testing in Malaysia

By Ms. Yoon Sook Yee, Cancer Research Malaysia

Mainstreaming may improve access to ovarian cancer genetic testing inMalaysia and help identify mutation carriers who may benefit from risk management and targeted treatment, suggests preliminary results of the MaGiC Study presented at the ESMO Asia 2018 Congress.

“Screening for BRCA1 and BRCA2 mutations is recommended for all patients with non-mucinous ovarian cancer,” said lead author Ms Sook-Yee Yoon, Genetic Counsellor, Cancer Research Malaysia, Subang Jaya, Malaysia. “Genetic testing identifies mutation carriers and triggers appropriate risk management and treatment. In Malaysia BRCA genetic testing and counselling is only available at specialised centres in Kuala Lumpur but most people live outside the capital.” Read more

Hepatitis C Elimination Through Access to Diagnostics (Head-Start) Comes to Malaysia!

Q&A with Sonjelle Shilton, Project Manager for the HCV Programme


Sonjelle Shilton, Project Manager for the HCV Programme

I joined FIND in 2017, and took on the role of Project Manager for the Hepatitis C Elimination through Access to Diagnostics (HEAD-Start) project earlier this year. The majority of my career has been in Africa, where I spent 10 years as the Director of Operations of a community-based health outreach organization, HardtHaven, in rural Ghana – which showed me how critical it is that public health interventions be collaboratively designed and implemented with rigorous and meaningful data capture. If you don’t measure it, you can’t see if it’s making an impact. I brought my experiences from Ghana to the monitoring and evaluation team at Gavi, the Vaccine Alliance, where I coordinated multi-country, multi-year, prospective full-country evaluations before joining FIND. I hold a Master of Global Public Health and the Global WACh Graduate Certificate in Integrated Health of Women, Adolescents and Children from the University of Washington, USA.

Can you tell us a little more about FIND? Why are diagnostics so important?

FIND is a global non-profit organization that drives innovation in the development and delivery of diagnostics to combat major diseases affecting the world’s poorest populations. It is astounding to see how often diagnostics do not exist, are inaccessible, or cost too much. This needs to change: not only do diagnostics tell patients what is wrong with them, they allow patients to be linked to the right treatment. Plus they are essential to a fully functional health system for many reasons, including surveillance to detect disease patterns and inform public health decisions. Diagnostics also play an important role in the research and development of drugs and vaccines. Read more

Hospital Raja Perempuan Zainab II

Hospital Kota Bharu was established in the 1920s. In remembrance of the late Sultanah Kelantan, this tertiary care facility name was changed to Hospital Raja Perempuan Zainab II (HRPZII) and the ceremony was officiated by Kebawah Duli Yang Maha Mulia Al-Sultan Kelantan Tuanku Ismail Petra Ibni Almarhum Sultan Yahya Petra on 5 September 2005.  HRPZII is the main referral centre for the entire state of Kelantan and Northern District of  Terengganu. The undergraduate medical students from University Sains Malaysia (USM) and Post Graduate Distance Learning Program (PJJ) doctors use HRPZII for their practical training, as well as trainees preparing for examination conducted by Universiti Kebangsaan Malaysia (UKM), USM and professional bodies overseas. Basic and post basic training for paramedical personnel and are conducted as in-service training for all categories of staff. In addition, HRPZII was recently appointed as a Regional Hub for Telemedicine, Regional Referral Centre for Psychiatry service and Regional Clinical Research Centre (CRC). Read more

Journey to success in Phase 1b Clinical Study for Hepatitis B at the University Malaya Medical Centre, Malaysia

By Chan Wei Quan, Site Manager, Global Clinical Operations (GCO) Malaysia, Janssen

Prof Rosmawati and her team, together with CIC and Janssen representatives.

If you were diagnosed with chronic hepatitis B, would you be willing to try an experimental compound developed by a world-renowned pharmaceutical company? On one hand, you may be hesitant but on the other, you may want to know more about it. For novel compounds to be approved for use in the market, pharmaceutical companies go through a period of pre-clinical and clinical phases to evaluate the compound’s effectiveness. To achieve this, volunteers are needed! Read more