• 대한한의학회지
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• 제40권1호
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• pp.124-152
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• 2019

Objectives: This study aimed to ascertain what should be considered in the "Guideline for Clinical Trials with Herbal Medicinal Products for Colorectal Cancer" by analyzing the existing guidelines and clinical trials. Methods: The development committee searched guidelines for herbal medicinal products for colorectal cancer that have already been developed. Then, clinical trials for colorectal cancer using herbal medicine were searched. The searched trials were analyzed in terms of inclusion and exclusion of participants, intervention, comparator, outcomes and trial design. Then, we compared the results of our analysis with the regulations and guidelines of the Ministry of Food and Drug Safety in order to identify the issues we will have to consider when making the "Guideline for Clinical Trials with Herbal Medicinal Products for Colorectal Cancer". Several guidelines for anti-tumor agents and clinical trials with herbal medicinal products were searched on the national institution homepage. In addition, 12 articles were searched using a combination of the following search terms: 'colorectal neoplasms', 'herbal medicine', 'Medicine, Korean traditional', 'Medicine, Chinese Traditional', 'medicine, East Asian medicine', 'medicine, Kampo', etc. Results: The characteristics of participants were various, such as people with medical histories of surgeries or recurrent cancers or who complained of chemotherapy-induced side effects. The types of interventions were also various and included decoctions, powders, intravenous fluids, intraperitoneal injections and gargles. Comparators used included placebos and conventional treatments. The outcome measurements used in the studies were quality of life, symptom score, tumor response, and survival duration, etc. Safety was evaluated by recording adverse events. Conclusions: Findings were made by reviewing existing guidelines and comparing them with clinical trials for colorectal cancer and herbal medicinal products. These results will be utilized in the development of the "Guideline for Clinical Trials with Herbal Medicinal Products for Colorectal Cancer".

• 한국의료질향상학회지
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• 제2권1호
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• pp.86-109
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• 1995

Clinical trials of drugs on humans is the final and most important stage in evaluating the safety and efficacy of the drugs. Good Clinical Practice(GCP) standards were announced in 1987 to protect testees' rights as well as to ensure validity of the clinical trial results, but its implementation has been delayed until now. The purpose of this study is to evaluate the preparedness of the designated institutions to abide by GCP standards during clinical trials, and thereby to determine GCP implementability at the institutions. Survey on the status of clinical trials was conducted for the designated 83 clinical trial hospitals. Response rate was 95.2%. Donabedian's quality assessment model was applied as the basic framework for the study. And the relative - weights for the evaluation items were determined by expert's evaluation. Among the designated 83 hospitals, 39 conducted clinical trials to obtain drug manufacturing approval from 1990 to 1994. Only 19 institutions are found to be able to meet the requirements of KGCP. Structure variables - manpower, organization, and facility -, which are the basic elements for GCP, are evaluated as unsatisfied in many hospitals. Institutions which established IRB 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 institutions, respectively. Also, the institutions providing educational programs on conducting clinical trials are few - 20. The study results indicates that the level of conducting KGCP is unsatisfactory. However, more institutions are expected to be able to meet the standards soon because GCP standards does not require so much regulation on facilities, but stress importance on research methodology and human right. At present as the institutions for clinical trials are primarily training hospitals with residency programs, such efforts as education will accelerate the implementability of GCP in Korea. Institutions must build the appropriate infrastructure and government must prepare to strongly enforce KGCP before it can successfully take place.

• Journal of Acupuncture Research
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• 제33권3호
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• pp.145-152
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• 2016

Objectives : This study aimed to investigate both cancer patients' willingness to participate (WTP) in clinical trials and its associated factors. Methods : We searched MEDLINE (PubMed) for studies that had investigated cancer patients' WTP in clinical trials. Search terms included 'willingness to participate', 'cancer' and 'trial'. Studies published within the last five years up to July 26, 2016 were potentially eligible. Results : Of 44 initial hits, 14 studies (12 quantitative and 2 qualitative) were included. Two out of the 14 studies investigated WTP in an acupuncture trial. Study designs, such as WTP measurement methods, investigation settings, and type of cancer, varied. The proportion of participants with a WTP was widely distributed between the studies (median 48.6 %, range 11.1 % to 88.3 %). Factors associated with WTP included various socio-demographic factors, clinical factors, participants' knowledge/attitudes toward clinical trials, travel distance, information from physicians, and trust toward physicians. Conclusion : WTP and its associated factors were variable across the reviewed studies, which might be due to different research methods and contexts. Whether or not common factors associated with cancer patients' WTP in clinical trials exist remains unclear and thus warrants further research.

