J. Uberos, M. Nogueras-Ocaña, V. Fernández-Puentes, R. Rodríguez-Belmonte, E. Narbona-López, A. Molina-Carballo, A. Muňoz-Hoyos
Correspondence: Jose Uberos Paediatric Clinical Management Unit, San Cecilio University Clinical Hospital, Avda de Madrid s/n, Granada, Spain Phone +34 9 5802 3411 Fax +34 958246661 Email juberos@ugr.es Objectives: The present study forms part of the ISRCTN16968287 clinical assay. The objective of this study was to determine the effectiveness of cranberry syrup in the prophylaxis of recurrent urinary tract infection (UTI). Design: Phase III randomized clinical trial. Setting: The study was conducted at the San Cecilio Clinical Hospital (Granada, Spain). Participants: A total of 192 patients were recruited. The subjects were aged between 1 month and 13 years. Criteria for inclusion were a background of recurrent UTI (more than two episodes of infection in the last 6 months), associated or otherwise with vesicoureteral reflux of any degree, or renal pelvic dilatation associated with UTI. Criteria for exclusion from recruitment to the study included the co-existence of UTI with other infectious diseases or with metabolic diseases, chronic renal insufficiency, and the presence of allergy or intolerance to any of the components of cranberry syrup or trimethoprim. Primary outcome measures: The primary objective was to determine the risk of UTI associated with each intervention. Results: Of the 198 patients initially eligible, 192 were finally included in the study to receive either cranberry syrup or trimethoprim. UTI was observed in 47 patients, 17 of whom were males and 30 females. We recruited 95 patients diagnosed with recurrent UTI on entry; during follow-up, 26 patients had a UTI (27.4%, 95% CI: 18.4%–36.3%). Six patients (6.3%) were male and 20 (21.1%) were female. Eighteen patients (18.9% of the total, 95% CI: 11%–26.3%) receiving trimethoprim had a UTI and eight patients (8.4% of the total, 95% CI: 2.8%–13.9%) were given cranberry. Sixty-six percent of the episodes of UTI recurrence were caused by Escherichia coli, with no significant differences being found between the two treatment branches. No differences were observed between the two treatment branches in the rate of resistance to antibiotics. Conclusion: Our study confirms that cranberry syrup is a safe treatment for the pediatric population. Cranberry prophylaxis has noninferiority with respect to trimethoprim in recurrent UTI. (European Clinical Trials Registry EuDract 2007-004397-62) (ISRCTN16968287).
{"title":"Cranberry syrup vs trimethoprim in the prophylaxis of recurrent urinary tract infections among children: a controlled trial","authors":"J. Uberos, M. Nogueras-Ocaña, V. Fernández-Puentes, R. Rodríguez-Belmonte, E. Narbona-López, A. Molina-Carballo, A. Muňoz-Hoyos","doi":"10.2147/OAJCT.S31734","DOIUrl":"https://doi.org/10.2147/OAJCT.S31734","url":null,"abstract":"Correspondence: Jose Uberos Paediatric Clinical Management Unit, San Cecilio University Clinical Hospital, Avda de Madrid s/n, Granada, Spain Phone +34 9 5802 3411 Fax +34 958246661 Email juberos@ugr.es Objectives: The present study forms part of the ISRCTN16968287 clinical assay. The objective of this study was to determine the effectiveness of cranberry syrup in the prophylaxis of recurrent urinary tract infection (UTI). Design: Phase III randomized clinical trial. Setting: The study was conducted at the San Cecilio Clinical Hospital (Granada, Spain). Participants: A total of 192 patients were recruited. The subjects were aged between 1 month and 13 years. Criteria for inclusion were a background of recurrent UTI (more than two episodes of infection in the last 6 months), associated or otherwise with vesicoureteral reflux of any degree, or renal pelvic dilatation associated with UTI. Criteria for exclusion from recruitment to the study included the co-existence of UTI with other infectious diseases or with metabolic diseases, chronic renal insufficiency, and the presence of allergy or intolerance to any of the components of cranberry syrup or trimethoprim. Primary outcome measures: The primary objective was to determine the risk of UTI associated with each intervention. Results: Of the 198 patients initially eligible, 192 were finally included in the study to receive either cranberry syrup or trimethoprim. UTI was observed in 47 patients, 17 of whom were males and 30 females. We recruited 95 patients diagnosed with recurrent UTI on entry; during follow-up, 26 patients had a UTI (27.4%, 95% CI: 18.4%–36.3%). Six patients (6.3%) were male and 20 (21.1%) were female. Eighteen patients (18.9% of the total, 95% CI: 11%–26.3%) receiving trimethoprim had