Clinical Trials and Practice – Open Journal最新文献_第3页

Latest Results from Immunotherapy Clinical Trials in Triple Negative Breast Cancer 三阴性乳腺癌免疫治疗临床试验的最新结果

Clinical Trials and Practice – Open Journal Pub Date : 2019-12-31 DOI: 10.17140/ctpoj-2-105

A. Strimpakos, K. Tsigaridas, M. Avgoustidou

引用次数: 0

Clinical Research: The Future of Medicine Stuck in the Digital Past 临床研究:医学的未来停留在数字化的过去

Clinical Trials and Practice – Open Journal Pub Date : 2019-12-31 DOI: 10.17140/ctpoj-2-107

Elizabeth Del Mastro Benincasa

引用次数: 0

Cluster Randomized Controlled Trials: A Quick Update on Concepts and Types 聚类随机对照试验:概念和类型的快速更新

Clinical Trials and Practice – Open Journal Pub Date : 2017-12-31 DOI: 10.17140/ctpoj-1-103

B. Egbewale

引用次数: 0

Clinical Investigations on Medical Devices, after the New European Regulation (2017/745) 在欧洲新法规(2017/745)之后，医疗器械的临床调查

Clinical Trials and Practice – Open Journal Pub Date : 2017-12-31 DOI: 10.17140/ctpoj-1-102

S. Bianco, A. Nunziata, G. Pozzoli

{"title":"Clinical Investigations on Medical Devices, after the New European Regulation (2017/745)","authors":"S. Bianco, A. Nunziata, G. Pozzoli","doi":"10.17140/ctpoj-1-102","DOIUrl":"https://doi.org/10.17140/ctpoj-1-102","url":null,"abstract":"Medical devices (MDs) include different products and their importance in the healthcare industry is truly remarkable. The recently issued Regulation 2017/745 (Reg. 2017/745) introduced several major changes concerning planning, conducting and reporting of clinical investigations (CIs). Manufacturers and independent researchers would have to adapt quickly to this complex regulation, as the transition period from the previous regulations to the new one would last only three years. The present study having analysed Reg. 2017/745, provides a reference guide for researchers willing to conduct a CI. In particular, this study focused on six aspects of practical interest: (1) significance of CIs in the clinical evaluation of MDs, (2) aims of a CI, (3) cases where a CI is mandatory and exceptions to this rule, (4) application procedure for a CI, (5) requirements for conducting CI, (6) serious adverse events (AE) reporting (7), CI results. The regulations governing CI are influenced by different international, national and regional laws and guidelines. The aim of the paper is to create awareness among the readers about complex regulations and provide the readers a reference to the EU regulations. In addition to that, the authors stress on some issues that they consider to be of particular importance. Even though this paper does not serve as a substitute or replacement of the regulation; it acts as a guide for the reference of the readers with respect to the EU, national and local regulations. The authors conclude that the design and conducting of CIs demands that the personnel in charge have the relevant training and expertise in the field of MDs.","PeriodicalId":259842,"journal":{"name":"Clinical Trials and Practice – Open Journal","volume":"210 1","pages":"0"},"PeriodicalIF":0.0,"publicationDate":"2017-12-31","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"133494990","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

引用次数: 5

Model Based vs. Rule Based Designs in Phase I Dose Finding Clinical Trials 基于模型与基于规则的I期剂量寻找临床试验设计

Clinical Trials and Practice – Open Journal Pub Date : 2017-12-31 DOI: 10.17140/ctpoj-1-e001

Yunfei Wang, Jichuan Wang

引用次数: 1

Distribution and Conduct of Clinical Trials Involving Music Therapy: Registered Clinical Trials in the Last 15 Years 音乐治疗临床试验的分布与实施:近15年的注册临床试验

Clinical Trials and Practice – Open Journal Pub Date : 2017-12-31 DOI: 10.17140/ctpoj-1-101

K. Yukawa, H. Fuji, H. Sato

{"title":"Distribution and Conduct of Clinical Trials Involving Music Therapy: Registered Clinical Trials in the Last 15 Years","authors":"K. Yukawa, H. Fuji, H. Sato","doi":"10.17140/ctpoj-1-101","DOIUrl":"https://doi.org/10.17140/ctpoj-1-101","url":null,"abstract":"Objective: This study aimed to conduct an evaluation of music therapy clinical trials worldwide, to understand what trials have been conducted and to show the chronological changes. Additionally, we sought to clarify issues related to providing clinical trial registration information. Methods: We searched the International Clinical Trials Registry Platform (ICTRP) database for “music therapy,” and identified the disease target for each article found. Results: A total of 150 clinical trial studies were found in the ICTRP using the term “music therapy.” In these trials, music therapy was used for improvement of social functioning in schizophrenia and/or serious mental disorders, anxiety and depressive symptoms, and cancer symptoms. Twenty-five clinical trials were actively recruiting. Sixteen of the 25 trials were registered in the United States at ClinicalTrials.gov, of which 9 trials were conducted in the US. Seven trials were conducted in other countries such as Spain, Taiwan, and China. Conclusion: A search for music therapy clinical trials retrieved 150 trials from the ICTRP, and the number of clinical trial registrations has increased yearly. Music therapy is widely used in patients with various diseases, including Alzheimer’s disease, anxiety, and arthritic pain and has the potential to improve certain disease outcomes, but there is not enough evidence to substantiate its efficacy. It is important to enlighten researchers and pharmaceutical companies on the proper management of the quality of such clinical trial information, as this is an important issue.","PeriodicalId":259842,"journal":{"name":"Clinical Trials and Practice – Open Journal","volume":"630 1","pages":"0"},"PeriodicalIF":0.0,"publicationDate":"2017-12-31","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"116408094","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

引用次数: 0