Trial In Malaysia Research Articles

Impact of prerelease methadone on mortality among people with HIV and opioid use disorder after prison release: results from a randomized and participant choice open-label trial in Malaysia

IntroductionMortality is elevated after prison release and may be higher in people with HIV and opioid use disorder (OUD). Maintenance with opioid agonist therapy (OAT) like methadone or buprenorphine reduces mortality in people with OUD and may confer benefits to people with OUD and HIV leaving prison. Survival benefits of OAT, however, have not been evaluated prospectively in people with OUD and HIV leaving prison.MethodsThis study prospectively evaluated mortality after prison release and whether methadone initiated before release increased survival after release in a sample of men with HIV and OUD (n = 291). We linked national death records to data from a controlled trial of prerelease methadone initiation conducted from 2010 to 2014 with men with HIV and OUD imprisoned in Malaysia. Vital statistics were collected through 2015. Allocation to prerelease methadone was by randomization (n = 64) and participant choice (n = 246). Cox proportional hazards models were used to estimate treatment effects of prerelease methadone on postrelease survival.ResultsOverall, 62 deaths occurred over 872.5 person-years (PY) of postrelease follow-up, a crude mortality rate of 71.1 deaths per 1000 PY (95% confidence interval [CI] 54.5–89.4). Most deaths were of infectious etiology, mostly related to HIV. In a modified intention-to-treat analysis, the impact of prerelease methadone on postrelease mortality was consistent with a null effect in unadjusted (hazard ratio [HR] 1.3, 95% CI 0.6–3.1) and covariate-adjusted (HR 1.2, 95% CI 0.5–2.8) models. Predictors of mortality were educational level (HR 1.4, 95% CI 1.0–1.8), pre-incarceration alcohol use (HR 2.0, 95% CI 1.1–3.9), and lower CD4+ T-lymphocyte count (HR 0.8 per 100-cell/mL increase, 95% CI 0.7–1.0).ConclusionsPostrelease mortality in this sample of men with HIV and OUD was extraordinarily high, and most deaths were likely of infectious etiology. No effect of prerelease methadone on postrelease mortality was observed, which may be due to study limitations or an epidemiological context in which inadequately treated HIV, and not inadequately treated OUD, is the main cause of death after prison release.Trial registration: NCT02396979. Retrospectively registered 24/03/2015

Early phase oncology clinical trials in Malaysia: current status and future perspectives.

Historically, the majority of oncology clinical trials are conducted in Western Europe and North America. Globalization of drug development has resulted in sponsors shifting their focus to the Asia-Pacific region. In Malaysia, implementation of various government policies to promote clinical trials has been initiated over a decade ago and includes the establishment of Clinical Research Malaysia, which functions as a facilitator and enabler of industry-sponsored clinical trials on a nationwide basis. Although oncology clinical trials in Malaysia have seen promising growth, there are still only a limited number of early phase oncology studies being conducted. Hence, the Phase 1 Realization Project was initiated to develop Malaysia's early phase clinical trial capabilities. In addition, the adaptation of good practices from other countries contribute to the effective implementation of existing initiatives to drive progress in the development of early phase drug development set up in Malaysia. Furthermore, holistic approaches with emphasis in training and education, infrastructure capacities, strategic alliances, reinforcement of upstream activities in the value chain of drug development, enhanced patient advocacy, coupled with continued commitment from policy makers are imperative in nurturing a resilient clinical research ecosystem in Malaysia.

The Amount of Folic Acid in Weekly Iron-Folic Acid Supplements Should Be Increased From 0.4 to 2,8 mg to Reduce Neural Tube Defects (NTD)