a UTI and eight patients (8.4% of the total, 95% CI: 2.8%–13.9%) were given cranberry. Sixty-six percent of the episodes of UTI recurrence were caused by Escherichia coli, with no significant differences being found between the two treatment branches. No differences were observed between the two treatment branches in the rate of resistance to antibiotics. Conclusion: Our study confirms that cranberry syrup is a safe treatment for the pediatric population. Cranberry prophylaxis has noninferiority with respect to trimethoprim in recurrent UTI. (European Clinical Trials Registry EuDract 2007-004397-62) (ISRCTN16968287).","PeriodicalId":19500,"journal":{"name":"Open Access Journal of Clinical Trials","volume":"4 1","pages":"31-38"},"PeriodicalIF":1.2,"publicationDate":"2012-05-23","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://sci-hub-pdf.com/10.2147/OAJCT.S31734","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"68413499","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}
A. Shakeel, Hoong Keong Hui, Chetan S Patil, M. V. Chaudhari, Y. Kadam, Shrikant V Pensalwar, S. Erande, Rajesh M Kewalramani
Aliya Shakeel1 Hoong Keong Hui2 Chetan S Patil3 Manojkumar V Chaudhari4 Yogesh D Kadam5 Shrikant V Pensalwar6 Suhas G Erande7 Rajesh M Kewalramani8 1Vedic Lifesciences Pvt Ltd, Mumbai, Maharashtra, India; 2Nutriworks Limited, Kowloon, Hong Kong; 3Muktai Hospital, Nasik, 4Bhagirathi Medical Foundation, 5Poona Diabetes Center, 6Balaji Clinic, Mumbai, 7Akshay Hospital, Pune, 8Shanti Niketan, Kandar Pada, Dahisar, Mumbai, Maharashtra, India
Aliya Shakeel1 Hoong Keong Hui2 Chetan S pati3 Manojkumar V Chaudhari4 Yogesh D Kadam5 Shrikant V Pensalwar6 Suhas G erand7 Rajesh M Kewalramani8 vedic生命科学私人有限公司，孟买，马哈拉施特拉邦，印度;2营养工场有限公司，香港九龙;3纳斯克穆克泰医院，4巴吉拉蒂医疗基金会，5普那糖尿病中心，6孟买巴拉吉诊所，7浦那阿克谢医院，8孟买，坎达尔帕达，达希萨尔，印度马哈拉施特拉邦
{"title":"Is Patch It ® better than placebo in alleviating swelling and ache in the lower legs and feet? A randomized, placebo-controlled, double blind, crossover, sequential trial","authors":"A. Shakeel, Hoong Keong Hui, Chetan S Patil, M. V. Chaudhari, Y. Kadam, Shrikant V Pensalwar, S. Erande, Rajesh M Kewalramani","doi":"10.2147/OAJCT.S29426","DOIUrl":"https://doi.org/10.2147/OAJCT.S29426","url":null,"abstract":"Aliya Shakeel1 Hoong Keong Hui2 Chetan S Patil3 Manojkumar V Chaudhari4 Yogesh D Kadam5 Shrikant V Pensalwar6 Suhas G Erande7 Rajesh M Kewalramani8 1Vedic Lifesciences Pvt Ltd, Mumbai, Maharashtra, India; 2Nutriworks Limited, Kowloon, Hong Kong; 3Muktai Hospital, Nasik, 4Bhagirathi Medical Foundation, 5Poona Diabetes Center, 6Balaji Clinic, Mumbai, 7Akshay Hospital, Pune, 8Shanti Niketan, Kandar Pada, Dahisar, Mumbai, Maharashtra, India","PeriodicalId":19500,"journal":{"name":"Open Access Journal of Clinical Trials","volume":"4 1","pages":"21-29"},"PeriodicalIF":1.2,"publicationDate":"2012-04-24","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://sci-hub-pdf.com/10.2147/OAJCT.S29426","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"68413281","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}
Correspondence: Hans Joergen Soegaard Forskningsenhed Vest, Center for Psykiatrisk Forskning, Gl Landevej 43, 7400 Herning, Denmark Tel +45 7847 4660 Fax +45 7847 4637 Email hans-joergen.soegaard@ps.rm.dk Background: Intervention studies in sickness absence research demonstrate a low effect and ambiguous results in reducing sickness absence and improving work status. The aim of this study was to determine if the effect of interventions is related to type of intervention, target population, inclusion criteria used, and impact of the scientific quality of the studies. Methods: Based on a structured review of 57 studies, short-term, medium-term, and longterm effects were analyzed with regard to the type of intervention, target population, inclusion criteria, and scientific quality of the studies. Results: The overall result was that the effect rate was low, ie, about 20% for short-term effect (up to 6 months) and medium-term effect (6–12 months), and 40% for long-term effect ($12 months). Interventions using stress reduction were most effective with regard to shortterm and medium-term effects, whereas collaborative care was most effective for long-term effects. The effects were related to the inclusion criteria and, to a minor degree, to the scientific quality of the studies. Conclusion: In the field of sickness absence research, more attention should be paid to the interrelationship between the types of interventions, target populations, and inclusion criteria for the studies. Larger studies of high methodological quality are needed. Steps should be taken to standardize outcome measures.
