Open Access Journal of Clinical Trials最新文献

{"title":"The European Medicines Agency Clinical Data Website Enables Insights Into Clinical Development Timelines And Strategy","authors":"S. Lehmann, R. Allard, Y. Boehler","doi":"10.2147/oajct.s205842","DOIUrl":"https://doi.org/10.2147/oajct.s205842","url":null,"abstract":"Sarah Lehmann 1,2 René Allard 2 Yvonne-Beatrice Boehler 1Faculty of Applied Natural Sciences, TH Koeln University of Applied Sciences, Leverkusen, Germany; 2Grünenthal Innovation, Drug Development, Data Sciences’ Grünenthal GmbH, Aachen, Germany Purpose: The clinical study report (CSR) documents of a full clinical development pathway (CDP) have been publicly available on the European Medicines Agency (EMA; Amsterdam, Netherlands) clinical data website (ECDW) since October 2016. Our analysis aimed to determine the extent to which the available clinical development program could be assessed. Methods: The documents available on the ECDW up to April 1, 2018 and the corresponding European Public Assessment Report (EPAR) were reviewed. Information extracted from the available CSRs focused on dates, phase of development, module leaf structure, and number of protocol amendments. Data analyses included generalized activity normalization time table (GANTT) charts and network analyses. Results: Of the 86 available CDPs, 55 were initial marketing authorizations covering a diverse range of clinical developments from generics to advanced therapy in the electronic common technical documents (eCTDs). Non-redacted dates were available in 444 CSRs from 15 CDPs to perform retrospective project clinical development management analyses. In these 15 marketing authorizations, the median timespan to submission was 9.3 years (range: 6.2–22.2). The timespan within these 15 clinical developments ranged from 5.9 to 21.4 years (median 8.3). The median time to first-subject-in in the first controlled clinical study pertinent to the claimed indication (CCSPCI) was 4.4 years (range: 0–12.1); the duration of the CCSPCI ranged from 2.4 to 16.9 years (median: 4.4; interquartile range: 4.2–7.0). Four CDPs had concurrent subject enrolment, while seven CDPs had seamless study designs. Subject participation ranged from 52% to 97% of a clinical development timeline. Conclusion: The publication of CSR documents by the EMA has enabled insights into timelines and project management aspects of the clinical development of medications.","PeriodicalId":19500,"journal":{"name":"Open Access Journal of Clinical Trials","volume":null,"pages":null},"PeriodicalIF":1.2,"publicationDate":"2019-10-15","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://sci-hub-pdf.com/10.2147/oajct.s205842","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"48443780","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}

{"title":"An evaluation of informed consent comprehension by adult trial participants in South Africa at the time of providing consent for clinical trial participation and a review of the literature","authors":"L. Burgess, Berna Gerber, K. Coetzee, Marli Terblanche, Gareth Agar, T. Kotze","doi":"10.2147/OAJCT.S145068","DOIUrl":"https://doi.org/10.2147/OAJCT.S145068","url":null,"abstract":"Lesley Jean Burgess Berna Gerber Kathleen Coetzee Marli Terblanche Gareth Agar Theunis JvW Kotze 1TREAD Research CC, Cardiology Unit, Department of Medicine, Stellenbosch University and Tygerberg Hospital, Parow, South Africa; 2University of Liverpool/Laureate Online Education, Liverpool, UK; 3Division of SpeechLanguage and Hearing Therapy, Faculty of Medicine and Health Sciences, Stellenbosch University Stellenbosch, South Africa Introduction: The informed consent process is a fundamental part of clinical trials and is driven by both a legal and ethical agenda. The process may be seriously compromised if trial participants sign the informed consent document without fully understanding its contents. In developing countries such as South Africa, this concern is important due to the potential vulnerability of these patients and their risk for research exploitation. Aim: To evaluate the understanding of 11 important components and concepts related to clinical research by adult trial participants in a developing country at the time of providing consent for trial participation. Methods: 46 consecutive adult patients who qualified and consented to being enrolled in ongoing cardiovascular risk clinical trials at TREAD Research in the Western Cape, South Africa, were included in this study. After giving informed consent, participants were subjected to both a close-ended (self-report) and an open-ended method (descriptive narrative) to assess their understanding of various components and concepts related to clinical research pertaining to the initial informed consent document. The descriptive narrative was recorded and then later transcribed and assessed by two independent assessors. Results: There was a marked difference between the two methodologies used to assess patient comprehension of the various components. With the exception of concepts voluntariness and right to withdraw, trial participants’ understanding of the informed consent document was poor – especially with regard to the following concepts: randomization, risks, placebo and blinding. Higher levels of comprehension were obtained for the participant selfreports and lower levels for the narrative descriptions. Conclusion: The participant comprehension at this site was poor, and the process for taking informed consent subsequently needs to be modified so as to improve informed consent comprehension.","PeriodicalId":19500,"journal":{"name":"Open Access Journal of Clinical Trials","volume":null,"pages":null},"PeriodicalIF":1.2,"publicationDate":"2019-07-08","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://sci-hub-pdf.com/10.2147/OAJCT.S145068","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"42604090","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}

