Open Access Journal of Clinical Trials最新文献_第5页

Protocol-writing support conferences for investigator-initiated clinical trials 为研究者发起的临床试验编写协议支持会议

IF 1.2

Open Access Journal of Clinical Trials Pub Date : 2016-04-12 DOI: 10.2147/OAJCT.S97792

Masaya Goto, Y. Muragaki, A. Aruga

{"title":"Protocol-writing support conferences for investigator-initiated clinical trials","authors":"Masaya Goto, Y. Muragaki, A. Aruga","doi":"10.2147/OAJCT.S97792","DOIUrl":"https://doi.org/10.2147/OAJCT.S97792","url":null,"abstract":": In investigator-initiated clinical trials, protocols with inappropriate methods might cause bias. However, insufficient data are available to determine which items are important or difficult to discuss in protocol development. We recorded protocol-writing support conferences to determine what items methodologists and investigators discussed. We obtained approval from all applicants to attend our Intelligent Clinical Research and Innovation Center writing support conferences, recorded all the discussions, characterized them, and sorted the items iteratively. In 1 year, we had 18 conferences: nine early protocol conferences and nine rejected protocol conferences. The latter were rejected by the institutional review board, which requested consultation. The most discussed item was outcomes, accounting for ∼ 20% of the total discussion time. In three trials, the main problem was multiple primary outcomes. The second most discussed item was control. Early protocol conferences had more non-preliminary proposal items than rejected ones ( P , 0.001). This study showed important items (especially outcomes and control) for investigators to write protocols. Early protocol-writing conferences helped investigators find questionable items.","PeriodicalId":19500,"journal":{"name":"Open Access Journal of Clinical Trials","volume":"8 1","pages":"7-12"},"PeriodicalIF":1.2,"publicationDate":"2016-04-12","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://sci-hub-pdf.com/10.2147/OAJCT.S97792","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"68418773","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

Neuropsychiatric symptoms in dementia and the effects of Ginkgo biloba extract EGb 761 ® treatment: additional results from a 24-week randomized, placebo-controlled trial 痴呆的神经精神症状和银杏叶提取物EGb 761®治疗的效果:来自24周随机、安慰剂对照试验的额外结果

IF 1.2

Open Access Journal of Clinical Trials Pub Date : 2016-01-18 DOI: 10.2147/OAJCT.S93531

Anatol Nacu, R. Hoerr

{"title":"Neuropsychiatric symptoms in dementia and the effects of Ginkgo biloba extract EGb 761 ® treatment: additional results from a 24-week randomized, placebo-controlled trial","authors":"Anatol Nacu, R. Hoerr","doi":"10.2147/OAJCT.S93531","DOIUrl":"https://doi.org/10.2147/OAJCT.S93531","url":null,"abstract":"EGb 761 ® on specific neuropsychiatric symptoms. In a 24-week, double-blind, multi-center trial, 410 outpatients with mild to moderate dementia and clinically significant neuropsychiatric symptoms were enrolled and randomized to receive 240 mg/day EGb 761 ® or placebo. The Neuropsychiatric Inventory composite score and the SKT short cognitive performance test were prospectively defined as co-primary outcomes; caregiver distress scores and single item scores were prospectively defined as secondary outcomes. Results: Post-baseline efficacy data were available for 402 patients included in the full analysis set. Neuropsychiatric Inventory composite and caregiver distress scores improved significantly more under EGb 761 ® treatment than under placebo ( P , 0.001). Composite and caregiver distress scores of anxiety, apathy, and disturbances of sleep and nighttime behavior, as well as caregiver distress scores of depression and aberrant motor behavior, were improved most markedly by EGb 761 ® ( P , 0.05 vs placebo). Conclusion: EGb 761 ® at daily doses of 240 mg alleviated neuropsychiatric symptoms of dementia and reduced related caregiver distress.","PeriodicalId":19500,"journal":{"name":"Open Access Journal of Clinical Trials","volume":"8 1","pages":"1-6"},"PeriodicalIF":1.2,"publicationDate":"2016-01-18","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://sci-hub-pdf.com/10.2147/OAJCT.S93531","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"68418659","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: 15

A televideo exercise and nutrition program for children with acute lymphoblastic leukemia in maintenance therapy: design and methods 急性淋巴细胞白血病儿童维持治疗的电视运动和营养计划:设计和方法

IF 1.2

Open Access Journal of Clinical Trials Pub Date : 2015-07-29 DOI: 10.2147/OAJCT.S83292

C. Gibson, K. August, J. L. Greene, S. Herrmann, Jaehoon Lee, Susan P Harvey, Kate Lambourne, D. Sullivan

引用次数: 4

Deep brain stimulation targeting the fornix for mild Alzheimer dementia: design of the ADvance randomized controlled trial 针对穹窿的深部脑刺激治疗轻度阿尔茨海默病:ADvance随机对照试验的设计

