• 한국발생생물학회:학술대회논문집
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• 한국발생생물학회 2009년도 특별 Symposium
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• pp.43-45
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• 2009

• 응용통계연구
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• 제32권1호
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• pp.1-13
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• 2019

최근에 제안된 심리스(seamless) 제 2상/제 3상 임상시험 디자인은 기존의 임상시험 디자인들과 비교하여 피험자수를 줄일 수 있을 뿐만 아니라 임상 개발 시간을 단축시킬 수 있다는 장점을 가지고 있어 임상시험연구자들의 많은 관심을 끌고 있다. 또한 제 3상 시험을 단독으로 진행 하였을 때보다 더 높은 검정력을 가질 수 있으므로 임상시험에서 매우 효율적이라 말할 수 있다. 본 논문에서는 제 2상에서 최고효과 용량군을 선정하기 위한 여러 가지 다중가설 검정방법들을 제시하고 제 2상에서 최고효과 용량군을 선정한 후에 제 2상과 제 3상을 결합하는 여러 가지 유의확률 결합검정방법들을 제시하였다. 또한 모의실험을 통해서 심리스 제 2상/제 3상 임상설계가 적용되었을 때 여러 가지 방법들을 비교함으로써, 제 2상/제 3상 표본의 크기 조합이나 분산의 크기가 다른 여러 가지 상황에서 가장 적절한 방법을 선택하는 가이드라인을 제시하고자 한다.

• Asian Pacific Journal of Cancer Prevention
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• 제14권4호
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• pp.2181-2184
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• 2013

Prostate cancer is the most common malignancy in men in the United States. Surgery or radiation are sometimes unsatisfactory treatments because of the complications such as incontinence or erectile dysfunction. Selenium was found to be effective to preven prostate cancer in the Nutritional Prevention of Cancer Trial (NPC), which motivated two other clinical trials: the Selenium and Vitamin E Cancer Prevention Trial (SELECT) and a Phase III trial of selenium to prevent prostate cancer in men with high-grade prostatic intraepithelial neoplasia. However, these two trials failed to confirm the results of the NPC trial and indicated that the selenium may not be preventive of prostate cancer. In this article we review the three clinical trials and discuss some different points which might be potential factors underlying variation in results obtained.

• Journal of Acupuncture Research
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• 제15권2호
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• pp.183-198
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• 1998

This study was done in order to present clinical trial method for safety of herb-acupuncture. The results were summerized as follow: In case of western medicine, clinical trial divides into four phase 1. Phase I: Investigate safety and drug movement for health people. 2. The first phase II: Investigate safety, effectiveness for the limited patient. The late phase II: Investigate propriety of an applicable disease, the way to use and dose. 3. Phase III: Through the comparative, public trial, investigate a final, applicable disease and side effect. 4. Phase IV: After NDA, investigate safety and effectiveness for the wide patients. In case of herb-acupuncture, we have to investigate the following for safety and effectiveness 1. Drug dose: Decide with 1/2 or 1/3 of oral dosage or a basis of animal's of maximum dosage or a ratio of man and animal. 2. Toxicity: Examine blood, urine, liver function, EKG, after herb-acupuncture during acertain period of time. 3. Regional response: Estimate response of swelling, redness, pruritus. etc 4. Treatment effectiveness: After exactly diagnosis, estimate effectiveness with a objective guide post.

• 한국통계학회:학술대회논문집
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• 한국통계학회 2002년도 추계 학술발표회 논문집
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• pp.79-83
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• 2002

A phase III clinical trial of a new drug for neutropenia induced by chemotherapy is presented and consider adding random effects in crossover design which was used in the clinical study. The diagnostics for its heteroscedasticity based on score statistic is derived for detecting homoscedasticity of errors in crossover design. A small simulation study is peformed to investigate the finite sample behaviour of the test statistic which is known to have an asymptotic chi-square distribution under the null hypothesis.

• Journal of Gastric Cancer
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• 제8권2호
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• pp.57-64
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• 2008

현재 국소 위암에서 유일한 완치적 치료법은 수술적 절제이나 적절한 수술적 치료에도 불구하고 상당 수의 환자들이 재발을 경험한다. 이에 다학제적 병용 치료 전략에 대해 많은 관심이 있어왔고 특히 최근에는 암의 병기 감소, 근치적 절제률의 증가, 미세 원격전이의 조기 치료 등의 가능성을 가지는 수술 전 선행항암화학요법에 대한 관심이 증대되고 있다. 최근의 3상 임상 연구인 MAGIC trial은 수술 전후 항암화학요법이, 수술 단독에 비해, 병리학적 병기를 감소시키며 국소 재발과 원격 전이를 감소시켜 생존율을 향상시킴을 보고하였고 또 다른 3상 연구인 FNLCC 94012/FFCD 9703 trial 역시, 수술 전후 항암화학요법이 근치적 절제율과 생존율을 향상시킴을 보고하였다. 두 연구는 수술 전후 항암화학요법에 대한 것이지만 수술 후 보조항암화학요법의 불량한 치료 순응도에 비추어 볼 때 치료성적의 향상은 주로 수술 전 선행항암화학요법에 기인하는 것으로 생각된다. 상기 연구들이 이루어진 서양과 달리 광범위(D2) 림프절 절제술을 표준적 치료로 시행하고 있는 한국의 현실에서 이들 연구결과를 그대로 적용하기에는 어려움이 있으나 한국에서 이루어진, 국소 진행성 위암 환자를 대상으로 한 몇 가지 임상 연구 역시 선행항암화학요법을 통한 근치적 절제률의 증가 및 병기 감소 효과를 시사하였다. 이러한 고무적인 치료 성적에 근거하여 향후 수술 전 또는 수술 전후 항암화학요법이 국소 위암에서 표준적인 치료 전략으로 자리잡을 수 있을 지 결론을 짓기 위해서는 대규모 임상 연구가 시행되어야 할 것이다.