{"title":"Cost comparison analysis of laparoscopic versus open aortobifemoral bypass surgery: a randomized controlled trial","authors":"M. Sahba, A. H. Krog, E. M. Pettersen, T. Wisløff, Kg Rogne, J. Sundhagen, Ssh Kazmi","doi":"10.2147/OAJCT.S192552","DOIUrl":"https://doi.org/10.2147/OAJCT.S192552","url":null,"abstract":"1Department of Vascular Surgery, Ostfold Central Hospital, Grålum, Norway; 2Department of Vascular Surgery, Sørlandet Hospital HF, Kristiansand, Norway; 3Department of Infectious Disease Epidemiology and Modelling, Norwegian Institute of Public Health, Oslo, Norway; 4Department of Health Management and Health Economics, University of Oslo, Oslo, Norway; 5Economy Department, Oslo University Hospital, Oslo, Norway; 6Department of Vascular Surgery, Division of Cardiovascular and Pulmonary Diseases, Oslo University Hospital, Oslo, Norway; 7Faculty of Medicine, Oslo University, Oslo, Norway Background: Laparoscopic aortobifemoral bypass (LABFB) surgery has become an established treatment procedure for aortoiliac occlusive disease (AIOD), Trans-Atlantic Inter-Society Consensus II (TASC II), type D lesions. However, studies with an economic evaluation of this procedure are sparse. The main purpose of our study was to compare the costs of LABFB and open aortobifemoral bypass (OABFB) surgery. Patients and methods: This is a substudy of a larger randomized controlled prospective multicenter trial, Norwegian Laparoscopic Aortic Surgery Trial (NLAST). Perioperative data were collected on 70 patients undergoing surgery for AIOD, TASC type D lesions. Thirty-four patients were randomized to LABFB and 36 patients to OABFB. Treatment costs were calculated for the two operative treatments until 30 postoperative days. In addition to fixed and variable costs, direct and indirect costs were also included. Results: The mean total cost of LABFB was 19,798 € and for OABFB 34,016 € until 30 postoperative days. Laparoscopic procedure was 14,218 € less costly than the open procedure. The main factor leading to less cost of LABFB was shorter length of hospital stay (mean 5.3 days, 95% CI 4.1–6.5) as compared to OABFB (mean 10.1 days, 95% CI 7.5–12.6). Ten patients, three in the LABFB and seven in the OABFB group, had complications that resulted in reoperations within the 30 postoperative days. The mean cost of treatment for the complicated patients was 49,349 € and 82,985 €, respectively, for LABFB and OABFB. Conclusion: Laparoscopic aortobifemoral bypass procedure costs less than open aortobifemoral bypass for the treatment of advanced aortoiliac occlusive disease.","PeriodicalId":19500,"journal":{"name":"Open Access Journal of Clinical Trials","volume":null,"pages":null},"PeriodicalIF":1.2,"publicationDate":"2019-06-19","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://sci-hub-pdf.com/10.2147/OAJCT.S192552","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"47773913","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}

{"title":"Effects of pain on cognitive function and mobility","authors":"S. A. Moreira, P. Novak","doi":"10.2147/OAJCT.S182502","DOIUrl":"https://doi.org/10.2147/OAJCT.S182502","url":null,"abstract":"php and incorporate the Creative Commons Attribution – Non Commercial (unported, v3.0) License (http://creativecommons.org/licenses/by-nc/3.0/). By accessing the work you hereby accept the Terms. Non-commercial uses of the work are permitted without any further permission from Dove Medical Press Limited, provided the work is properly attributed. For permission for commercial use of this work, please see paragraphs 4.2 and 5 of our Terms (https://www.dovepress.com/terms.php). Open Access Journal of Clinical Trials 2019:11 1–10 Open Access Journal of Clinical Trials Dovepress","PeriodicalId":19500,"journal":{"name":"Open Access Journal of Clinical Trials","volume":null,"pages":null},"PeriodicalIF":1.2,"publicationDate":"2019-03-25","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://sci-hub-pdf.com/10.2147/OAJCT.S182502","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"45484280","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}