{"title":"Variation in effect of intervention studies in research on sickness absence","authors":"H. Soegaard","doi":"10.2147/OAJCT.S25651","DOIUrl":"https://doi.org/10.2147/OAJCT.S25651","url":null,"abstract":"Correspondence: Hans Joergen Soegaard Forskningsenhed Vest, Center for Psykiatrisk Forskning, Gl Landevej 43, 7400 Herning, Denmark Tel +45 7847 4660 Fax +45 7847 4637 Email hans-joergen.soegaard@ps.rm.dk Background: Intervention studies in sickness absence research demonstrate a low effect and ambiguous results in reducing sickness absence and improving work status. The aim of this study was to determine if the effect of interventions is related to type of intervention, target population, inclusion criteria used, and impact of the scientific quality of the studies. Methods: Based on a structured review of 57 studies, short-term, medium-term, and longterm effects were analyzed with regard to the type of intervention, target population, inclusion criteria, and scientific quality of the studies. Results: The overall result was that the effect rate was low, ie, about 20% for short-term effect (up to 6 months) and medium-term effect (6–12 months), and 40% for long-term effect ($12 months). Interventions using stress reduction were most effective with regard to shortterm and medium-term effects, whereas collaborative care was most effective for long-term effects. The effects were related to the inclusion criteria and, to a minor degree, to the scientific quality of the studies. Conclusion: In the field of sickness absence research, more attention should be paid to the interrelationship between the types of interventions, target populations, and inclusion criteria for the studies. Larger studies of high methodological quality are needed. Steps should be taken to standardize outcome measures.","PeriodicalId":19500,"journal":{"name":"Open Access Journal of Clinical Trials","volume":"4 1","pages":"1-20"},"PeriodicalIF":1.2,"publicationDate":"2012-04-24","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://sci-hub-pdf.com/10.2147/OAJCT.S25651","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"68413153","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}
A. Offianan, S. Assi, A. Coulibaly, L. T. N’Guessan, A. A. Ako, Florence Kadjo, Moïse K San, L. Penali
Correspondence: Andre T Offianan Malariology Department, Institut Pasteur de Cote d’Ivoire, PO Box 490, Abidjan 01, Cote d’Ivoire Tel +225 22 44 84 25 Fax +225 22 48 53 05 Email andre_offianan@yahoo.fr Background: The emergence of artemisinin resistance has raised concerns that the most potent antimalarial drug may be under threat. Artesunate + amodiaquine (ASAQ) and artemetherlumefantrine (AL) are respectively the firstand second-line treatments for uncomplicated falciparum malaria in Cote d’Ivoire. A comparison of the efficacy and safety of these two drug combinations was necessary to make evidence-based drug treatment policies. Methods: In an open-label, non inferiority, randomized, controlled clinical trial, children aged 6–59 months were randomized to receive ASAQ or AL. Both drug regimens were given for 3 days, and follow-up was for 28 days. The primary endpoint was the 28-day cure rates and was defined as proportion of patients with polymerase chain reaction (PCR)-corrected cure rate after 28 days of follow-up. Findings: A total of 251 patients who were attending the Ayame and Dabakala hospitals and presenting with symptomatic acute uncomplicated falciparum malaria were randomized to receive ASAQ (128) and AL (123). The intention-to-treat analysis showed effectiveness rates of 94.5% and 93.5% for ASAQ and AL, respectively on day 28. After adjustment for PCR results, these rates were 96.1% and 96.8%, respectively. On day 28, the per-protocol analysis showed effectiveness rates of 98.4% and 96.6% for ASAQ and AL, respectively. After adjustment by PCR for reinfection, these rates were 100% for each drug, and both regimens were well tolerated. Conclusion: ASAQ and AL remain efficacious treatments of uncomplicated falciparum malaria in Ivorian children 5 years after adoption. The efficacy of ASAQ and AL in Cote d’Ivoire requires, therefore, continuous monitoring and evaluation.
