• The Korean Society of Law and Medicine
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• v.21 no.2
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• pp.163-207
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• 2020

Korea has been positioned as the leading country in the industry of clinical trials as the clinical trail of Korea has developed for the recent 10 years. Clinical trial has plays a significant role in the development of medicine and the increase of curability. However, it has inevitable risk as the purpose of the clinical trial is to prove the safety and effectiveness of new drugs. Therefore, the clinical trial should be controlled properly to protect the health of the subjects of clinical trial and to ensure that they exercise a right of self-determination. In this context, the fiduciary duties of doctors who conduct clinical trials is especially important. The Pharmaceutical Affairs Act and the relevant regulations define several duties of doctors who conduct clinical trials. In particular, the duty to protection of subjects and the duty to provide information constitute the main fiduciary duties to the subjects. Those are essentially similar to the fiduciary duties of doctors in usual treatment from the perspective of the values promoted by the law and the content of the law. Nonetheless, clinical trials put more emphasis on the duties to provide explanation than in usual treatment. Further research and study are required to establish the concrete standard for the duty of care. However, if the blind pursuit of higher standards for the duty of care or to pass the burden of proof to doctors may result in disrupting the development of clinical trials, limiting the accessibility of patients to new treatment and even violating the principle of sharing damage equally and properly. In addition to these duties, the laws of clinical trials define several duties of doctors. Any decision on whether the violation of the law constitutes the violation of the fiduciary duty and justifies the demand for compensation of damages should be based on whether relevant law aims to protect the safety and benefit of subjects, even if in an incidental way, the degree to which such violation breaches the values promoted by the law and the concrete of violation of benefit of law, the detailed acts of such violation. The legal interests of the subjects can be protected effectively by guaranteeing compliance with those duties and establishing judicial and administrative controls to ensure that the benefit of subjects are protected properly in individual cases.

• Asian Pacific Journal of Cancer Prevention
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• v.16 no.9
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• pp.3937-3940
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• 2015

Background: Pancreatic cancer risk is increased in patients with type 2 diabetes, while being reduced by metformin treatment. However, it is unclear whether metformin could be associated with clinical outcomes of patients with pancreatic cancer and concurrent type 2 diabetes. Materials and Methods: A pooled analysis of 4 publications including 1,429 patients was performed to investigate the association of metformin and overall survival(OS) in patients with pancreatic cancer and concurrent type 2 diabetes. Results: A borderline significant relative survival benefit was found in metformin treated patients compared with non-metformin treated patients (hazard ratio 0.80; 95% CI: 0.62-1.03). Conclusions: These results suggest that further investigation is warranted of whether metformin may benefit the survival of patients with pancreatic cancer and concurrent type 2 diabetes.

• YAKHAK HOEJI
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• v.51 no.3
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• pp.186-193
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• 2007

This study was performed to analyse the economic value of abciximab which is used in PCI to prevent high-risk patients with ischemic complications. The effectiveness of abciximab was extracted from published clinical trials by search-ing CCIS, and the direct medical costs relevant to using abciximab were estimated from the NHI claims database. The results in terms of cost per life-year gained (LYG) and cost per QALY gained showed that abciximab was cost-effective enough to deserve its cost. Social net benefit resulting from abciximab in PCI was estimated to be 60-70 billion Won per year.

• Clinical and Experimental Pediatrics
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• v.53 no.3
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• pp.273-285
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• 2010