{"title":"Selective enhancement of focused attention by Alpinia galanga in subjects with moderate caffeine consumption","authors":"S. Srivastava","doi":"10.2147/OAJCT.S164450","DOIUrl":"https://doi.org/10.2147/OAJCT.S164450","url":null,"abstract":"php and incorporate the Creative Commons Attribution – Non Commercial (unported, v3.0) License (http://creativecommons.org/licenses/by-nc/3.0/). By accessing the work you hereby accept the Terms. Non-commercial uses of the work are permitted without any further permission from Dove Medical Press Limited, provided the work is properly attributed. For permission for commercial use of this work, please see paragraphs 4.2 and 5 of our Terms (https://www.dovepress.com/terms.php). Open Access Journal of Clinical Trials 2018:10 43–49 Open Access Journal of Clinical Trials Dovepress","PeriodicalId":19500,"journal":{"name":"Open Access Journal of Clinical Trials","volume":null,"pages":null},"PeriodicalIF":1.2,"publicationDate":"2018-09-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://sci-hub-pdf.com/10.2147/OAJCT.S164450","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"41308644","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}

{"title":"Placebo-only-controlled versus active-controlled trials of new drugs for nine common life-threatening diseases","authors":"Sarah Sorscher, A. AbuDagga, Sammy Almashat, M. Carome, S. Wolfe","doi":"10.2147/OAJCT.S156054","DOIUrl":"https://doi.org/10.2147/OAJCT.S156054","url":null,"abstract":"php and incorporate the Creative Commons Attribution – Non Commercial (unported, v3.0) License (http://creativecommons.org/licenses/by-nc/3.0/). By accessing the work you hereby accept the Terms. Non-commercial uses of the work are permitted without any further permission from Dove Medical Press Limited, provided the work is properly attributed. For permission for commercial use of this work, please see paragraphs 4.2 and 5 of our Terms (https://www.dovepress.com/terms.php). Open Access Journal of Clinical Trials 2018:10 19–28 Open Access Journal of Clinical Trials Dovepress","PeriodicalId":19500,"journal":{"name":"Open Access Journal of Clinical Trials","volume":null,"pages":null},"PeriodicalIF":1.2,"publicationDate":"2018-04-24","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://sci-hub-pdf.com/10.2147/OAJCT.S156054","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"47298153","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}

{"title":"Open-label Phase II study of everolimus plus endocrine therapy in postmenopausal women with ER-positive and HER2-negative metastatic breast cancer (Chloe trial)","authors":"T. Shimoi, A. Shimomura, T. Shien, Y. Uemura, H. Kato, M. Kitada, T. Toyama, T. Aihara, H. Mukai","doi":"10.2147/OAJCT.S155706","DOIUrl":"https://doi.org/10.2147/OAJCT.S155706","url":null,"abstract":"Background: This is a randomized, multicenter, open-label, Phase II study designed to evaluate the efficacy of everolimus added to continuous aromatase inhibitor (AI) administration in patients who had maintained stable disease or a better response for at least 5 months. Patients and methods: Patients will be randomized to everolimus and standard therapy groups (1:1 ratio). In the everolimus group, patients will receive everolimus in addition to the AI agent. The standard therapy group will continue AI alone treatment. The primary endpoint is progression-free survival. Target accrual is 130 patients with a two-sided type I error rate of 10% and 80% power to detect 35% risk reduction. Conclusion: The Chloe trial will provide important information about the efficacy and safety of adding everolimus to AI in patients with estrogen receptor-positive and human epidermal growth factor 2-negative metastatic breast cancer.","PeriodicalId":19500,"journal":{"name":"Open Access Journal of Clinical Trials","volume":null,"pages":null},"PeriodicalIF":1.2,"publicationDate":"2018-02-16","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://sci-hub-pdf.com/10.2147/OAJCT.S155706","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"46389454","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}