{"title":"Assessment of the efficacy of first-line antimalarial drugs after 5 years of deployment by the National Malaria Control Programme in Côte d'Ivoire","authors":"A. Offianan, S. Assi, A. Coulibaly, L. T. N’Guessan, A. A. Ako, Florence Kadjo, Moïse K San, L. Penali","doi":"10.2147/OAJCT.S24687","DOIUrl":"https://doi.org/10.2147/OAJCT.S24687","url":null,"abstract":"Correspondence: Andre T Offianan Malariology Department, Institut Pasteur de Cote d’Ivoire, PO Box 490, Abidjan 01, Cote d’Ivoire Tel +225 22 44 84 25 Fax +225 22 48 53 05 Email andre_offianan@yahoo.fr Background: The emergence of artemisinin resistance has raised concerns that the most potent antimalarial drug may be under threat. Artesunate + amodiaquine (ASAQ) and artemetherlumefantrine (AL) are respectively the firstand second-line treatments for uncomplicated falciparum malaria in Cote d’Ivoire. A comparison of the efficacy and safety of these two drug combinations was necessary to make evidence-based drug treatment policies. Methods: In an open-label, non inferiority, randomized, controlled clinical trial, children aged 6–59 months were randomized to receive ASAQ or AL. Both drug regimens were given for 3 days, and follow-up was for 28 days. The primary endpoint was the 28-day cure rates and was defined as proportion of patients with polymerase chain reaction (PCR)-corrected cure rate after 28 days of follow-up. Findings: A total of 251 patients who were attending the Ayame and Dabakala hospitals and presenting with symptomatic acute uncomplicated falciparum malaria were randomized to receive ASAQ (128) and AL (123). The intention-to-treat analysis showed effectiveness rates of 94.5% and 93.5% for ASAQ and AL, respectively on day 28. After adjustment for PCR results, these rates were 96.1% and 96.8%, respectively. On day 28, the per-protocol analysis showed effectiveness rates of 98.4% and 96.6% for ASAQ and AL, respectively. After adjustment by PCR for reinfection, these rates were 100% for each drug, and both regimens were well tolerated. Conclusion: ASAQ and AL remain efficacious treatments of uncomplicated falciparum malaria in Ivorian children 5 years after adoption. The efficacy of ASAQ and AL in Cote d’Ivoire requires, therefore, continuous monitoring and evaluation.","PeriodicalId":19500,"journal":{"name":"Open Access Journal of Clinical Trials","volume":"3 1","pages":"67-76"},"PeriodicalIF":1.2,"publicationDate":"2011-11-11","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://sci-hub-pdf.com/10.2147/OAJCT.S24687","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"68413091","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}
Naeem A Ali, David Gutteridge, Sajid Shahul, William Checkley, Jonathan Sevransky, Greg S Martin
Introduction: Many individual Intensive Care Unit (ICU) characteristics have been associated with patient outcomes, including staffing, expertise, continuity and team structure. Separately, many aspects of clinical care in ICUs have been operationalized through the development of complex treatment protocols. The United State Critical Illness and Injury Trials Group-Critical Illness Outcomes Study (USCIITG-CIOS) was designed to determine whether the extent of protocol availability and use in ICUs is associated with hospital survival in a large cohort of United States ICUs. Here, we describe the study protocol and analysis plan approved by the USCIITG-CIOS Steering Committee.
Methods: USCIITG-CIOS is a prospective, observational, ecological multi-centered "cohort" study of mixed ICUs in the U.S. The data collected include organizational information for the ICU (e.g., protocol availability and utilization, multi-disciplinary staffing assessment) and patient level information (e.g. demographics, acute and chronic medical conditions). The primary outcome is all-cause hospital mortality, with the objective being to determine whether there is an association between protocol number and hospital mortality for ICU patients. USCIITG-CIOS is powered to detect a 3% difference in crude hospital mortality between high and low protocol use ICUs, dichotomized according to protocol number at the median. The analysis will utilize regression modeling to adjust for outcome clustering by ICU, with secondary linear analysis of protocol number and mortality and a variety of a priori planned ancillary studies. There are presently 60 ICUs participating in USCIITG-CIOS to enroll approximately 6,000 study subjects.
Conclusions: USCIITG-CIOS is a large multicentric study examining the effect of ICU protocol use on patient outcomes. The primary results of this study will inform our understanding of the relationship between protocol availability, use, and patient outcomes in the ICU. Moreover, given the shortage of intensivists worldwide, the results of USCIITG-CIOS can be used to promote more effective ICU and care team design and will impact the delivery of intensive care services beyond individual practitioners.