ObjectivesWeekly iron–folic acid (IFA) supplements are recommended for all menstruating women in countries where anaemia prevalence is > 20%. Anaemia caused by folate deficiency is low worldwide, and the need to include folic acid is in question. Including folic acid might reduce the risk of a neural tube defect (NTD) should a woman become pregnant. Most weekly supplements contain 0.4 mg folic acid; however, WHO recommends 2.8 mg because it is seven times the daily dose effective in reducing NTDs. There is a reluctance to switch to supplements containing 2.8 mg of folic acid because of a lack of evidence that this dose would prevent NTDs. Our aim was to investigate the effect of two doses of folic acid, compared with placebo, on red blood cell (RBC) folate, a biomarker of NTD risk. MethodsWe conducted a three-arm double-blind efficacy trial in Malaysia. Non-pregnant women (n = 331) were randomized to receive 60 mg iron and either 0, 0.4, or 2.8 mg folic acid once weekly for 16 weeks. ResultsAt 16 weeks, women receiving 0.4 mg and 2.8 mg folic acid per week had a higher mean RBC folate than those receiving 0 mg (mean difference (95% CI) 84 (54 to 113) and 355 (316 to 394) nmol/L, respectively). Women receiving 2.8 mg folic acid had a mean RBC folate 271 (234 to 309) nmol/L greater mean RBC folate than those receiving 0.4 mg. Moreover, women in the 2.8 mg group were seven times (RR 7.3, 95% CI 3.9 to 13.7) more likely to achieve an RBC folate > 748 nmol/L, a concentration associated with a low risk of NTD, compared with the 0.4 mg group. ConclusionsIFA supplements containing 2.8 mg folic acid increases RBC folate more than those containing 0.4 mg. Increased availability and access to the 2.8 mg formulation is needed. Funding SourcesNutrition International (Ottawa, Ontario).

Learning from the process evaluation of a complex, pre-conception randomised controlled trial in Malaysia: the Jom Mama project

Background Seen from a life-course perspective, pre-conception interventions are essential to reduce transmission to the next generation of obesity as a risk factor for later non-communicable diseases. The Malaysian Jom Mama project investigated the effectiveness of a combined behaviour change communication and e-health intervention in young married couples prior to first pregnancy. This paper reports on the extensive process evaluation (PE) that accompanied the Jom Mama trial. Methods In accordance with the realistic evaluation approach, a programme theory was developed for the Jom Mama project, based on key functions selected for six PE sub-studies, namely: recruitment; attrition; behaviour change communication (BCC); e-health (the Jom app); peer-support for community health promoters (CHPs); and contextual factors. The results of the first four sub-studies are reported here. Three cycles of data collection were conducted based on triangulation and a mixed-methods approach. Results The findings permitted distinguishing between theory and implementation challenges in interpreting the outcome of the Jom Mama trial.1 Recruitment and attrition proved to be challenges, and although the PE allowed Jom Mama investigators to improve procedures in order to achieve a sufficient sample size, it also has implications for engaging this age group in future pre-conception interventions. PE sub-studies showed that there were challenges in applying the BCC, and that the uptake of the Jom app varied. In one way this can be seen as an indication of limited fidelity, but it also leads to questions about how best to change the communication culture within the Malaysian health care system. Conclusions The Jom Mama PE highlighted the challenges of recruiting newly-wed couples for a pre-conception intervention. Despite thorough intervention development preparations, the PE revealed the difficulty of lifestyle behaviour change through Malaysian community health wokers who were trained on new communication strategies combined with e-health solutions, and that six intervention sessions of eight months do not constitute a sufficient dose to affect change. <div style=“page-break-after: always;”></div>

Development and Testing of a Community-Based Intervention to Address Intimate Partner Violence among Rohingya and Syrian Refugees: A Social Norms-Based Mental Health-Integrated Approach.

Intimate partner violence (IPV) is the leading form of gender-based violence globally and increases during times of conflict and displacement. To reduce IPV and encourage help-seeking, a two-phase community-based intervention was co-designed with Rohingya in Malaysia and Syrians in Lebanon. Three day workshops, utilizing a social norms-based mental health-integrated approach, were implemented for women and men in each country (n = 148). Pre- to post-measures indicated reductions in beliefs about acceptability of violence and rigid gender norms, and improvements in mental health, functioning, coping, and self-efficacy for women and men following workshop participation. Workshop participation was also associated with increased help-seeking intent, for both mental health and IPV (victims and perpetrators). Workshops included community design of poster campaigns to address IPV, which were then tested in each setting using a randomized controlled trial in Malaysia (n = 240) and a matched cluster comparison in Lebanon (n = 260). Women in both settings found IPV less acceptable in the poster condition. Help-seeking preferences were also influenced by the poster for women and men in both countries. This participatory intervention research can provide a roadmap for use in other settings, emphasizing the value of community-generated solutions to IPV among displaced populations.