• 대한예방의학회:학술대회논문집
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• 대한예방의학회 1994년도 교수 연수회(역학)
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• pp.324-331
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• 1994

To promote the inclusion of quality of life (QOL) end-points In clinical research on cancer, the National Cancer Institute (USA) sponsored a workshop on QOL assessment In cancer clinical trials In July, 1990. Experts In clinical trials and QOL research formed four working groups to Identify current areas of cancer treatment In which QOL end-points are most Important; to discuss methodologic problems In QOL assessment; to address common problems In Implementing clinical studies with QOL end-points; and to consider statistical Issues In design, Implementation, and data analysis. Recommendations made by the working groups are summarized in this paper.

• Korean Journal of Acupuncture
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• 제25권2호
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• pp.71-85
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• 2008

Objective : Acupuncture, one of the Oriental medical treatment techniques in East Asia, is growing in popularity all over the world. Based on bibliographical and clinical data, the depth of needling, i.e. superficial or deep needling, has been considered to be a variable as potential modifiers of needling effects, such as localization, manipulation of the needle, or elicitation of DeQi. The purpose of this review is to summarize clinical trials using minimal acupuncture and to evaluate its appropriateness as a control. Methods : A survey of computerized literature searches for randomized controlled trials using minimal acupuncture revealed that a total of 10 studies were published until April 2008. Results : Results obtained from clinical trials showed that acupuncture were more effective than minimal acupuncture in 3 out of 10 trials, while others were no more effective than control. However, minimal acupuncture might neither be a inert placebo nor be indiscriminable. Conclusion : Minimal acupuncture as 'placebo' controls seems misleading and scientifically unacceptable.

• 대한한의학회지
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• 제38권3호
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• pp.124-142
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• 2017

Objectives: This study aimed to learn what should be considered in [Guideline of Clinical Trial with Herbal Medicinal Product for Gastric Cancer)] by analyzing the existing guidelines and clinical trials. Methods: The development committee searched guidelines for herbal medicinal product or gastric cancer developed already. Then, clinical trials for gastric cancer using herbal medicine were searched. The searched trials were analyzed in terms of inclusion and exclusion of participants, intervention, comparator, outcomes and trial design. Then, we compared the results of analysis with the regulations and guidelines of Ministry of Food and Drug Safety to suggest the issue that we will have to consider when making the [Guideline of Clinical Trial with Herbal Medicinal Product for Gastric Cancer]. Results: As a result, few guidelines for anti-tumor agent and clinical trial with herbal medicinal product were searched in the national institution homepage. In addition, 10 articles were searched by using the combination following search term; 'stomach neoplasm', 'herbal medicine', 'Medicine, Korean traditional', 'Medicine, Chinese Traditional', 'TCM', 'TKM', 'trial'. Most trials included gastric cancer participants with medical history of operation. The type of intervention was various such as decoction, granules, and fluid of intravenous injection. Comparators were diverse such as placebo, conventional treatment including chemotherapy and nutritional supplement. The most frequently used outcome for efficacy was quality of life. Besides, the symptom score, tumor response, and survival rate were used. Safety was investigated by recording adverse events. Conclusion: We found out some issue by reviewing the existing guidelines and comparing it with clinical trials for gastric cancer and herbal medicinal products. These results will be utilized for developing [Guideline of Clinical Trial with Herbal Medicinal Product for Gastric Cancer].

• 한방비만학회지
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• 제19권1호
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• pp.56-67
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• 2019

Objectives: The purpose of this study is to review clinical studies of herb medicine and acupuncture treatment on obesity in menopausal women. Methods: Key words "Obesity", "Menopause", "Herb medicine", "Acupuncture", "Moxibustion", "Catgut embedding" were searched on 9 database systems (PubMed Central, Cochrane Controlled Register of Trials, Embase, China Academic Journals, Korean Traditional Knowledge Portal, Oriental Medicine Advanced Searching Integrated System, Korean Studies Information Service System, National Digital Science Library, DBpia) on April 30th 2019. Results: 1 case report and 17 clinical trials were collected in accordance with the selection and exclusion criteria. Among the 17 trials, 6 were randomized controlled trials, 1 was controlled clinical trial, and 10 were single-arm trials. The types of intervention were herb medicine, electroacupuncture, acupuncture, auricular acupuncture, warm needle acupuncture, moxibustion, laser acupuncture, and catgut embedding. The study design, study results and method of intervention were analyzed. Conclusions: 1 case report described the effectiveness of pharmacopuncture, 4 trials described the effectiveness of herbal medicine, 2 of electroacupuncture, 1 of laser acupuncture, and 2 of catgut embedding. Among the 17 trials, 2 studies showed that herbal medicine treatment was more effective than no treatment or selective serotonin reuptake inhibitors, and 1 study showed that electroacupuncture was more effective than hormone therapy. All of 18 selected studies reported the effectiveness of weight reduction and abdominal obesity reduction after the traditional Korean medicine treatment for obesity in menopausal women.