{"title":"Critical Illness Outcome Study: An Observational Study on Protocols and Mortality in Intensive Care Units.","authors":"Naeem A Ali, David Gutteridge, Sajid Shahul, William Checkley, Jonathan Sevransky, Greg S Martin","doi":"10.2147/OAJCT.S24223","DOIUrl":"https://doi.org/10.2147/OAJCT.S24223","url":null,"abstract":"<p><strong>Introduction: </strong>Many individual Intensive Care Unit (ICU) characteristics have been associated with patient outcomes, including staffing, expertise, continuity and team structure. Separately, many aspects of clinical care in ICUs have been operationalized through the development of complex treatment protocols. The United State Critical Illness and Injury Trials Group-Critical Illness Outcomes Study (USCIITG-CIOS) was designed to determine whether the extent of protocol availability and use in ICUs is associated with hospital survival in a large cohort of United States ICUs. Here, we describe the study protocol and analysis plan approved by the USCIITG-CIOS Steering Committee.</p><p><strong>Methods: </strong>USCIITG-CIOS is a prospective, observational, ecological multi-centered \"cohort\" study of mixed ICUs in the U.S. The data collected include organizational information for the ICU (e.g., protocol availability and utilization, multi-disciplinary staffing assessment) and patient level information (e.g. demographics, acute and chronic medical conditions). The primary outcome is all-cause hospital mortality, with the objective being to determine whether there is an association between protocol number and hospital mortality for ICU patients. USCIITG-CIOS is powered to detect a 3% difference in crude hospital mortality between high and low protocol use ICUs, dichotomized according to protocol number at the median. The analysis will utilize regression modeling to adjust for outcome clustering by ICU, with secondary linear analysis of protocol number and mortality and a variety of <i>a priori</i> planned ancillary studies. There are presently 60 ICUs participating in USCIITG-CIOS to enroll approximately 6,000 study subjects.</p><p><strong>Conclusions: </strong>USCIITG-CIOS is a large multicentric study examining the effect of ICU protocol use on patient outcomes. The primary results of this study will inform our understanding of the relationship between protocol availability, use, and patient outcomes in the ICU. Moreover, given the shortage of intensivists worldwide, the results of USCIITG-CIOS can be used to promote more effective ICU and care team design and will impact the delivery of intensive care services beyond individual practitioners.</p><p><strong>Trial registration: </strong>ClinicalTrials.gov Identifier NCT01109719.</p>","PeriodicalId":19500,"journal":{"name":"Open Access Journal of Clinical Trials","volume":"2011 3","pages":"55-65"},"PeriodicalIF":1.2,"publicationDate":"2011-09-23","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://sci-hub-pdf.com/10.2147/OAJCT.S24223","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"32841614","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}
Correspondence: LJ Burgess TREAD Research/Cardiology Unit, Department of Internal Medicine, Tygerberg Hospital and Stellenbosch University, Parow 7505, South Africa Tel +27 21 931 7825 Fax +27 21 933 3597 Email lesley@treadresearch.com Objectives: To retrospectively analyze feasibility questionnaires to evaluate the number of trials that resulted in patient enrolment and the mean time frame involved. Methods: This study was conducted by TREAD Research, a site-managed organization based in the Western Cape, South Africa, between January 2004 and December 2009. All feasibility questionnaires received by the site over this time period were analyzed. Descriptive statistics were used to analyze the data. Results: A total of 252 feasibility questionnaires were received; 207 were accepted and 45 rejected. An average of 26.8% of trials started out of those feasibilities that were accepted by the site. The average time frame from feasibility acceptance to patient enrolment was 12.9 months (range 2.7–33.5 months). Conclusion: Improving the trial feasibility process would markedly improve a trial site’s ability to plan effectively and efficiently allocate appropriate resources.
{"title":"Examining the clinical trial feasibility process and its implications for a trial site","authors":"L. Burgess, L. Burgess, N. Sulzer","doi":"10.2147/OAJCT.S23631","DOIUrl":"https://doi.org/10.2147/OAJCT.S23631","url":null,"abstract":"Correspondence: LJ Burgess TREAD Research/Cardiology Unit, Department of Internal Medicine, Tygerberg Hospital and Stellenbosch University, Parow 7505, South Africa Tel +27 21 931 7825 Fax +27 21 933 3597 Email lesley@treadresearch.com Objectives: To retrospectively analyze feasibility questionnaires to evaluate the number of trials that resulted in patient enrolment and the mean time frame involved. Methods: This study was conducted by TREAD Research, a site-managed organization based in the Western Cape, South Africa, between January 2004 and December 2009. All feasibility questionnaires received by the site over this time period were analyzed. Descriptive statistics were used to analyze the data. Results: A total of 252 feasibility questionnaires were received; 207 were accepted and 45 rejected. An average of 26.8% of trials started out of those feasibilities that were accepted by the site. The average time frame from feasibility acceptance to patient enrolment was 12.9 months (range 2.7–33.5 months). Conclusion: Improving the trial feasibility process would markedly improve a trial site’s ability to plan effectively and efficiently allocate appropriate resources.","PeriodicalId":19500,"journal":{"name":"Open Access Journal of Clinical Trials","volume":"3 1","pages":"51-54"},"PeriodicalIF":1.2,"publicationDate":"2011-09-09","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://sci-hub-pdf.com/10.2147/OAJCT.S23631","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"68413420","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}
Correspondence: Marli Terblanche TReAD Research/Cardiology Unit, Department of internal Medicine, Tygerberg Hospital and Stellenbosch University, Parow, South Africa Tel +27 21 931 7825 Fax +27 21 933 3597 email marli@treadresearch.com Abstract: Numerous factors contribute to the declining pharmaceutical industry on the one hand and the rapidly growing generic industry together with the growing importance of medical devices and biologicals on the other. It is clear that the pharmaceutical industry is going to undergo a change in the next decade in order to meet the current challenges facing it and ultimately sustain its profitability and growth. This paper aims to identify a number of fairly obvious trends that are likely to have a significant impact on the product development pipeline in the next decade. It is more than clear that the current production pipeline for pharmaceutical, biotechnology and medical device industries is no longer sustainable and that urgent interventions are required in order to maintain its current level of profitability.