The Inclusion of Folic Acid in Weekly Iron-Folic Acid Supplements Confers no Additional Benefit on Anemia Reduction in Nonpregnant Women: A Randomized Controlled Trial in Malaysia.

Weekly iron-folic acid (IFA) supplements are recommended for all menstruating women in countries where anemia prevalence is ≥20%; however, it is unknown whether the inclusion of folic acid in weekly IFA supplements reduces anemia. We examined whether the inclusion of folic acid in weekly IFA supplements conferred any benefit on hemoglobin (Hb) concentration, anemia reduction, or iron status [ferritin and soluble transferrin receptor (sTfR)], over iron alone. In this secondary analysis of a randomized controlled trial in Malaysia, n=311 nonpregnant women (18-45 y old) received 60mg Fe with either 0, 0.4, or 2.8mg folic acid once-weekly for 16 wk. Fasting blood was collected at baseline and 16 wk. A generalized linear model (normal distribution with identity link) was used to assess Hb concentration at 16 wk (primary outcome). At baseline, 84% of women had low folate status (plasma folate<14nmol/L). At 16 wk, marginal mean (95% CI) Hb was 131 (130, 133), 131 (129, 132), and 132 (130, 133) g/L; ferritin was 58.2 (53.9, 62.5), 56.5 (52.2, 60.9), and 58.0 (53.7, 62.3) μg/L; and sTfR was 5.8 (5.5, 6.1), 5.8 (5.5, 6.1), and 5.9 (5.6, 6.2) mg/L in the 0, 0.4, and 2.8mg/wk groups, respectively, with no differences between groups (P>0.05). Baseline plasma folate concentration did not modify the effect of treatment on Hb concentration at 16 wk. Among all women, the risks of anemia [risk ratio (RR): 0.65; 95% CI: 0.45, 0.96; P=0.03] and iron deficiency based on ferritin (RR: 0.30; 95% CI: 0.20, 0.44; P<0.001) were lower at 16 wk than at baseline. Despite the low folate status among these nonpregnant Malaysian women, the inclusion of folic acid in weekly IFA supplements did not reduce anemia or improve iron status, over iron alone. However, the benefits of folic acid for neural tube defect prevention still warrant its retention in weekly IFA supplements.This trial was registered at www.anzctr.org.au as ACTRN12619000818134.

A proposal for a legally enforceable no-fault compensation framework for clinical trial-related injury in Malaysia

ABSTRACT Clinical trials play a critical role in the development of life-enhancing and life-sustaining biomedical advances. It is costly and, regardless of how well-designed and ethically conducted, there are always inherent uncertainties which subsequently expose human participants to the risk of injuries or even death. In Malaysia, compensation for clinical trial-related injury has not been incorporated into standard national regulations or policies. Therefore, when clinical trial-related injuries do occur, such participants cannot be compensated by researchers, and with the absence of specific statutory laws governing trial-related injury within the local legal framework, aggrieved parties need to seek legal redress and can only depend on the existing tort laws. To propose a viable compensation framework, the existing compensation regulations and policies implemented in India and South Africa are analyzed, and their best principles have been recommended. This study proposes the implementation of a no-fault compensation framework in Malaysia which should be disbursed efficiently at minimum administrative cost. This proposed approach should be mandated by the amendment of current laws governing biomedical research and, in the interim, should be adopted voluntarily by research sponsors, institutions and investigators conducting clinical trials in Malaysia.

