MyMedR

Fulltext Trial Sequential Analysis in Critical Care Medicine: The Way Forward

Lew CCH, Lee ZY, Gluud C

Crit Care Med, 2022 Dec 01;50(12):e809-e810.

PMID: 36394406 DOI: 10.1097/CCM.0000000000005634

Matched MeSH terms: Clinical Trials as Topic*

Do variations in allocation concealment methods influence the effects found in intervention reviews?

Naing C, Hasan SS, Aung K

J Evid Based Med, 2011 Nov;4(4):255-8.

PMID: 23672756 DOI: 10.1111/j.1756-5391.2011.01156.x

(i) To explore any discrepancies in intervention effects between a set of Cochrane reviews that includes trials with liberal criteria and a set with restrictive criteria in which trials with liberal design have been removed from the review, and (ii) to suggest ways to improve the quality of evidence.

Matched MeSH terms: Clinical Trials as Topic/methods*; Clinical Trials as Topic/standards*

Fulltext Descriptive review of safety, reactogenicity and immunogenicity of dengue vaccine clinical trials, 2003 - 2013

Jelitha R, Nirmalatiban P, Nyanamalar S, Cabriz MG

Med J Malaysia, 2015 Apr;70(2):67-75.

PMID: 26162380

Dengue vaccine development has been one of the strategies to reduce dengue incidence in the world alongside with other horizontal interventions such as vector control and the transgenic mosquito programmes. The objective of this paper is to evaluate the safety, reactogenicity and immunogenicity of dengue vaccine clinical trials for the last ten years systematically through a descriptive review. This paper discusses safety issues like adverse events, systemic adverse reactions, injection site reactions, viraemia, morbidity and mortality as well as immunogenicity which measures effectiveness through mean geometric titre and seropositive rates. Adverse events were seen to range from 0% to 28.3%. Immunogenicity was noted to increase post 1st and 2nd dose and decrease post 3rd dose. The seropositivity at baseline ranged between 53.1% and 97.8% at post 3rd dose, and it was 88.5% for at least four serotypes. The dengue vaccine studies that were reviewed were shown to be relatively safe with low reactogenicity, however the immunogenicity was unequal and waning. The immunogenicity waned post 3rd dose showing a decrease in all serotypes of varying degrees although the seropositivity, on average, at post 3rd dose was 97.8%. It can be concluded that dengue vaccine development would require further studies on its unequal and waning immunogenicity, which could result in a more severe form of dengue following wild infection, during re-immunisation, especially if there is variation in the circulating virus.

Matched MeSH terms: Clinical Trials as Topic

Fulltext Clinical Trials and Biomedical Research

Citation:
MMC Guideline 009/2006: Clinical Trials and Biomedical Research. Kuala Lumpur: Malaysian Medical Council; 2006

Matched MeSH terms: Clinical Trials as Topic

Fulltext The National Medical Research Register--a vital link between current and future research

Lim TO, Asmaliza SI, Goh PP, Michael AJ, Hon YK, Thandapani R, et al.

Med J Malaysia, 2010 Jun;65 Suppl A:124-7.

PMID: 21488472

Registration of research proposal to a publicly accessible website with searchable function allows information sharing and ensures research transparency. The National Institutes of Health Malaysia, realising the importance of research registration, established the National Medical Research Register (NMRR) in 2007. The NMRR functions more than just a local register: it also links to ethics approval and MOH medical research grant application. It thus facilitates researchers in their application to the Ministry of Health Research and Ethics Committee (MREC) and for Ministry of Health research grant. In addition, MREC committee members can review research protocol on NMRR website, thus saving much time and resources. From May 2007 till December 2009, more than 3000 people have registered as NMRR public users and more than 1000 research proposals have been uploaded in NMRR. The number of registration of research proposals, clinical trials and industrial sponsored trials steadily increased from year 2007 to year 2009. The web-based NMRR is the first research register in the world that links research proposal registration to ethical review and research grant application. Its future plan is to be linked with publication. Therefore, it is indeed an innovation that Malaysians should be proud of.