Completion of the human genome project has allowed a deeper understanding of molecular pathophysiology and has provided invaluable genomic information for the diagnosis of genetic disorders. Advent of new technologies has lead to an explosion in genetic testing. However, this overwhelming stream of genetic information often misleads physicians and patients into a misguided faith in the power of genetic testing. Moreover, genetic testing raises a number of ethical, legal, and social issues. Diagnostic genetic tests can be divided into three primary but overlapping categories: cytogenetic studies (including routine karyotyping, high-resolution karyotyping, and fluorescent in situ hybridization studies), biochemical tests, and DNA-based diagnostic tests. DNA-based testing has grown rapidly over the past decade and includes preandpostnatal testing for the diagnosis of genetic diseases, testing for carriers of genetic diseases, genetic testing for susceptibility to common non-genetic diseases, and screening for common genetic diseases in a particular population. Theoretically, once a gene's structure, function, and association with a disease are well established, the clinical application of genetic testing should be feasible. However, for routine applications in a clinical setting, such tests must satisfy a number of criteria. These criteria include an acceptable degree of clinical and analytical validity, support of a quality assurance program, possibility of modifying the course of the diagnosed disease with treatment, inclusion of pre-and postnatal genetic counseling, and determination of whether the proposed test satisfies cost-benefit criteria and should replace or complement traditional tests. In the near future, the application of genetic testing to common diseases is expected to expand and will likely be extended to include individual pharmacogenetic assessments.

• Korean Journal of Clinical Pharmacy
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• v.34 no.2
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• pp.79-99
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• 2024

Background: There was an important revision of the Korean Clinical Practice Guideline for Stroke (KCPGS) for antithrombotic therapy in patients with acute ischemic stroke in 2022. This review is to provide an updated information in this revision. Methods: The revision history by year after the first announcement was examined for each topic, focusing on antithrombotic therapy during acute phase which was revised in 2022. We compared before and after the revision, and investigated the clinical outcomes presented as evidence. It was also compared with the current U.S. guidelines. Results: The major changes about antiplatelet therapy are a clause stating that dual antiplatelet therapy with clopidogrel and aspirin initiated within 24 hours from the stroke onset and maintained for up to 21-30 days is recommended as an acute treatment, as well as the clause that antithrombotic therapy may be initiated within 24 hours after intravenous thrombolytics and that the use of glycoprotein IIb/IIIa receptor antagonists can be considered in highly selected patients as rescue therapy taking into account of benefit and risk. The change to the use of anticoagulants is that it may be reasonable to start oral anticoagulant between 4 and 14 days after stroke onset for patients with acute ischemic stroke and atrial fibrillation. Conclusions: It will be helpful in improving health outcomes for clinical pharmacists to be aware of the latest information for antithrombotic therapy and to actively use it in pharmaceutical care of stroke patients.

• Korean Journal of Clinical Pharmacy
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• v.26 no.2
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• pp.97-106
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• 2016

Background: Sevelamer is associated with reduced complications of chronic kidney disease-mineral bone disorder (CKD-MBD) resulted from hyperphosphatemia, which may contribute mortality, in CKD patients with dialysis. So far clinical outcomes of sevelamer on mortality and risk of cardiovascular mortality related to CKD-MBD are debating. Purpose of this study was to evaluate the effectiveness of sevelamer HCl on mortality of secondary hyperparathyroidism (SHPT), risk of cardiovascular mortality and, frequency of osteopathy in end stage renal disease (ESRD) patients with dialysis. Methods: We retrospectively reviewed the electronic medical records of 536 patients with ESRD, who were admitted for moderate to severe SHPT, for 36 months. 75 patients who met inclusion criteria were evaluated for the efficacy of sevelamer (mean serum iPTH = 487.5 pg/mL). Results: Sevelamer intervention was not associated with increased three-year survival time compared with non-sevelamers group [average survival month: 30.4 months in sevelamer group, 26.8 months in non-sevelamer group, p = 0.463]. Sevelamer intervention was not associated with significant mortality benefit and cardiovascular mortality benefit as compared to non-sevelamer group [sevelamer group: non-sevelamer group, all-cause mortality (iPTH > 600 pg/mL): 14.3% (1/34): 20% (1/41) p = 0.962, OR = 0.935, 95% CI, 0.058-14.98, heart disease mortality: 6.67% (2/30): 0% (0/32) p = 0.138]. Sevelamer was not associated with significantly lower cumulative incidence of osteopathy compared to non-sevelamer group (sevelamer group: non-sevelamer group, 5.9% (2/34):9.8% (4/41); p = 0.538; OR = 0.578; 95% CI, 0.099-3.367). Conclusion: Sevelamer was not associated with decreased all-cause mortality and risk of cardiovascular mortality compared to non-sevelamer group in ESRD patients with SHPT.