• Journal of Gastric Cancer
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• 제19권2호
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• pp.157-164
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• 2019

Purpose: Although standard radical gastrectomy is recommended after noncurative resection of endoscopic submucosal dissection (ESD) for early gastric cancer in most cases, residual tumor and lymph node metastasis have not been identified after surgery. The aim of this study is to evaluate the feasibility of sentinel node navigation surgery after noncurative ESD. Materials and Methods: This trial is an investigator-initiated, multicenter prospective phase II trial. Patients who underwent ESD for clinical stage T1N0M0 gastric cancer with noncurative resections were eligible. Qualified investigators who completed the prior phase III trial (SENORITA 1) are exclusively allowed to participate. In this study, 2 detection methods will be used: 1) intraoperative endoscopic submucosal injection of dual tracer, including radioisotope and indocyanine green (ICG) with sentinel basins detected using gamma-probe; 2) endoscopic injection of ICG, with sentinel basins detected using a fluorescence imaging system. Standard laparoscopic gastrectomy with lymphadenectomy will be performed. Sample size is calculated based on the inferior confidence interval of the detection rate of 95%, and the calculated accrual is 237 patients. The primary endpoint is detection rate, and the secondary endpoints are sensitivity and postoperative complications. Conclusions: This study is expected to clarify the feasibility of laparoscopic sentinel basin dissection after noncurative ESD. If the feasibility is demonstrated, a multicenter phase III trial will be initiated to compare laparoscopic sentinel node navigation surgery versus laparoscopic standard gastrectomy in early gastric cancer after endoscopic resection.

• 약학회지
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• 제50권6호
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• pp.386-392
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• 2006

Pramlintide, a synthetic analogue of human hormone amylin, is the first of a new class of amylinomimetic compounds. Present study was undertaken to compile and analyze the clinical trials of pramlintide, and thereby to facilitate the design of the bridging study for the earlier introduction of the drug, which might be needed by diabetes patients in Korea. Sixty-two articles from Pubmed and MEDLINE search were used to analyze the trials of pramlintide along with prescribing information and New Drug Application packet obtained form the manufacturer. The efficacy of the new drug was attributed to three mechanisms: delay of gastric emptying time, inhibition of post-prandial glucagon secretion, and reduction of food intake by enhanced satiety. Clinical trials consistently identified the effectiveness of the drug for the treatment of type 1and type 2 diabetes who have failed to achieve glycemic control despite optimal therapy with insulin. However, the six pivotal Phase III clinical trials were peformed with mostly caucasian and some black and hispanic people. None of the trials documented the proportion of either Asian or Korean participants. Since Korean diabetes patients show different epidemiology and characteristics in their disease state, it appears that the bridging study of pramlintide should be designed in the level of full scale Phase III clinical trial along with pharmacokinetic and pbarmacodynamic studies.

• IMMUNE NETWORK
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• 제21권1호
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• pp.5.1-5.22
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• 2021

Coronavirus disease 2019 (COVID-19) has developed as a pandemic, and it created an outrageous effect on the current healthcare and economic system throughout the globe. To date, there is no appropriate therapeutics or vaccines against the disease. The entire human race is eagerly waiting for the development of new therapeutics or vaccines against severe acute respiratory syndrome coronavirus-2 (SARS-CoV-2). Efforts are being taken to develop vaccines at a rapid rate for fighting against the ongoing pandemic situation. Amongst the various vaccines under consideration, some are either in the preclinical stage or in the clinical stages of development (phase-I, -II, and -III). Even, phase-III trials are being conducted for some repurposed vaccines like Bacillus Calmette-Guérin, polio vaccine, and measles-mumps-rubella. We have highlighted the ongoing clinical trial landscape of the COVID-19 as well as repurposed vaccines. An insight into the current status of the available antigenic epitopes for SARS-CoV-2 and different types of vaccine platforms of COVID-19 vaccines has been discussed. These vaccines are highlighted throughout the world by different news agencies. Moreover, ongoing clinical trials for repurposed vaccines for COVID-19 and critical factors associated with the development of COVID-19 vaccines have also been described.

• 한국임상약학회지
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• 제5권2호
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• pp.33-49
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• 1995

The purpose of this study is to understand present situation of clinical trials, and evaluate the preparedness of the desiRnated institutions to abide by GCP(Good Clinical Practice) standards during clinical trials. Survey on the status of clinical trials was conducted for the desienated 83 clinical trial hospitals, and response rate was $95.2\%$. The results showed that 39 hospitals have conducted clinical trials to obtain drug manufacturing approval from 1990 to 1994. Most of them were trials on Phase III. Only $46.8\%$ of the institutions had sufficient human resources to perform the clinical trials. Institutions which established IRB(Institutional Review Board) accounted for 41 or $51.9\%$, but those who have a protocol evaluation guideline, or Adverse Drug Reaction(ADR) reporting system were only 12, and 21 Places, respectively. Regarding supervision of the investigational drugs, less than 30 institutions designated pharmacist as a supervisor. In conducting clinical trials, $97.4\%$ of trials had high rates of prior consent of testees, but only part of them-$61.7\%$-gave written consent. The level of conducting GCP is found to be unsatisfactory. Institutions must build the appropriate infrastructure and government must prepare in order to protect testees' rights as well as to ensure validity of the results.