Efficacy and Safety of Ravidasvir Plus Sofosbuvir in Chronic Hepatitis C Infected Subjects Without Cirrhosis or with Compensated Cirrhosis: Interim Analysis Results of a Two-Stage, Open-Label, Multicentre, Phase 2/3 Trial

Background: In low- and middle-income countries, affordable direct-acting antivirals are urgently needed to treat hepatitis C virus (HCV) infection. The combination of ravidasvir, a pangenotypic NS5A inhibitor, and sofosbuvir has shown efficacy and safety in chronically HCV infected patients with genotype (GT) 4. The STORM-C-1 trial aims to assess the efficacy and safety of sofosbuvir plus ravidasvir in a more diverse population of adults chronically infected with HCV. Methods: STORM-C-1 is a two-stage, open-label, multicentre clinical trial in Malaysia and Thailand. HCV infected subjects with compensated cirrhosis (Metavir F4 and Child-Turcotte-Pugh class A) or without cirrhosis (Metavir F0-F3) were eligible to participate, regardless of HCV genotype, HIV infection status, prior interferon-based HCV treatment or source of HCV infection. Stage 1 results are reported here. Once-daily ravidasvir (200mg) and sofosbuvir (400mg) were prescribed for 12 (without cirrhosis) or 24 (with cirrhosis) weeks. The primary endpoint was sustained virologic response at 12 weeks post-treatment (SVR12). This trial is registered with ClinicalTrials.gov: NCT02961426 and the National Medical Research Register of Malaysia NMRR-16-747-29183. Findings: Between October 2016 and June 2017, 301 subjects were enrolled and 300 included in the full analysis set: 97 with GT1a, 27 GT1b, 2 GT2, 158 GT3, and 16 GT6; 81 (27%) had compensated cirrhosis; 90 (30%) had HIV co-infection; and 99 (33%) had prior interferon-based treatment. 291/300 subjects (97%, 95% CI 94%-99%) achieved SVR12. Three subjects prematurely discontinued study treatment due to adverse events. There were no deaths or treatment discontinuations due to the study drugs. Interpretation: In this first stage, ravidasvir plus sofosbuvir was found to be highly effective and well tolerated in all subgroups of this diverse adult population chronically infected with HCV. Trial Registration Number: This trial is registered with ClinicalTrials.gov: NCT02961426 and the National Medical Research Register of Malaysia NMRR-16-747-29183. Funding: Drugs for Neglected Diseases initiative; National Science and Technology Development Agency, Thailand; Department of Disease Control, Ministry of Public Health, Thailand; Ministry of Health, Malaysia. Conflict of Interest: Dr. Avihingsanon reports grants from National Science and Technology Development Agency (NSTDA) during the conduct of the study, and also from ViiV Healthcare outside of thesubmitted work. Tim Cressey and Nicolas Salvadori report a service agreement with DNDi.Isabelle Andrieux-Meyer, Caroline Menetrey, Francois Simon, Jean-Michel Piedagnel,Sasikala Siva, Alistair Swanson, Francois Bompart, Vishal Goyal, and Bernard Pecoul are employed by the Drugs for Neglected Diseases initiative. All other authors do not report any potential conflicts of interest. Ethical Approval: The initial protocol and all protocol amendments were reviewed and approved before implementation by the applicable individual institutional or national ethics committees. All subjects provided written informed consent.

Weekly iron–folic acid supplements containing 2.8 mg folic acid are associated with a lower risk of neural tube defects than the current practice of 0.4 mg: a randomised controlled trial in Malaysia

IntroductionWeekly iron–folic acid (IFA) supplements are recommended for all menstruating women in countries where anaemia prevalence is >20%. Anaemia caused by folate deficiency is low worldwide, and the need to...

Biosimilars in Malaysia: Regulatory Framework, Approved Products, and Adverse Effects.

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. 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. 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. 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.

Assessment of Glycemic Control Protocol (STAR) Through Compliance Analysis Amongst Malaysian ICU Patients.

PurposeThis paper presents an assessment of an automated and personalized stochastic targeted (STAR) glycemic control protocol compliance in Malaysian intensive care unit (ICU) patients to ensure an optimized usage.Patients and MethodsSTAR proposes 1–3 hours treatment based on individual insulin sensitivity variation and history of blood glucose, insulin, and nutrition. A total of 136 patients recorded data from STAR pilot trial in Malaysia (2017–quarter of 2019*) were used in the study to identify the gap between chosen administered insulin and nutrition intervention as recommended by STAR, and the real intervention performed.ResultsThe results show the percentage of insulin compliance increased from 2017 to first quarter of 2019* and fluctuated in feed administrations. Overall compliance amounted to 98.8% and 97.7% for administered insulin and feed, respectively. There was higher average of 17 blood glucose measurements per day than in other centres that have been using STAR, but longer intervals were selected when recommended. Control safety and performance were similar for all periods showing no obvious correlation to compliance.ConclusionThe results indicate that STAR, an automated model-based protocol is positively accepted among the Malaysian ICU clinicians to automate glycemic control and the usage can be extended to other hospitals already. Performance could be improved with several propositions.