Matched MeSH terms: Clinical Trials as Topic*

Fulltext Good clinical practice: issues and challenges

Merican MI

Med J Malaysia, 2000 Jun;55(2):159-63.

PMID: 19839142

Matched MeSH terms: Clinical Trials as Topic/standards*; Clinical Trials as Topic/ethics

Fulltext Patient registries in Malaysia and the role of the Clinical Research Centre of the Ministry of Health

Pillay MS, Noor Hisham A, Zaki Morad MZ, Lim TO, Jamaiyah H, Jaya Purany SP

Med J Malaysia, 2008 Sep;63 Suppl C:1-4.

PMID: 19227669

Matched MeSH terms: Clinical Trials as Topic*

Fulltext Patient registries supplement. Foreword

Abdul Hamid M

Med J Malaysia, 2008 Sep;63 Suppl C:vii.

PMID: 19227668

Matched MeSH terms: Clinical Trials as Topic*

Fulltext Psychological stress and treatment--research issues

Azhar MZ

Med J Malaysia, 2004 Jun;59(2):143-5.

PMID: 15559161

Matched MeSH terms: Clinical Trials as Topic*

Good clinical practice

Merican I

Med J Malaysia, 2000 Aug;55 Suppl B:35-7.

PMID: 11125519

Matched MeSH terms: Clinical Trials as Topic/methods

Fulltext The Future of Clinical Trial Design in Oncology

Spreafico A, Hansen AR, Abdul Razak AR, Bedard PL, Siu LL

Cancer Discov, 2021 Apr;11(4):822-837.

PMID: 33811119 DOI: 10.1158/2159-8290.CD-20-1301

Clinical trials represent a fulcrum for oncology drug discovery and development to bring safe and effective medicines to patients in a timely manner. Clinical trials have shifted from traditional studies evaluating cytotoxic chemotherapy in largely histology-based populations to become adaptively designed and biomarker-driven evaluations of molecularly targeted agents and immune therapies in selected patient subsets. This review will discuss the scientific, methodological, practical, and patient-focused considerations to transform clinical trials. A call to action is proposed to establish the framework for next-generation clinical trials that strikes an optimal balance of operational efficiency, scientific impact, and value to patients. SIGNIFICANCE: The future of cancer clinical trials requires a framework that can efficiently transform scientific discoveries to clinical utility through applications of innovative technologies and dynamic design methodologies. Next-generation clinical trials will offer individualized strategies which ultimately contribute to globalized knowledge and collective learning, through the joint efforts of all key stakeholders including investigators and patients.

Matched MeSH terms: Clinical Trials as Topic*

Fulltext Study of ongoing registered clinical trials on COVID-19: a narrative review

Rabby MII, Hossain F

Sao Paulo Med J, 2020 8 20;138(5):441-456.

PMID: 32813843 DOI: 10.1590/1516-3180.2020.0208.R1.15062020

BACKGROUND: The dangerous SARS-CoV-2 virus first emerged in China in December 2019 and has rapidly spread worldwide. Currently, it has affected more than 2,850,000 people. No vaccine or drug is available yet, and therefore researchers and scientists are striving to identify potential drugs or vaccines for combating this virus. We were unable to find any review of the literature or analysis on ongoing registered clinical trials that reported diagnostic tests, therapeutics, vaccines and devices for COVID-19 along with estimated enrollment, participants' ages, study type, start and completion date, status, treatment/intervention and country.

OBJECTIVE: To review ongoing trials relating to COVID-19.

METHODS: A systematic search for clinical trials was conducted in the ClinicalTrials.gov database up to April 12, 2020. A total of 339 trials relating to COVID-19 were analyzed and key information on each trial was recorded.

RESULTS: Most of the trials were being conducted in the United States and completion of most of them was expected by May 2020. They were mostly on drugs and treatment, while a minority were on diagnostic tests. The analysis showed that hydroxychloroquine was investigated in most of the trials. The trials identified were categorized into five classes: a) diagnostic tests; b) therapeutics; c) biologics and vaccines; d) devices and products; and e) others.

