: 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.
{"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}
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.
{"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}
C. Gibson, K. August, J. L. Greene, S. Herrmann, Jaehoon Lee, Susan P Harvey, Kate Lambourne, D. Sullivan
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 77–84 Open Access Journal of Clinical Trials Dovepress
许可证。许可的完整条款可在http://creativecommons.org/licenses/by-nc/3.0/上获得。允许非商业用途的工作，没有任何进一步的许可，从多芬医学出版社有限公司，只要工作适当署名。超出许可范围的许可由多芬医疗新闻有限公司管理。有关如何请求许可的信息可在以下网站找到:http://www.dovepress.com/permissions.php Open Access Journal of Clinical Trials 2015:7 77-84 Open Access Journal of Clinical Trials Dovepress
{"title":"A televideo exercise and nutrition program for children with acute lymphoblastic leukemia in maintenance therapy: design and methods","authors":"C. Gibson, K. August, J. L. Greene, S. Herrmann, Jaehoon Lee, Susan P Harvey, Kate Lambourne, D. Sullivan","doi":"10.2147/OAJCT.S83292","DOIUrl":"https://doi.org/10.2147/OAJCT.S83292","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 77–84 Open Access Journal of Clinical Trials Dovepress","PeriodicalId":19500,"journal":{"name":"Open Access Journal of Clinical Trials","volume":"7 1","pages":"77-84"},"PeriodicalIF":1.2,"publicationDate":"2015-07-29","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://sci-hub-pdf.com/10.2147/OAJCT.S83292","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"68418843","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}
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
Recommended Citation Holroyd, Kathryn B.; Fosdick, Lisa; Smith, Gwenn S.; Leoutsakos, Jeannie Marie; Munro, Cynthia A.; Oh, Esther S.; Drake, Kristen E.; Rosenberg, Paul B.; Anderson, William S.; Salloway, Stephen; Pendergrass, J. Cara; Burke, Anna D.; Wolk, David A.; Tang-Wai, David F.; Ponce, Francisco A.; Asaad, Wael F.; Sabbagh, Marwan N.; Okun, Michael S.; Baltuch, Gordon; and al., et, "Deep Brain Stimulation Targeting the Fornix for Mild Alzheimer Dementia: Design of the ADvance Randomized Controlled Trial" (2015). Neurology Articles. 30. https://scholar.barrowneuro.org/neurology/30
霍罗伊德，凯瑟琳B.;Fosdick,丽莎;格温·s·史密斯;Leoutsakos, Jeannie Marie;辛西娅·a·门罗;哦，埃斯特s;德雷克，克里斯汀·e;保罗·b·罗森博格;威廉·s·安德森;Salloway斯蒂芬;J.卡拉·彭德格拉斯;安娜·d·伯克;大卫·沃克;唐伟，David F.;弗朗西斯科·a·庞塞;Wael F. Asaad;马尔万·萨巴格;迈克尔·s·奥肯;Baltuch,戈登;等人，“针对穹窿的深部脑刺激治疗轻度阿尔茨海默氏症:先进随机对照试验的设计”(2015)。神经病学文章。https://scholar.barrowneuro.org/neurology/30
{"title":"Deep brain stimulation targeting the fornix for mild Alzheimer dementia: design of the ADvance randomized controlled trial","authors":"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","doi":"10.2147/OAJCT.S81542","DOIUrl":"https://doi.org/10.2147/OAJCT.S81542","url":null,"abstract":"Recommended Citation Holroyd, Kathryn B.; Fosdick, Lisa; Smith, Gwenn S.; Leoutsakos, Jeannie Marie; Munro, Cynthia A.; Oh, Esther S.; Drake, Kristen E.; Rosenberg, Paul B.; Anderson, William S.; Salloway, Stephen; Pendergrass, J. Cara; Burke, Anna D.; Wolk, David A.; Tang-Wai, David F.; Ponce, Francisco A.; Asaad, Wael F.; Sabbagh, Marwan N.; Okun, Michael S.; Baltuch, Gordon; and al., et, \"Deep Brain Stimulation Targeting the Fornix for Mild Alzheimer Dementia: Design of the ADvance Randomized Controlled Trial\" (2015). Neurology Articles. 30. https://scholar.barrowneuro.org/neurology/30","PeriodicalId":19500,"journal":{"name":"Open Access Journal of Clinical Trials","volume":"7 1","pages":"63-76"},"PeriodicalIF":1.2,"publicationDate":"2015-07-10","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://sci-hub-pdf.com/10.2147/OAJCT.S81542","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"68418076","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}
S. S. Sørensen, K. M. Pedersen, U. Weinreich, L. Ehlers
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 53–62 Open Access Journal of Clinical Trials Dovepress
许可证。许可的完整条款可在http://creativecommons.org/licenses/by-nc/3.0/上获得。允许非商业用途的工作，没有任何进一步的许可，从多芬医学出版社有限公司，只要工作适当署名。超出许可范围的许可由多芬医疗新闻有限公司管理。有关如何请求许可的信息可在以下网站找到:http://www.dovepress.com/permissions.php Open Access Journal of Clinical Trials 2015:7 53-62 Open Access Journal of Clinical Trials Dovepress
{"title":"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","authors":"S. S. Sørensen, K. M. Pedersen, U. Weinreich, L. Ehlers","doi":"10.2147/OAJCT.S82533","DOIUrl":"https://doi.org/10.2147/OAJCT.S82533","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 53–62 Open Access Journal of Clinical Trials Dovepress","PeriodicalId":19500,"journal":{"name":"Open Access Journal of Clinical Trials","volume":"2015 1","pages":"53-62"},"PeriodicalIF":1.2,"publicationDate":"2015-06-18","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://sci-hub-pdf.com/10.2147/OAJCT.S82533","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"68418455","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}
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.