Effectiveness of a Health Education Program to Improve Knowledge and Attitude Towards Cervical Cancer and Pap Smear: A Controlled Community Trial in Malaysia.

Objective:We examined the effectiveness of a health education program to improve; knowledge and attitude towards cervical cancer and Pap smear, and uptake of Pap smear test among female entrepreneurs in Kedah, a northern state of Malaysia. Methods:This controlled community trial involved 210 women from the districts of Alor Setar and Sungai Petani. Simple random sampling was applied to select 105 women from each district. Self-administered questionnaires were used to obtain information about the variables of interest. Health education intervention program included educational talk, demo video, experience sharing, pamphlet distribution, and text message reminders. Evaluation of outcomes was performed twice. The text message reminders acted as the cues to action that were sent between the two evaluation times at one-month interval. Women in the control group received educational talk alone. In the control group, evaluation of outcomes was done only once, which was one month after the educational talk. Results:Knowledge on cervical cancer and Pap smear, and attitude towards Pap smear among women in both intervention and control group improved significantly at Evaluation 1. However, no further improvements were observed in the intervention group at Evaluation. The uptake of Pap smear in the intervention group increased significantly from 48.0% at Baseline to 68.0% at Evaluation 1 (P<0.001), and from 68.0% to 79.0% at Evaluation (P<0.001). A significant increase in Pap smear uptake was also seen in the control group from 63.0% at Baseline to 76.0% at Evaluation stage 1 (P=0.003). Conclusions: Educational talk alone was effective in improving knowledge on cervical cancer and Pap smear, attitude towards the test, and the actual uptake of the test. However, text reminders were more effective than having an educational talk alone in increasing uptake of Pap smear test among participants.

Effect of once weekly folic acid supplementation on erythrocyte folate concentrations in women to determine potential to prevent neural tube defects: a randomised controlled dose-finding trial in Malaysia

IntroductionFolic acid (0.4 mg) taken prior to and during early pregnancy reduces the risk of neural tube defects (NTDs). Because these birth defects occur early in pregnancy, before women may...

Clinical Research and Trial Infrastructure in South-East Asia (Malaysia)

Abstract Malaysia is situated in the South East Asia region with population of 32.5milion. We comprises of multiple ethnicity with the Malay (68.6%), Chinese (23.4%), Indian (7%) and others (1%). The total number of death in 2016 were 154,000 with 74% deaths from non-communicable disease and cancer contributed to 16% of total death cases. The 10 most common cancer in Malaysia are breast cancers, followed by colorectal, lungs, lymphomas, nasopharynx, leukaemia, cervix uteri, liver, ovary and stomach. The top 5 most common cancers in male are colorectal cancers followed by lungs, prostate, nasopharynx and liver. The top 5 mos common cancers in female are breast cancers followed by colorectal, cervix uteri, lungs and ovary. There are huge opportunity to conduct clinical trials in Malaysia with over 100 clinical trial sites in Malaysia. Average cost per patient per visit is USD350. We are also partnering with multiple clinical research organization - Cancer Research Malaysia, IQVIA, Parexel and so many more. The clinical trial infrastructure in Malaysia is non-inferior comparing to developed countries with adequate number of patients. The lecture will discuss further in the clinical trial set-up in Malaysia.