{"title":"The future of the pharmaceutical, biological and medical device industry","authors":"L. Burgess, Marli Terblanche","doi":"10.2147/OAJCT.S22199","DOIUrl":"https://doi.org/10.2147/OAJCT.S22199","url":null,"abstract":"Correspondence: Marli Terblanche TReAD Research/Cardiology Unit, Department of internal Medicine, Tygerberg Hospital and Stellenbosch University, Parow, South Africa Tel +27 21 931 7825 Fax +27 21 933 3597 email marli@treadresearch.com Abstract: Numerous factors contribute to the declining pharmaceutical industry on the one hand and the rapidly growing generic industry together with the growing importance of medical devices and biologicals on the other. It is clear that the pharmaceutical industry is going to undergo a change in the next decade in order to meet the current challenges facing it and ultimately sustain its profitability and growth. This paper aims to identify a number of fairly obvious trends that are likely to have a significant impact on the product development pipeline in the next decade. It is more than clear that the current production pipeline for pharmaceutical, biotechnology and medical device industries is no longer sustainable and that urgent interventions are required in order to maintain its current level of profitability.","PeriodicalId":19500,"journal":{"name":"Open Access Journal of Clinical Trials","volume":"3 1","pages":"45-50"},"PeriodicalIF":1.2,"publicationDate":"2011-09-07","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://sci-hub-pdf.com/10.2147/OAJCT.S22199","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"68413369","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}
The Open Access Journal of Clinical Trials began in 2009 with the goal of being an authoritative, open access source for international, peer-reviewed publications in the field of human research and clinical trials. Since then, the Open Access Journal of Clinical Trials has published approximately 30 high-quality articles on original research, innovative reviews, and critical commentaries. These articles have spanned many aspects of clinical trials wonderfully, including trial design and management; legal, ethical and regulatory issues of clinical trials; subject participation and retention in clinical trials; and data collection and data management. The breadth of subjects covered is remarkable, with articles discussing study subject enrollment, engagement, and retention;1–4 the effects of participant heterogeneity on intermediate phase clinical trials;5 important methodological concerns with complementary and alternative medications;6 modern issues with clinical-trial data management;7 and state-of-the-art reviews of clinical importance such as pharmacological drug toxicity8 and biomarkers in cardiovascular diseases.9 To complement these contemporary commentaries and reviews, the Open Access Journal of Clinical Trials has published original research in a number of different fields in medicine, biostatistics, and epidemiology. Perhaps even more remarkable than the breadth of subjects is the international representation of authors, who hail from Europe, Africa, Australasia, and North America. As a testament to the diversity and value presented by the Open Access Journal of Clinical Trials, I encourage you to browse the recent editions and pick one of the articles that piques your interest. Authors of manuscripts submitted to the Open Access Journal of Clinical Trials have enjoyed rapid review and publication, with the first set of reviewer comments currently being returned in an average of only 10 days. This is remarkable in an era of burgeoning clinical research and growth in the biomedical sciences, and authors have found that our peer reviewers’ comments are both focused and critically useful for improving their manuscript. The open access format and online publication process have enabled the reviewers and editorial staff to work more efficiently despite the international nature of the submissions and the reviewers. In addition, the open access journal format and electronic nature of the journal makes published manuscripts freely available to anyone in the world. Another benefit of the manuscript system used by the Open Access Journal of Clinical Trials is the opportunity for authors to become “Favored Authors” to permit fast-tracking and personal coordination of submitted manuscripts, as well as a discount on publication processing fees (http://www.dovepress.com/fav_author.php). With such an outstanding start to a new journal, the future of Open Access Journal of Clinical Trials is bright indeed! The field of clinical and translational