CONCLUSION: The trials identified have potential against COVID-19 that can be applied in treatment processes after the necessary investigations and experiments. Additionally, the items identified were organized in a proper way, which can assist in current research activities.

Matched MeSH terms: Clinical Trials as Topic*

Research in clinical medicine

Lim KJ

Med J Malaya, 1969 Dec;24(2):83-4.

PMID: 4244147

Matched MeSH terms: Clinical Trials as Topic

Fulltext Short review: Implementation of biomedical ethics in Malaysia

Maisarah AS, Nurul Ajilah MK, Siti Amalina MR, Norazuroh MN

Health and the Environment Journal, 2016;7:54-76.

This literature review focuses on the implementation of biomedical ethics in Malaysia based on the government and institutional settings. Insights of the development of biomedical ethics and the responsible entities, particularly the clinical trials that become the emerging field of interest by the government to boost the biomedical research in Malaysia are provided. Some issues and their implications for research and ethical review process in Malaysia are also elucidated. The review indicates the advancement of policies by the government in implementing the biomedical ethics with some affairs that should be a matter to be concerned.
Keywords: Biomedical, ethics, implementation, standards, research ethic committee, good laboratory practice.

Matched MeSH terms: Clinical Trials as Topic

Fulltext Malaysian Phase I Clinical Trial Guidelines

Citation:
Malaysian Phase I Clinical Trial Guidelines. Petaling Jaya: Clinical Research Malaysia; 2017

Matched MeSH terms: Clinical Trials as Topic

Fulltext Sex-disaggregated data in COVID-19 vaccine trials

Vijayasingham L, Bischof E, Wolfe J, Gender and COVID-19 Research Agenda-setting Initiative

Lancet, 2021 Mar 13;397(10278):966-967.

PMID: 33684351 DOI: 10.1016/S0140-6736(21)00384-6

Matched MeSH terms: Clinical Trials as Topic

Fulltext Cardioprotective Effects of Honey and Its Constituent: An Evidence-Based Review of Laboratory Studies and Clinical Trials

Bt Hj Idrus R, Sainik NQAV, Nordin A, Saim AB, Sulaiman N

Int J Environ Res Public Health, 2020 05 21;17(10).

PMID: 32455701 DOI: 10.3390/ijerph17103613

Cardiovascular disease is a major public health burden worldwide. Myocardial infarction is the most common form of cardiovascular disease resulting from low blood supply to the heart. It can lead to further complications such as cardiac arrhythmia, toxic metabolite accumulation, and permanently infarcted areas. Honey is one of the most prized medicinal remedies used since ancient times. There is evidence that indicates honey can function as a cardioprotective agent in cardiovascular diseases. The present review compiles and discusses the available evidence on the effect of honey on cardiovascular diseases. Three electronic databases, namely, PubMed, Scopus, and MEDLINE via EBSCOhost, were searched between January 1959 and March 2020 to identify reports on the cardioprotective effect of honey. Based on the pre-set eligibility criteria, 25 qualified articles were selected and discussed in this review. Honey investigated in the studies included varieties according to their geological origin. Honey protects the heart via lipid metabolism improvement, antioxidative activity, blood pressure modulation, heartbeat restoration, myocardial infarct area reduction, antiaging properties, and cell apoptosis attenuation. This review establishes honey as a potential candidate to be explored further as a natural and dietary alternative to the management of cardiovascular disease.

Matched MeSH terms: Clinical Trials as Topic

Effect of hypoxia on human adipose-derived mesenchymal stem cells and its potential clinical applications

Choi JR, Yong KW, Wan Safwani WKZ

Cell Mol Life Sci, 2017 07;74(14):2587-2600.