THE RELATIONSHIP BETWEEN STRUCTURAL AND CLINICAL CHANGES IN SEATED COMBINED EXTENSION-COMPRESSION AND TRANSVERSE LOAD (ECTL) TRACTION IN INCREASING CERVICAL LORDOSIS: A RANDOMISED CONTROLLED TRIAL

Purpose: The aim was to assess for any relationships in changes between improved cervical lordosis and clinical outcomes of neck pain and disability. Methods: Single center, randomized controlled trial in Malaysia, to compare seated combined extension-compression and transverse load (ECTL) traction combined with exercises, to the same exercises. Participants with a reduced lordosis of less than [Formula: see text] were randomly assigned into groups, and underwent 40 treatments over 14 weeks. Pre and post lateral radiographs were reviewed by a blinded musculoskeletal radiologist for changes in cervical lordosis. VAS and Neck Disability Index (NDI) scores were used to assess clinical outcomes. Correlations between changes in curve and changes in pain and disability were assessed. Non-parametric analyses were performed on all who completed ([Formula: see text]). Results: No significant correlations between changes in lordosis and pain and disability were seen, with rho less than 0.33 and 0.24, respectively. Pain scores improved significantly in both treatment and control groups ([Formula: see text]). Disability scores also showed significant decrease in both treatment ([Formula: see text]) and control ([Formula: see text]) groups, despite a non-significant reduction in lordosis. Conclusions: Improvement in neck pain and disability did not require an improvement in lordosis. Abnormal sagittal cervical alignment therefore, is perhaps not the sole underlying cause for clinical outcomes, and a number of other psychosocial factors when considering management options.

Pilot study on functional performance and acceptability of two new synthetic adhesive male condoms (Wondaleaf): a randomized cross-over trial

ObjectivesThis study compared the condom failure rate, safety and acceptability of two new synthetic adhesive male condoms, Wondaleaf-Cap® (WLC) and Wondaleaf-On-Man® (WLM), with a marketed latex external condom Durex®-Together (DT). Study designWe enrolled healthy married, monogamous, heterosexual condom users in a randomized controlled, cross-over, pilot trial in Malaysia. We randomized participants to six groups with different condom use-orders of the experimental WLC and WLM and control latex condom for four episodes for vaginal sex over 1 month for each condom type. We summarized the clinical and non-clinical failure rate, safety and acceptability of each condom type using descriptive statistics. We tested differences in condom failure and acceptability using generalized estimating equations and repeated measure ANOVA respectively. ResultsWe screened 75 couples and randomized 50 eligible couples. Two couples withdrew before receiving any condom. The remaining used 576 condoms with 192 uses for each condom variant. Clinical failure rates of WLC, WLM and DT were 1.04%, 0% and 0.52%, respectively. Non-clinical failure rates of WLC, WLM and DT were 2.08%, 3.12% and 1.04%, respectively. Removal was found more painful with Wondaleaf products than the DT. Preferences of participants for WLC, WLM and DT were 33.3%, 29.2% and 25%, respectively. Overall, WLC and DT had greater acceptances among male participants than WLM. ConclusionResults of this pilot study support that use of synthetic adhesive male condoms is associated with failure rates similar to those seen with existing latex, and with greater acceptability. A larger study to ascertain non-inferiority is underway. ImplicationsThe availability of synthetic adhesive male condoms may increase the acceptability of condom use. However, removal pain and clinical performance requires further study.

Addressing procedural challenges of ethical review system: Towards a better ethical quality of clinical trials review in Malaysia

ABSTRACTThe review of clinical trials with human participants in Malaysia is governed by a decentralized control system. The clinical trial protocols are reviewed by 13 registered research ethics committees (RECs) in Malaysia. A governmental body, the National Pharmaceutical Control Bureau, is responsible for the inspection and oversight of these registered RECs to ensure that they comply with the regulatory requirements. However, this study highlights that each REC in Malaysia has a different standard operating procedure and ethical review process. Other procedural challenges identified include inadequate membership, poor mechanism for research monitoring after ethical approval, and insufficient resources. Establishments of a national standard of REC and a central ethics committee are suggested to ensure procedural compliance in the oversight of clinical trials in Malaysia. While there is a growing concern that procedural compliance may not have a direct impact on the protection of human subjects, our key point is that an ethical review system compliant with the national standards could serve as a strong framework to support and enhance the ethical quality of decision-making and judgement. We believe that being aware of how influential procedural compliance can be would help committees improve the ethical quality of their research review.