{"title":"Clinical trials: innovation, progress and controversy.","authors":"Greg S Martin","doi":"10.2147/OAJCT.S22967","DOIUrl":"https://doi.org/10.2147/OAJCT.S22967","url":null,"abstract":"The Open Access Journal of Clinical Trials began in 2009 with the goal of being an authoritative, open access source for international, peer-reviewed publications in the field of human research and clinical trials. Since then, the Open Access Journal of Clinical Trials has published approximately 30 high-quality articles on original research, innovative reviews, and critical commentaries. These articles have spanned many aspects of clinical trials wonderfully, including trial design and management; legal, ethical and regulatory issues of clinical trials; subject participation and retention in clinical trials; and data collection and data management. The breadth of subjects covered is remarkable, with articles discussing study subject enrollment, engagement, and retention;1–4 the effects of participant heterogeneity on intermediate phase clinical trials;5 important methodological concerns with complementary and alternative medications;6 modern issues with clinical-trial data management;7 and state-of-the-art reviews of clinical importance such as pharmacological drug toxicity8 and biomarkers in cardiovascular diseases.9 To complement these contemporary commentaries and reviews, the Open Access Journal of Clinical Trials has published original research in a number of different fields in medicine, biostatistics, and epidemiology. Perhaps even more remarkable than the breadth of subjects is the international representation of authors, who hail from Europe, Africa, Australasia, and North America. As a testament to the diversity and value presented by the Open Access Journal of Clinical Trials, I encourage you to browse the recent editions and pick one of the articles that piques your interest. \u0000 \u0000Authors of manuscripts submitted to the Open Access Journal of Clinical Trials have enjoyed rapid review and publication, with the first set of reviewer comments currently being returned in an average of only 10 days. This is remarkable in an era of burgeoning clinical research and growth in the biomedical sciences, and authors have found that our peer reviewers’ comments are both focused and critically useful for improving their manuscript. The open access format and online publication process have enabled the reviewers and editorial staff to work more efficiently despite the international nature of the submissions and the reviewers. In addition, the open access journal format and electronic nature of the journal makes published manuscripts freely available to anyone in the world. Another benefit of the manuscript system used by the Open Access Journal of Clinical Trials is the opportunity for authors to become “Favored Authors” to permit fast-tracking and personal coordination of submitted manuscripts, as well as a discount on publication processing fees (http://www.dovepress.com/fav_author.php). \u0000 \u0000With such an outstanding start to a new journal, the future of Open Access Journal of Clinical Trials is bright indeed! The field of clinical and translational ","PeriodicalId":19500,"journal":{"name":"Open Access Journal of Clinical Trials","volume":"2011 3","pages":"43-44"},"PeriodicalIF":1.2,"publicationDate":"2011-08-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://sci-hub-pdf.com/10.2147/OAJCT.S22967","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"29999314","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}
Bing Liu, F. Yi, H. Cai, Wen-yi Guo, Weijie Li, M. Shen, J. Xia, Li-wen Liu, Hai-Chang Wang
Bing Liu1* Fu Yi1* hongwei Cai2 Wenyi guo1 Weijie Li1 Min shen1 Jielai Xia3 Liwen Liu4 haichang Wang1 on behalf of The ADOPT study steering Committee and investigators 1Department of Cardiology, Xijing hospital, FMMU, Xi’an, China; 2Department of information, school of stomatology, FMMU, Xi’an, China; 3Department of statistics, FMMU, Xi’an, China; 4Department of Ultrasound, Xijing hospital, FMMU, Xi’an, China
{"title":"The ADOPT trial (Assessment of Efficacies of Cardiac Resynchronization Therapies (CRT-P/D) for Heart Failure Patients in China): rationale, design, and end-points","authors":"Bing Liu, F. Yi, H. Cai, Wen-yi Guo, Weijie Li, M. Shen, J. Xia, Li-wen Liu, Hai-Chang Wang","doi":"10.2147/OAJCT.S19583","DOIUrl":"https://doi.org/10.2147/OAJCT.S19583","url":null,"abstract":"Bing Liu1* Fu Yi1* hongwei Cai2 Wenyi guo1 Weijie Li1 Min shen1 Jielai Xia3 Liwen Liu4 haichang Wang1 on behalf of The ADOPT study steering Committee and investigators 1Department of Cardiology, Xijing hospital, FMMU, Xi’an, China; 2Department of information, school of stomatology, FMMU, Xi’an, China; 3Department of statistics, FMMU, Xi’an, China; 4Department of Ultrasound, Xijing hospital, FMMU, Xi’an, China","PeriodicalId":19500,"journal":{"name":"Open Access Journal of Clinical Trials","volume":"19 1","pages":"35-41"},"PeriodicalIF":1.2,"publicationDate":"2011-06-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://sci-hub-pdf.com/10.2147/OAJCT.S19583","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"68413223","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}