{"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}
Navneet Sonawane, V. Kale, S. Erande, J. Chaudhary
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 35–42 Open Access Journal of Clinical Trials Dovepress
许可证。许可的完整条款可在http://creativecommons.org/licenses/by-nc/3.0/上获得。允许非商业用途的工作，没有任何进一步的许可，从多芬医学出版社有限公司，只要工作适当署名。超出许可范围的许可由多芬医疗新闻有限公司管理。有关如何申请许可的信息可在以下网站找到:http://www.dovepress.com/permissions.php Open Access Journal of Clinical Trials 2015:7 35-42 Open Access Journal of Clinical Trials Dovepress
{"title":"Effect of GenF20 Plus on serum IGF-1 levels in healthy adults: a randomized controlled study","authors":"Navneet Sonawane, V. Kale, S. Erande, J. Chaudhary","doi":"10.2147/OAJCT.S75969","DOIUrl":"https://doi.org/10.2147/OAJCT.S75969","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 35–42 Open Access Journal of Clinical Trials Dovepress","PeriodicalId":19500,"journal":{"name":"Open Access Journal of Clinical Trials","volume":"7 1","pages":"35-42"},"PeriodicalIF":1.2,"publicationDate":"2015-03-25","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://sci-hub-pdf.com/10.2147/OAJCT.S75969","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"68415678","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}
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 23–34 Open Access Journal of Clinical Trials Dovepress
许可证。许可的完整条款可在http://creativecommons.org/licenses/by-nc/3.0/上获得。允许非商业用途的工作，没有任何进一步的许可，从多芬医学出版社有限公司，只要工作适当署名。超出许可范围的许可由多芬医疗新闻有限公司管理。有关如何申请许可的信息可在以下网站找到:http://www.dovepress.com/permissions.php Open Access Journal of Clinical Trials 2015:7 23-34 Open Access Journal of Clinical Trials Dovepress
{"title":"Conducting clinical trials in emerging markets of sub-Saharan Africa: review of guidelines and resources for foreign sponsors","authors":"Gaurav Puppalwar, M. Mourya, G. Kadhe, A. Mane","doi":"10.2147/OAJCT.S77316","DOIUrl":"https://doi.org/10.2147/OAJCT.S77316","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 23–34 Open Access Journal of Clinical Trials Dovepress","PeriodicalId":19500,"journal":{"name":"Open Access Journal of Clinical Trials","volume":"7 1","pages":"23-34"},"PeriodicalIF":1.2,"publicationDate":"2015-03-24","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://sci-hub-pdf.com/10.2147/OAJCT.S77316","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"68415900","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}
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
许可证。许可的完整条款可在http://creativecommons.org/licenses/by-nc/3.0/上获得。允许非商业用途的工作，没有任何进一步的许可，从多芬医学出版社有限公司，只要工作适当署名。超出许可范围的许可由多芬医疗新闻有限公司管理。有关如何申请许可的信息可在以下网站找到:http://www.dovepress.com/permissions.php Open Access Journal of Clinical Trials 2015:7 11-21 Open Access Journal of Clinical Trials Dovepress
{"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":"7 1","pages":"11-21"},"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}
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
: 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.
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