Public-Private Partnership in Oncology: An Approach to Address Shortage of Oncologists in Clinical Trials in Malaysia

Globally, the pipeline of oncology drugs in clinical development has seen a robust growth over the past decade. Oncology clinical trials remain the top 3 industry-sponsored trials in Malaysia for the last five years. To be successful in the development of new cancer therapies, sponsors and contract research organizations (CROs) need access to sufficient numbers of trained and interested investigators, besides highly trained staff and resources to offer those trials to patients. Unfortunately, in Malaysia, the number of oncologists stands between 105 and 110. About half of all oncologists are GCP certified, and from this, even a lesser number are found active in industry-sponsored research (ISR). A public–private partnership in oncology was initiated by the Ministry of Health, Malaysia, to address the shortage of oncologists at the public sector where most oncologists are saturated with clinical work and unable to take up oncology trials. At the same time, despite the majority of oncologists working in the private sector, their willingness to conduct clinical trials are hampered by difficulties in access to patients due to the fact that the pool of cancer patients is mostly concentrated in public hospitals. This paper describes the development and implementation of a public–private partnership in oncology to address the lack of uptake of industry-sponsored oncology clinical trials in the country by allowing oncologist from the private sector to tap into the patient pool of public hospitals. As part of this policy, a pilot project was initiated at three public hospitals to allow clinical specialists (e.g., hematologists, surgeons, gynae-oncologists) to collaborate with oncologists from the private sector in industry sponsored research.

Error and exaggeration in the presentation of the significance of a DNA match in criminal trials in Malaysia

DNA evidence is now widely used in criminal trials across jurisdictions, including Malaysia. One important issue to be considered is how the significance of a DNA match that uses statistical calculations should be presented and explained in a criminal trial. This article demonstrates how the presentation of the significance of a DNA match in criminal trials in Malaysia has been tainted with error, exaggeration and bias towards the prosecution case based on the reference to case law. It also provides recommendations in order to ensure that the significance of a DNA match is properly presented in the criminal trials in Malaysia.

新型含硅型沸石肥料对水稻采收质量和产量的效益

水稻为全球最重要的粮食作物，中国也为全球最大的消费国和生产国。本研究测试一种新型含硅的水稻专用配方，分别于马来西亚和台湾地区测试水稻产量和质量。在马来西亚的方面，用量从化学肥料的用量从每公顷810公斤减至本肥料的150公斤，传统化肥产量为6100公斤/公顷。使用绿丰肥料每公顷收成可高达8000公斤。增产幅度33%。台湾方面，在屏东的九如乡和崁顶乡使用绿丰®水稻肥的增幅分别达到16.7%和15.7%。分析去壳后糙米质量，脱壳后千粒重，绿丰®水稻肥处理者较传统复合肥高出5.2%~7.8%。总淀粉含量方面，绿丰®水稻肥比对照组高出6.5%，稻谷水分和矿物质各处理间差异不大。说明了对比大幅减量的绿丰®水稻肥所生产出来的稻米质量，在水分和灰分的表现和传统肥料者无大差异，在总淀粉含量更高，直接说明了水稻对此肥料的利用率更佳，此配方适用于热带和亚热带水稻环境，十分合宜于中国境内水稻区推广使用。 Paddy rice is the most important staple food in the world. China is the biggest producer and consumer of paddy in the world as well. In this study, novel silica-containing fertilizers for paddy were used to study the yield and quality of paddy in Malaysia and Chinese Taipei. Compared to conventional chemical fertilizers, trial in Malaysia showed that the recommendation usage of this fertilizer was greatly reduced from 810 kg conventional to 150 kg; the yield was found increased from 6100 kg/ha to 8000 kg/ha, with 33% increment. In the trial in Taiwan, the yields from Jiuru and Kanting, Pingtung County also reported to be 16.7% and 15.7% increment, respectively. Evaluation on the quality of dehusked paddy, performance on thousand-grain weight, water content, ash and total starch, thousand-grain weight increased 5.2% - 7.8%; total starch content has 6.5% higher than conventional fertilizer group. No difference observed on the water content and mineral contents of both treatments. This further explained that qualities of grains were not affected by the reduction of fertilizer. This novel silica-containing fertilizer was especially suitable for tropical and sub-tropical paddy areas and very promising to be further promoted in China paddy plantation.