Hitesh Shah, A. Shakeel, N. Karne, Chetan S Patil, Rajesh M Kewalramani, V. Kasodekar, Malhar Dave
Objective: To assess the safety and efficacy of phenyramidol hydrochloride tablets in acute conditions of lumbago, integumental pain and musculo-skeletal pain. Methods: This open label, noncomparative, phase IV study recruited adult patients with acute lumbago, integumental pain and musculoskeletal pain who gave written informed consent. Those with elevated liver enzymes, or on analgesics, muscle relaxants, tranquilizers, anti-coagulants, or anti-epileptics were excluded as were pregnant/lactating women. 1 to 2 tablets of 400 mg phenyramidol were given orally 2 to 3 times daily for 3 to 7 days. Safety measures included complete blood count (CBC); liver and renal function tests; electrocardiogram (ECG); global assessments and adverse events. Efficacy measures included change in numerical pain rating scale (NPRS) score and global assessments. Results: 100 patients completed the study. There were no serious adverse events (SAEs) or deaths. The mean (SEM) reduction in the total white blood cell count [0.27 (0.13) thou/µL, P , 0.05] and the mean (SEM) increase in the serum glutamic pyruvic transaminase (SGPT) level [8.78 (3.40) U/L, P , 0.05] were not clinically significant at the end of the treatment period. Investigators’ assessment of safety was: 80% – excellent, 13% – good, 7% – fair. Tolerability grading by patients was: 53% – excellent, 34% – good, 12% – fair; 1% – poor. Out of the total 12 adverse events (AEs) recorded in 11% patients, 7 were clinical, while 5 were laboratory-related pertaining to increased liver enzymes (5%). The average NPRS score showed an improvement of 68% (P , 0.0001). Investigators assessed 89% patients to have clinically meaningful improvement, patients’ assessment of efficacy was: excellent – 43%; good – 38%; fair – 15%; poor – 4%. Conclusion: Phenyramidol is effective and well-tolerated in acute lumbago, musculoskeletal pain and integumental pain when given for up to 7 days. However it should be used with caution in patients with liver disease and with drugs known to cause liver damage.
{"title":"Phenyramidol in acute conditions of lumbago, integumental pain and musculo-skeletal pain: an open label, noncomparative, multi-center study","authors":"Hitesh Shah, A. Shakeel, N. Karne, Chetan S Patil, Rajesh M Kewalramani, V. Kasodekar, Malhar Dave","doi":"10.2147/OAJCT.S18505","DOIUrl":"https://doi.org/10.2147/OAJCT.S18505","url":null,"abstract":"Objective: To assess the safety and efficacy of phenyramidol hydrochloride tablets in acute conditions of lumbago, integumental pain and musculo-skeletal pain. Methods: This open label, noncomparative, phase IV study recruited adult patients with acute lumbago, integumental pain and musculoskeletal pain who gave written informed consent. Those with elevated liver enzymes, or on analgesics, muscle relaxants, tranquilizers, anti-coagulants, or anti-epileptics were excluded as were pregnant/lactating women. 1 to 2 tablets of 400 mg phenyramidol were given orally 2 to 3 times daily for 3 to 7 days. Safety measures included complete blood count (CBC); liver and renal function tests; electrocardiogram (ECG); global assessments and adverse events. Efficacy measures included change in numerical pain rating scale (NPRS) score and global assessments. Results: 100 patients completed the study. There were no serious adverse events (SAEs) or deaths. The mean (SEM) reduction in the total white blood cell count [0.27 (0.13) thou/µL, P , 0.05] and the mean (SEM) increase in the serum glutamic pyruvic transaminase (SGPT) level [8.78 (3.40) U/L, P , 0.05] were not clinically significant at the end of the treatment period. Investigators’ assessment of safety was: 80% – excellent, 13% – good, 7% – fair. Tolerability grading by patients was: 53% – excellent, 34% – good, 12% – fair; 1% – poor. Out of the total 12 adverse events (AEs) recorded in 11% patients, 7 were clinical, while 5 were laboratory-related pertaining to increased liver enzymes (5%). The average NPRS score showed an improvement of 68% (P , 0.0001). Investigators assessed 89% patients to have clinically meaningful improvement, patients’ assessment of efficacy was: excellent – 43%; good – 38%; fair – 15%; poor – 4%. Conclusion: Phenyramidol is effective and well-tolerated in acute lumbago, musculoskeletal pain and integumental pain when given for up to 7 days. However it should be used with caution in patients with liver disease and with drugs known to cause liver damage.","PeriodicalId":19500,"journal":{"name":"Open Access Journal of Clinical Trials","volume":"59 1","pages":"27-33"},"PeriodicalIF":1.2,"publicationDate":"2011-05-10","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://sci-hub-pdf.com/10.2147/OAJCT.S18505","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"68412936","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}
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