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Sri Lanka Clinical Trials Registry

Here’s everything you need to know about Sri Lanka Clinical Trials Registry. Find all the information it in this article.

In 2019, 96,903 dengue cases and 90 clinically confirmed dengue deaths have been reported from all components of the country. The investigator should full an online form to register a research, and the ethics evaluate committee should approve before the enrollment of topics. Any trial designed to test the efficacy of a health care intervention in human members requires registration. A comparative analysis of essential public scientific trial registries, and a proposal for an interim best one. Fees can be paid to the SLMA Office by money, or by cheque in favour of the “Sri Lanka Medical Association”.

The Sri Lanka Clinical Trials Registry is a Registry for clinical trials involving human topics, performed in Sri Lanka or abroad. The SLCTR is a Primary Registry linked to the Registry Network of the International Clinical Trials Registry Platform of the WHO (WHO-ICTRP). It is a not-for-profit Registry, with free and open access to researchers, clinicians, and the common public. According to SLCTR statistics, over the past 10 years, they’ve received over 324 applications for clinical trials, out of which sixteen have been multi-country studies.

World Medical Association Declaration Of Helsinki Moral Rules For Medical Analysis Involving Human Subjects

A sturdy regulatory framework and moral reviewing course of have minimized authorized loopholes guaranteeing the rights, safety, and well-being of trial individuals which are protected. Moreover, the adoption of latest expertise in clinical analysis and the rise of the pharmaceutical industry encourages and creates alternatives for extra clinical trials to be carried out in Sri Lanka which, in turn, influences the expansion of the business.

A model is proposed for reviewing clinical trial results which is free from publication bias based mostly on the selection of trials registered upfront in a registry, and the value and significance of a world registry of all medical trials are illustrated. Prospective registration of all medical trials involving human subjects is now a requirement for trial publication in International Biomedical Journals.

Establishing The Sri Lanka Clinical Trials Registry

In summary, Sri Lanka is a perfect destination for the global medical trial business due to our favorable nationwide policies, rising financial system, and speedy digitalization directly influencing the rising world market measurement of clinical trials. Making an setting favorable to analysis partnership while guaranteeing the safe and moral conduct of medical trials has been a repetitive topic for dialog and discussion in the nation.

The responsibility for registering a trial lies with the principal investigator or principal sponsor of the trial. For multi-centre trials, the lead principal investigator or lead sponsor should take duty for registration. In the primary 10 years of operation, the SLCTR registered 210 clinical trials, a majority of which were randomized managed trials and most Principal Investigators have been affiliated with a college. This paper describes the experience of the first 10 years on the Sri Lanka Clinical Trials Registry and describes the work that was done to determine a database of scientific trials in Sri Lanka.

Is This Medical Trial Absolutely Registered? A Statement From The International Committee Of Medical Journal Editors

According to the Global Burden of Disease Study in 2010, the highest-ranking for the causes of variety of years of life lost in Sri Lanka is untimely demise caused by ischemic coronary heart disease, self-harm, cerebrovascular illnesses, strokes, and diabetes. More than three-quarters of all deaths are due to NCDs, and almost 1 in 5 folks die prematurely from NCDs. According to the most recent STEPS survey for NCDs, 1 out of 4 individuals have raised blood stress, and a third are chubby. Recent statistics also present that 1 in 12 adults endure from diabetes, which give a total of 1.16 million diabetic adults nationally.

This document describes the aims and obligations of the World Medical Association and its members and supplies a history of its actions and activities. The registry was recognized in 2008 as a Primary Registry Network of the International Clinical Trials Registry Platform of the World Health Organization.

A Quantity Of Publication Of Reports Of Drug Trials

The SLMA is the premier professional medical association in Sri Lanka, which brings together medical practitioners of all branches of medication. It is the oldest medical organization in Ausralasia, with a proud history courting again to 1887.

