Open Access Journal of Clinical Trials最新文献

{"title":"Analyzing noninferiority trials: it is time for advantage deficit assessment – an observational study of published noninferiority trials","authors":"B. Gladstone, W. Vach","doi":"10.2147/OAJCT.S74821","DOIUrl":"https://doi.org/10.2147/OAJCT.S74821","url":null,"abstract":"License. The full terms of the License are available at http://creativecommons.org/licenses/by-nc/3.0/. Non-commercial uses of the work are permitted without any further permission from Dove Medical Press Limited, provided the work is properly attributed. Permissions beyond the scope of the License are administered by Dove Medical Press Limited. Information on how to request permission may be found at: http://www.dovepress.com/permissions.php Open Access Journal of Clinical Trials 2015:7 11–21 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":"2015-01-27","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://sci-hub-pdf.com/10.2147/OAJCT.S74821","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"68415569","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":"Lessons learnt from implementing an empirically informed recruitment approach for FEM-PrEP, a large HIV prevention clinical trial","authors":"Caleb Parker, A. Corneli, K. Agot, Jacob Odhiambo, Jesse Asewe, Khatija Ahmed, Joseph Skhosana, Malebo Ratlhagana, Michele Lanham, Christina Wong, J. Deese, Rachel Manongi, L. Damme","doi":"10.2147/OAJCT.S68229","DOIUrl":"https://doi.org/10.2147/OAJCT.S68229","url":null,"abstract":": We implemented an empirically informed, geographically based recruitment approach for FEM-PrEP, a human immunodeficiency virus (HIV) prevention clinical trial of daily oral emtricitabine (FTC) and tenofovir disoproxil fumarate (TDF) for HIV prevention. During the formative research phase, we conducted a modification of the Priorities for Local AIDS Control Efforts (PLACE) method and used those data and staff experiences to identify and prioritize for recruitment geographic areas where HIV incidence might be high. During the clinical trial, we implemented a routinely monitored and flexible recruitment plan in the geographical areas identified in the formative research. We describe three lessons learnt from implementing this approach: 1) the PLACE data were critical in identifying places presumed to be high risk; 2) staff experiences, in combination with PLACE data, were needed to inform a practical recruitment strategy; and 3) recruiting in establishments in priority areas identified by the PLACE data led to screening many HIV-positive women at the Bondo site (Kenya), placing additional burden on clinic staff. These lessons learnt highlight the critical importance of having a flexible and monitored recruitment strategy. Although we successfully recruited a study population at higher risk for HIV, FEM-PrEP was unable to determine the effectiveness of FTC/TDF for HIV prevention, due to low adherence to the study product among participants. We must shift the paradigm of recruitment for clinical trials of new products from focusing on identifying populations with high incidence to identifying populations at risk who are motivated and able to adhere to the study product regimen.","PeriodicalId":19500,"journal":{"name":"Open Access Journal of Clinical Trials","volume":null,"pages":null},"PeriodicalIF":1.2,"publicationDate":"2014-12-19","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://sci-hub-pdf.com/10.2147/OAJCT.S68229","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"68415171","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":"Pediatric clinical trials: a US perspective","authors":"M. Oelstrom, Margo L Hoover-Regan","doi":"10.2147/OAJCT.S48506","DOIUrl":"https://doi.org/10.2147/OAJCT.S48506","url":null,"abstract":"(unported, v3.0) License. The full terms of the License are available at http://creativecommons.org/licenses/by-nc/3.0/. Non-commercial uses of the work are permitted without any further permission from Dove Medical Press Limited, provided the work is properly attributed. Permissions beyond the scope of the License are administered by Dove Medical Press Limited. Information on how to request permission may be found at: http://www.dovepress.com/permissions.php Open Access Journal of Clinical Trials 2014:6 127–138 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":"2014-11-26","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://sci-hub-pdf.com/10.2147/OAJCT.S48506","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"68414327","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":"Randomized controlled trial to evaluate the effect of canola oil on blood vessel function in peripheral arterial disease: rationale and design of the Canola-PAD Study","authors":"J. Enns, P. Zahradka, Randolph P Guzman, Alanna Baldwin, Brendon Foot, Carla G. Taylor","doi":"10.2147/OAJCT.S70576","DOIUrl":"https://doi.org/10.2147/OAJCT.S70576","url":null,"abstract":"License. The full terms of the License are available at