• 대한한의학회지
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• 제40권1호
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• pp.153-173
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• 2019

Objectives: This study aimed to ascertain what should be considered in the "Guideline for Clinical Trials with Herbal Medicinal Products for Lung Cancer" by analyzing the existing guidelines and clinical trials. Methods: The committee searched guidelines and clinical trials about herbal medicine for lung cancer. The searched trials were analyzed in terms of inclusion and exclusion of participants, intervention, comparator, outcomes and trial design. Then, we compared the results of our analysis with the guidelines to identify the issues we will have to consider when making the "Guideline for Clinical Trials with Herbal Medicinal Products for Lung Cancer". Several guidelines for anti-tumor agents and clinical trials with herbal medicine were searched on the national institution homepage. The search terms were as follows: 'lung neoplasm', 'herbal medicine', 'Medicine, Korean traditional', 'Medicine, Chinese Traditional' etc. Results: There was no guideline for clinical trial with herbal medicine for lung cancer. In addition, 7 articles were searched through database searching. All the participants had non-small cell lung cancer. The type of intervention was decoction. Comparators included conventional treatments such as chemotherapy. The outcome measurements used in the studies were quality of life, tumor response, and survival duration, etc. Safety was evaluated by recording adverse events and blood test. Conclusions: Findings were made by reviewing existing guidelines and comparing them with clinical trials for lung cancer and herbal medicinal products. These results will be utilized in the development of "Guideline for Clinical Trials with Herbal Medicinal Products for Lung Cancer".

• Communications for Statistical Applications and Methods
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• 제24권6호
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• pp.561-581
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• 2017

Bayesian statistics can play a key role in the design and analysis of clinical trials and this has been demonstrated for medical device trials. By 1995 Bayesian statistics had been well developed and the revolution in computing powers and Markov chain Monte Carlo development made calculation of posterior distributions within computational reach. The Food and Drug Administration (FDA) initiative of Bayesian statistics in medical device clinical trials, which began almost 20 years ago, is reviewed in detail along with some of the key decisions that were made along the way. Both Bayesian hierarchical modeling using data from previous studies and Bayesian adaptive designs, usually with a non-informative prior, are discussed. The leveraging of prior study data has been accomplished through Bayesian hierarchical modeling. An enormous advantage of Bayesian adaptive designs is achieved when it is accompanied by modeling of the primary endpoint to produce the predictive posterior distribution. Simulations are crucial to providing the operating characteristics of the Bayesian design, especially for a complex adaptive design. The 2010 FDA Bayesian guidance for medical device trials addressed both approaches as well as exchangeability, Type I error, and sample size. Treatment response adaptive randomization using the famous extracorporeal membrane oxygenation example is discussed. An interesting real example of a Bayesian analysis using a failed trial with an interesting subgroup as prior information is presented. The implications of the likelihood principle are considered. A recent exciting area using Bayesian hierarchical modeling has been the pediatric extrapolation using adult data in clinical trials. Historical control information from previous trials is an underused area that lends itself easily to Bayesian methods. The future including recent trends, decision theoretic trials, Bayesian benefit-risk, virtual patients, and the appalling lack of penetration of Bayesian clinical trials in the medical literature are discussed.

• 한방안이비인후피부과학회지
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• 제15권1호
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• pp.276-284
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• 2002

Aromatherapy is becoming increasingly popular, however there are few clear indications for its use. To systematically review the clinical studies on aromatherapy, computcrized literature searches were performed from PubMed. Fourteen trials were located. The conclusions were as follows: 1. All the trials were published after 1993. 2. To analyze the publication journals, five of fourteen trials were on nursing, three of them on neuropsychiatry and one on dermatology. 3. Most widely used indications of aromatherapy were on general physical, psychological and physiological field. 4. On the procedure of aromatherapy, eight of them were by massage, three by inhalation, one by massage & inhalation and one by bath additive. 5. To analyze the publication type, all fourteen trials were clinical trials. Twelve of them were randomized controlled trials. Two of them were using single subject design. 6. To observe the sample size, five of them were under 10, four from 10 to 50, two from 50 to 100 and three above 100. 7. Eleven of fourteen trials were using inferential statistics. Eight of the eleven trials were significantly effective, but three had no statistical significance.