• Journal of Korean Neurosurgical Society
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• v.63 no.4
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• pp.470-476
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• 2020

Objective : The objective of this study was to develop a score to predict patients with acute ischemic stroke (AIS) who will not benefit from endovascular treatment (EVT) using computed tomographic angiography (CTA) parameters. Methods : The CTA-ABC score was developed from 3 scales previously described in the literature: the Alberta Stroke Program Early CT Score (0-5 points, 3; 6-10 points, 0), the clot burden score (0-3 points, 1; 4-10 points, 0), and the leptomeningeal Collateral score (0-1 points, 2; 2-3 points, 0). We evaluated the predictive value of CTA parameters associated with symptomatic intracranial hemorrhage (sICH) or malignant middle cerebral artery infarction (MMCAI) after EVT and developed the score using logistic regression coefficients. The score was then validated. Performance of the score was tested with an area under the receiver operating characteristic curve (AUC-ROC). Results : The derivation cohort consisted of 115 and the validation cohort consisted of 40 AIS patients. The AUC-ROC was 0.97 (95% confidence interval [CI], 0.94-0.99; p<0.001) in the derivation cohort. The proportions of patients with sICH and/or MMCAI in the derivation cohort were 96%, 73%, 6%, and 0% for scores of 6, 5, 1, and 0 points, respectively. In the validation group, the proportions were similar (90%, 100%, 0%, and 0%, respectively) with an AUC-ROC of 0.96 (95% CI, 0.90-1.00; p<0.001). Conclusion : Our CTA-ABC score reliably assessed risk for sICH and/or MMCAI in patients with AIS who underwent EVT. It can support clinical decision-making, especially when the need for EVT is uncertain.

• The Korean Journal of Applied Statistics
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• v.9 no.2
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• pp.95-108
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• 1996

There are many clinical trials where a large portion of the patients are cured of disease. In such a case, one might be more interested in testing the differences in cure rates rather than other types of differences in failure distribution. For ethical and economic reasons, clinical trials must be repeatedly monitored for evidence of treatment benefit or harm. In this article, we examined by simulation the properties of nonparametric group sequential methods for comparing the cure rates between two treatment groups during the trial in a wide range of alternatives, censoring rates and cure rates.

• Clinical and Experimental Pediatrics
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• v.52 no.1
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• pp.1-5
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• 2009

Children are not small adults and there is a need to carry out specific trials that cannot be performed in adults. In general, children (minors) are unable to consent but their assent should be obtained using age appropriate information. Institutional Review Board (IRB) need paediatric expertise to balance the benefits and risks of research in children. The lack of consent has implications on the design, analysis and the choice of comparators used in the trials, which should only be performed by trained investigators with paediatric experience. Pain, fear, distress and parental separation should be prevented and minimised when unavoidable. The children requires even more careful review. Children represent a vulnerable population with developmental, physiological and psychological differences from adults, which make age- and development- related research important for their benefit. Finally, criteria for the protection of children in clinical trials therefore need to be laid down. Specific protection should be defined for research performed in children, at all stages and ages.

• The Journal of the Korean dental association
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• v.51 no.1
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• pp.39-45
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• 2013

Radiographic examinations are used to discover and define the type and extent of disease in many clinical situations. Currently, it is common for dental patients to receive dental radiographic examinations on a routine schedule with little variation in spite of different patient signs and symptoms. Such routine scheduling of radiographic examinations may result in unnecessary patient exposure. There is also the possibility of under-utilization of radiography; this can result in inadequate or excessively delayed diagnosis. Patient selection criteria are descriptions of clinical conditions derived from patient signs, symptoms and history that identify patients who are likely to benefit from a particular radiographic examination. It makes possible making individual decisions based on history, clinical examination and risk factors. The radiographic selection criteria of dentistry have been revised in accordance with recent guidelines and peer-reviewed research in USA and Europe, but the studies of these subjects are not sufficient in our nation. In this review article, the relating factors and update necessity of radiographic selection criteria are discussed.