In the past, many of the medical trials included adults solely, and trials to be conducted on child individuals under 12 years had been comparatively decrease. The SLCTR statistics also showed that out of 210 trials, 164 included male and female members, whereas forty three trials were performed on females solely and three trials on males solely. In the previous 10 years, diabetes made up for greater than 14% of registered trials and was probably the most researched therapeutic space. This was adopted by pregnancy and its outcomes (12.4%) and infections/ infestations (7.14%).

Consciousness Of Medical Trial Registration Among Healthcare Professionals: An Observational Research

The SLCTR has helped reinvigorate the analysis community in Sri Lanka, particularly on the topics of medical trials. The SLCTR is an internet-based registry, with worldwide free and open access to researchers, clinicians, and most of the people. As a developing nation with sudden urbanization and life-style changes, non-communicable diseases are a challenge to the nationwide economy and public health.

SLCTR statistics over the previous 10 years suggest that the clinical trial industry in Sri Lanka is opportunistic when it comes to progress within South Asia and that is but to be identified and addressed. Prospective registration of all scientific trials involving human participants is a requirement for trial publication in international biomedical journals. The Sri Lanka Clinical Trials Registry is an internet-based, not-for-profit medical trials registry offering free entry to researchers, clinicians, funding companies and the public.



The prevalence of depressive disorders in Sri Lanka is 4.1%, which isn’t notably completely different from the Southeast Asia region prevalence (4.4%). Sri Lanka being a tropical island, the climate is regularly affected by mosquito-borne diseases. Although Sri Lanka has efficiently eradicated malaria, dengue fever makes seasonal outbreaks causing a considerable number of deaths.

Adhesion To Who Trial Registration Information Set

The trial was carried out in collaboration with the Ministry of Health and the Epidemiology Unit, and the first efficacy results had been printed in the New England Journal of Medicine . An investigator-sponsored multi-country trial that geared toward testing the speculation that low doses of three drugs may achieve better blood strain control for sufferers with mild-to-moderate hypertension was performed in Sri Lanka.

Registry Snapshot: Sri Lanka Clinical Trials Registry (slctr)

The legislation secures Contract Research organizations and clinicians engaged in medical trials and the trial individuals from possible accidents and entrusting their authorized rights in trial participation. The SLCTR presently accepts solely scientific trials with a health-related intervention and does not register observational studies. It encourages potential registration of all medical trials, and does not accept trials for retrospective registration. It meets all the necessities specified by the WHO-ICTRP and the International Committee of Medical Journal Editors . The Sri Lanka Clinical Trials Registry is working together with its companion stakeholders to facilitate research within the country, and to make sure that scientific trials carried out in Sri Lanka meet the very best ethical and scientific requirements.

The Sri Lanka Scientific Trials Registry–moving Forward

An application processing fee for trial registration is levied by the Sri Lanka Clinical Trials Registry to meet administrative costs. The SLCTR is managed by the SLCTR Committee, an advisory group appointed by the Sri Lanka Medical Association . The SLMA is the premiere professional medical affiliation in Sri Lanka, and is the oldest medical organization in Australasia with a proud historical past courting back to 1887.

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For clinical trials that are recruiting sufferers in Sri Lanka, ethics approval should be obtained from one of the ethics evaluate committees given beneath, as per the rules laid down by the Subcommitte on Clinical Trials, Ministry of Health, Sri Lanka. Sri Lanka has a robust regulatory framework administrated by the National Medicines Regulatory Authority in compliance with GCP requirements set by the International Council for Harmonization and the US Food and Drug Administration requirements. The NMRA’s guidelines printed on October 15, 2019, provide a comprehensive steerage to assist clinicians, scientists, sponsors, and research organizations to turn into acquainted with existing procedures and necessities for the conduct of clinical trials in Sri Lanka. NMRA offers regulatory approval, related import licenses, and certificates required for the scientific trials. The NMRA Act, No. 5 of 2015 and laws made thereafter have strengthened the legal framework for clinical trials and are aligned with ICH-GCP guidelines.