PMID: 28224204 DOI: 10.1007/s00018-017-2484-2

Human adipose-derived mesenchymal stem cells (hASCs) are an ideal cell source for regenerative medicine due to their capabilities of multipotency and the readily accessibility of adipose tissue. They have been found residing in a relatively low oxygen tension microenvironment in the body, but the physiological condition has been overlooked in most studies. In light of the escalating need for culturing hASCs under their physiological condition, this review summarizes the most recent advances in the hypoxia effect on hASCs. We first highlight the advantages of using hASCs in regenerative medicine and discuss the influence of hypoxia on the phenotype and functionality of hASCs in terms of viability, stemness, proliferation, differentiation, soluble factor secretion, and biosafety. We provide a glimpse of the possible cellular mechanism that involved under hypoxia and discuss the potential clinical applications. We then highlight the existing challenges and discuss the future perspective on the use of hypoxic-treated hASCs.

Matched MeSH terms: Clinical Trials as Topic*

Fulltext A literature review on beneficial role of vitamins and trace elements: Evidence from published clinical studies

Taheri S, Asadi S, Nilashi M, Ali Abumalloh R, Ghabban NMA, Mohd Yusuf SY, et al.

J Trace Elem Med Biol, 2021 Sep;67:126789.

PMID: 34044222 DOI: 10.1016/j.jtemb.2021.126789

COVID-19 is a kind of SARS-CoV-2 viral infectious pneumonia. This research aims to perform a bibliometric analysis of the published studies of vitamins and trace elements in the Scopus database with a special focus on COVID-19 disease. To achieve the goal of the study, network and density visualizations were used to introduce an overall picture of the published literature. Following the bibliometric analysis, we discuss the potential benefits of vitamins and trace elements on immune system function and COVID-19, supporting the discussion with evidence from published clinical studies. The previous studies show that D and A vitamins demonstrated a higher potential benefit, while Selenium, Copper, and Zinc were found to have favorable effects on immune modulation in viral respiratory infections among trace elements. The principles of nutrition from the findings of this research could be useful in preventing and treating COVID-19.

Matched MeSH terms: Clinical Trials as Topic*

Discontinuation and non-publication of neurodegenerative disease trials: a cross-sectional analysis

Stefaniak JD, Lam TCH, Sim NE, Al-Shahi Salman R, Breen DP

Eur J Neurol, 2017 08;24(8):1071-1076.

PMID: 28636179 DOI: 10.1111/ene.13336

BACKGROUND AND PURPOSE: Trial discontinuation and non-publication represent major sources of research waste in clinical medicine. No previous studies have investigated non-dissemination bias in clinical trials of neurodegenerative diseases.

METHODS: ClinicalTrials.gov was searched for all randomized, interventional, phase II-IV trials that were registered between 1 January 2000 and 31 December 2009 and included adults with Alzheimer's disease, motor neurone disease, multiple sclerosis or Parkinson's disease. Publications from these trials were identified by extensive online searching and contact with authors, and multiple logistic regression analysis was performed to identify characteristics associated with trial discontinuation and non-publication.

RESULTS: In all, 362 eligible trials were identified, of which 12% (42/362) were discontinued. 28% (91/320) of completed trials remained unpublished after 5 years. Trial discontinuation was independently associated with number of patients (P = 0.015; more likely in trials with ≤100 patients; odds ratio 2.65, 95% confidence interval 1.21-5.78) and phase of trial (P = 0.009; more likely in phase IV than phase III trials; odds ratio 3.90, 95% confidence interval 1.41-10.83). Trial non-publication was independently associated with blinding status (P = 0.005; more likely in single-blind than double-blind trials; odds ratio 5.63, 95% confidence interval 1.70-18.71), number of centres (P = 0.010; more likely in single-centre than multi-centre trials; odds ratio 2.49, 95% confidence interval 1.25-4.99), phase of trial (P = 0.041; more likely in phase II than phase IV trials; odds ratio 2.88, 95% confidence interval 1.04-7.93) and sponsor category (P = 0.001; more likely in industry-sponsored than university-sponsored trials; odds ratio 5.05, 95% confidence interval 1.87-13.63).

CONCLUSIONS: There is evidence of non-dissemination bias in randomized trials of interventions for neurodegenerative diseases. Associations with trial discontinuation and non-publication were similar to findings in other diseases. These biases may distort the therapeutic information available to inform clinical practice.

Matched MeSH terms: Clinical Trials as Topic*

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