{"title":"Computerized Cognitive Training to Improve Mood in Senior Living Settings: Design of a Randomized Controlled Trial.","authors":"Marianne Smith,&nbsp;Michael P Jones,&nbsp;Megan M Dotson,&nbsp;Fredric D Wolinsky","doi":"10.2147/OAJCT.S154782","DOIUrl":"https://doi.org/10.2147/OAJCT.S154782","url":null,"abstract":"<p><strong>Purpose: </strong>This two-arm, randomized controlled trial was designed to evaluate a computerized cognitive speed of processing (SOP) training known as <i>Road Tour</i> in the generally older group of adults residing in assisted living (AL) and related senior housing. Study aims focused on depression-related outcomes that were observed in earlier SOP studies using <i>Road Tour</i> with younger, home-dwelling seniors. Study design and baseline outcomes are discussed.</p><p><strong>Participants and methods: </strong>A community-based design engaged AL and related senior living settings as partners in research. Selected staff served as on-site research assistants who were trained to recruit, consent, and train a target of 300 participants from AL and independent living (IL) programs to use the intervention and attention-control computerized training. Ten hours of initial computerized training was followed by two booster sessions at 5 and 11 months. Outcome measures included Useful Field of View (UFOV), 9-item Patient Health Questionnaire (PHQ-9), 12-item Centers for Epidemiological Studies Depression scale (CESD-12), 7-item Generalized Anxiety Disorders GAD-7), Brief Pain Inventory (BPI) and SF-36 Health Survey. Assessments occurred before randomization (pre-training), post-training, 26 and 52 weeks.</p><p><strong>Results: </strong>A total of 351 participants were randomized to the intervention (n=173) and attention-control (n=178) groups. There were no significant differences between groups in demographic characteristics with the exception of education and reported osteoporosis. There were no significant differences in study outcomes between groups at baseline. Participants in AL had significantly lower SOP and self-rated health, and significantly higher depression, anxiety and pain when compared to those in IL programs on the same campus.</p><p><strong>Conclusions: </strong>Compared to earlier SOP training studies using <i>Road Tour</i>, this sample of senior living participants were older, reported more health conditions and poorer overall health, had lower UFOV scores and greater depressive symptoms at baseline. Moreover, participants in AL had greater health challenges than those in IL.</p>","PeriodicalId":19500,"journal":{"name":"Open Access Journal of Clinical Trials","volume":null,"pages":null},"PeriodicalIF":1.2,"publicationDate":"2018-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://sci-hub-pdf.com/10.2147/OAJCT.S154782","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"37422026","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Life Enhancing Activities for Family Caregivers of people with dementia: protocol for a randomized controlled trial of a positive affect skills intervention.","authors":"Alice Verstaen,&nbsp;Judith T Moskowitz,&nbsp;Karin E Snowberg,&nbsp;Jennifer Merrilees,&nbsp;Glenna A Dowling","doi":"10.2147/oajct.s150597","DOIUrl":"https://doi.org/10.2147/oajct.s150597","url":null,"abstract":"<p><p>Given the increasing number of family caregivers of persons with dementia (PWD) and the associated burden and detriments to both physical and mental health, interventions that aim to improve such outcomes are important. Studies are increasingly demonstrating the unique importance of positive emotions in coping with stress, independent from the impact of negative emotions. However, none have examined the benefits of interventions that target positive emotions for caregivers of individuals with a chronic and debilitating disease such as dementia. This paper presents the design and methods for a randomized controlled trial (RCT) of a positive affect skills intervention for family caregivers of PWD. The RCT is of a skills-based intervention that seeks to increase the frequency and intensity of positive affect in order to improve outcomes such as well-being, coping, and physical and mental health. The skills are delivered by trained facilitators via five one-to-one Internet video sessions with family caregivers of persons diagnosed with dementia (eg, Alzheimer's disease, vascular dementia, unspecified). The control group is an emotion reporting/waitlist control. Follow-up assessments are conducted post-intervention and at 1, 3, and 6 months post-completion of the intervention. This study promises to be an important and needed step toward improving the lives of caregivers of PWD.</p>","PeriodicalId":19500,"journal":{"name":"Open Access Journal of Clinical Trials","volume":null,"pages":null},"PeriodicalIF":1.2,"publicationDate":"2018-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://sci-hub-pdf.com/10.2147/oajct.s150597","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"38976078","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Randomized response surface pathway design with odd response outcomes in a Latin Square designed study","authors":"T. Holand, K. Ellingsen, Sagita Dewi, S. Larsen","doi":"10.2147/OAJCT.S139884","DOIUrl":"https://doi.org/10.2147/OAJCT.S139884","url":null,"abstract":"php and incorporate the Creative Commons Attribution – Non Commercial (unported, v3.0) License (http://creativecommons.org/licenses/by-nc/3.0/). By accessing the work you hereby accept the Terms. Non-commercial uses of the work are permitted without any further permission from Dove Medical Press Limited, provided the work is properly attributed. For permission for commercial use of this work, please see paragraphs 4.2 and 5 of our Terms (https://www.dovepress.com/terms.php). Open Access Journal of Clinical Trials 2017:9 75–84 Open Access Journal of Clinical Trials Dovepress","PeriodicalId":19500,"journal":{"name":"Open Access Journal of Clinical Trials","volume":null,"pages":null},"PeriodicalIF":1.2,"publicationDate":"2017-09-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://sci-hub-pdf.com/10.2147/OAJCT.S139884","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"48396013","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}