http://creativecommons.org/licenses/by-nc/3.0/. Non-commercial uses of the work are permitted without any further permission from Dove Medical Press Limited, provided the work is properly attributed. Permissions beyond the scope of the License are administered by Dove Medical Press Limited. Information on how to request permission may be found at: http://www.dovepress.com/permissions.php Open Access Journal of Clinical Trials 2014:6 117–125 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":"2014-10-25","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://sci-hub-pdf.com/10.2147/OAJCT.S70576","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"68415352","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":"A gender-medicine post hoc analysis (MetaGeM) project to test sex differences in previous observational studies in different diseases: methodology","authors":"D. Colombo, G. Bellia, D. Vassellatti, E. Zagni, S. Sgarbi, S. Rizzoli","doi":"10.2147/OAJCT.S67914","DOIUrl":"https://doi.org/10.2147/OAJCT.S67914","url":null,"abstract":"Only recently has medical research begun to understand the importance of taking sex into account, recognizing that symptoms and responses to medical treatment may be very different between males and females. However, the analyses provided by the pharmaceutical industry to regulatory authorities often do not present safety and efficacy data by sex. Novartis has started a gender-medicine project called MetaGeM, which includes nine observational studies sponsored by Novartis Farma, Italy; conducted in Italy between 2002 and 2013 in a range of different clinical areas. The MetaGeM project aims to analyze and describe by means of post hoc analyses and meta-analyses, clinical outcomes, therapeutic approaches, and safety data of these studies, by sex: PSYCHAE; GENDER ATTENTION in psoriasis; Synergy in psoriatic arthritis; ICEBERG in HBsAg carriers; SURF and CETRA in liverand renal transplanted patients, respectively; DEEP in Parkinson’s disease; and EVOLUTION and AXEPT in Alzheimer’s disease. The present paper describes the methodology of the MetaGeM project.","PeriodicalId":19500,"journal":{"name":"Open Access Journal of Clinical Trials","volume":null,"pages":null},"PeriodicalIF":1.2,"publicationDate":"2014-10-13","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://sci-hub-pdf.com/10.2147/OAJCT.S67914","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"68415116","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":"Clinical trial design in the era of comparative effectiveness research","authors":"Anke C. Winter, G. Colditz","doi":"10.2147/OAJCT.S39758","DOIUrl":"https://doi.org/10.2147/OAJCT.S39758","url":null,"abstract":": Clinical trials are one of the key study designs in the evolving field of comparative effectiveness research. Evaluating the effectiveness of interventions in real-world settings is complex and demands a rethinking of the traditional clinical trial approach as well as transformation of the clinical trial landscape. Novel strategies and refinement of existing approaches have been proposed to generate evidence that can guide health care stakeholders in their decision process. The purpose of this review is to discuss clinical trial design approaches in the era of comparative effectiveness research. We will focus on aspects relevant to the type of clinical trial, study population and recruitment, randomization process, outcome measures, and data collection.","PeriodicalId":19500,"journal":{"name":"Open Access Journal of Clinical Trials","volume":null,"pages":null},"PeriodicalIF":1.2,"publicationDate":"2014-10-03","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://sci-hub-pdf.com/10.2147/OAJCT.S39758","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"68414058","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":"Randomized controlled trial of a positive affect intervention to reduce stress in people newly diagnosed with HIV; protocol and design for the IRISS study","authors":"J. Moskowitz, A. Carrico, M. Cohn, Larissa G. Duncan, Cori Bussolari, Kristin Layous, J. Hult, A. Brousset, P. Cotten, Stephanie Maurer, Martha Pietrucha, M. Acree, J. Wrubel, Mallory O. Johnson, F. Hecht, S. Folkman","doi":"10.2147/OAJCT.S64645","DOIUrl":"https://doi.org/10.2147/OAJCT.S64645","url":null,"abstract":"License. The full terms of the License are available at http://creativecommons.org/licenses/by-nc/3.0/. Non-commercial uses of the work are permitted without any further permission from Dove Medical Press Limited, provided the work is properly attributed. Permissions beyond the scope of the License are administered by Dove Medical Press Limited. Information on how to request permission may be found at: http://www.dovepress.com/permissions.php Open Access Journal of Clinical Trials 2014:6 85–100 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":"2014-09-22","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://sci-hub-pdf.com/10.2147/OAJCT.S64645","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"68415085","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":"Evolution