IF 1.2

Open Access Journal of Clinical Trials Pub Date : 2015-07-10 DOI: 10.2147/OAJCT.S81542

K. Holroyd, L. Fosdick, Gwenn S. Smith, Jeannie-Marie S Leoutsakos, C. Munro, E. Oh, Kristen E. Drake, P. Rosenberg, W. Anderson, S. Salloway, J. Pendergrass, A. Burke, D. Wolk, D. Tang‐Wai, F. Ponce, Wael Asaad, M. Sabbagh, M. Okun, G. Baltuch, K. Foote, S. Targum, A. Lozano, C. Lyketsos

引用次数: 14

Design, and participant enrollment, of a randomized controlled trial evaluating effectiveness and cost-effectiveness of a community-based case management intervention, for patients suffering from COPD 设计一项随机对照试验，评估社区病例管理干预对慢性阻塞性肺病患者的有效性和成本效益

IF 1.2

Open Access Journal of Clinical Trials Pub Date : 2015-06-18 DOI: 10.2147/OAJCT.S82533

S. S. Sørensen, K. M. Pedersen, U. Weinreich, L. Ehlers

引用次数: 11

On controversial statistical issues in clinical research 关于临床研究中有争议的统计问题

IF 1.2

Open Access Journal of Clinical Trials Pub Date : 2015-05-02 DOI: 10.2147/OAJCT.S63266

S. Chow, Fuyu Song

{"title":"On controversial statistical issues in clinical research","authors":"S. Chow, Fuyu Song","doi":"10.2147/OAJCT.S63266","DOIUrl":"https://doi.org/10.2147/OAJCT.S63266","url":null,"abstract":"In clinical development of a test treatment under investigation, clinical trials are often conducted for evaluation of safety and efficacy of the test treatment. To provide an accurate and reliable assessment, adequate and well-controlled clinical trials using valid study designs are necessarily conducted for obtaining substantial evidence of safety and efficacy of the test treat - ment under investigation. In practice, however, some debatable issues are commonly encountered regardless compliance with good statistics practice and good clinical practice. These issues include, but are not limited to: 1) appropriateness of statistical hypotheses for clinical investiga- tion; 2) correctness of power analysis assumptions; 3) integrity of randomization and blinding; 4) post hoc endpoint selection; 5) impact of protocol amendments on the characteristics of the trial population; 6) multiplicity in clinical trials; 7) missing data imputation; 8) adaptive design methods; and 9) independence of a data monitoring committee. In this article, these issues are briefly described. The impact of these issues on the evaluation of the safety and efficacy of the test treatment under investigation are discussed with examples whenever applicable. Some recommendations regarding possible resolutions of these issues are also provided.","PeriodicalId":19500,"journal":{"name":"Open Access Journal of Clinical Trials","volume":"7 1","pages":"43-51"},"PeriodicalIF":1.2,"publicationDate":"2015-05-02","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://sci-hub-pdf.com/10.2147/OAJCT.S63266","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"68414965","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: 1

Effect of GenF20 Plus on serum IGF-1 levels in healthy adults: a randomized controlled study GenF20 Plus对健康成人血清IGF-1水平的影响:一项随机对照研究

IF 1.2

Open Access Journal of Clinical Trials Pub Date : 2015-03-25 DOI: 10.2147/OAJCT.S75969

Navneet Sonawane, V. Kale, S. Erande, J. Chaudhary

引用次数: 1

Conducting clinical trials in emerging markets of sub-Saharan Africa: review of guidelines and resources for foreign sponsors 在撒哈拉以南非洲新兴市场开展临床试验:审查外国赞助商的指导方针和资源

IF 1.2

Open Access Journal of Clinical Trials Pub Date : 2015-03-24 DOI: 10.2147/OAJCT.S77316

Gaurav Puppalwar, M. Mourya, G. Kadhe, A. Mane

引用次数: 22

Analyzing noninferiority trials: it is time for advantage deficit assessment – an observational study of published noninferiority trials 分析非劣效性试验:是时候进行优势缺陷评估了——一项对已发表的非劣效性试验的观察性研究

IF 1.2

Open Access Journal of Clinical Trials Pub Date : 2015-01-27 DOI: 10.2147/OAJCT.S74821

B. Gladstone, W. Vach

引用次数: 6

Lessons learnt from implementing an empirically informed recruitment approach for FEM-PrEP, a large HIV prevention clinical trial 在大型艾滋病毒预防临床试验FEM-PrEP中实施经验知情的招募方法的经验教训

IF 1.2

Open Access Journal of Clinical Trials Pub Date : 2014-12-19 DOI: 10.2147/OAJCT.S68229

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

{"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":"7 1","pages":"1-9"},"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}

引用次数: 1