of the clinical trial landscape in Asia Pacific","authors":"Shourav. Yathindranath, A. Kureishi, Simranjit Singh, Spencer Yeow, G. Geng, K. Wai, Audrey Ho, Elvira Zenaida Lansang, Ken J Lee","doi":"10.2147/OAJCT.S57060","DOIUrl":"https://doi.org/10.2147/OAJCT.S57060","url":null,"abstract":"License. The full terms of the License are available at http://creativecommons.org/licenses/by-nc/3.0/. Non-commercial uses of the work are permitted without any further permission from Dove Medical Press Limited, provided the work is properly attributed. Permissions beyond the scope of the License are administered by Dove Medical Press Limited. Information on how to request permission may be found at: http://www.dovepress.com/permissions.php Open Access Journal of Clinical Trials 2014:6 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":"2014-07-29","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://sci-hub-pdf.com/10.2147/OAJCT.S57060","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"68414862","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":"Between- and within-patient n -level response surface pathway design in dose-finding studies","authors":"Sagita Dewi, Veronica Kristiansen, S. lindkær-Jensen, S. Larsen","doi":"10.2147/OAJCT.S57955","DOIUrl":"https://doi.org/10.2147/OAJCT.S57955","url":null,"abstract":"Background: The most commonly used escalation methods in dose-finding studies have obvious weaknesses, and the Bayesian approach is difficult for clinicians to understand and to apply. The study aims were to introduce and assess the performance of clinically based response surface pathway (RSP) design for dose-finding studies, exemplified by one between-patient study, one within-patient study, and simulation studies. Methods: The between-patient study consisted of 15 women suffering from stage IV breast cancer, while the within-patient study consisted of seven female dogs with metastatic mammary cancer. The studies were conducted to determine the maximum tolerated dose (MTD) of a new anticancer agent named BP-C1 using three-level RSP designs. Adjustment of the dose from one design level to the next was based on a k -adjustment factor estimated to ensure coverage of the entire predefined dose window. Patient sequences with an equal number of patients as design levels were included in the between-patient design, whereas the same patients were included in all the design levels in the within-patient design. Results: Four of the five patient sequences in the between-patient study and all seven dogs in the within-patient study reached the upper limit of the dose windows without any increase in toxicity. The MTD of BP-C1 was thus found to be higher than the predefined cumulative dose window for both patient groups. In all three scenarios, the RSP design estimated MTDs better than the traditional 3 + 3 design; however, the toxicity rates were found to be higher when the target MTD was under the starting dose. Conclusion: The RSP designs do not need an assumed statistical model, and may be useful in estimating MTD, using a minimal sample size. The k -adjustment factor ensures complete dose window coverage and the design utilizes more information by allowing multinomial outcomes. Phase I studies are conducted sequentially, allocating dose levels to patients based on the observed toxicity effect from previous patients or treatment periods.","PeriodicalId":19500,"journal":{"name":"Open Access Journal of Clinical Trials","volume":null,"pages":null},"PeriodicalIF":1.2,"publicationDate":"2014-07-03","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://sci-hub-pdf.com/10.2147/OAJCT.S57955","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"68414935","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":"Safety and tolerability of an intravenously administered alpha1-proteinase inhibitor at an increased infusion rate: a novel, randomized, placebo-masked, infusion rate-controlled, crossover study in healthy adults","authors":"L. Ngo, A. Haeberle, J. Dyck-Jones, D. Gelmont, L. Yel","doi":"10.2147/OAJCT.S62754","DOIUrl":"https://doi.org/10.2147/OAJCT.S62754","url":null,"abstract":"License. The full terms of the License are available at http://creativecommons.org/licenses/by-nc/3.0/. Non-commercial uses of the work are permitted without any further permission from Dove Medical Press Limited, provided the work is properly attributed. Permissions beyond the scope of the License are administered by Dove Medical Press Limited. Information on how to request permission may be found at: http://www.dovepress.com/permissions.php Open Access Journal of Clinical Trials 2014:6 55–61 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":"2014-06-23","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://sci-hub-pdf.com/10.2147/OAJCT.S62754","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"68414778","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}