Open Access Journal of Clinical Trials最新文献

{"title":"A data-capture system for post-marketing surveillance of drugs that integrates with hospital electronic health records","authors":"Keiichi Yamamoto, S. Matsumoto, K. Yanagihara, S. Teramukai, M. Fukushima","doi":"10.2147/OAJCT.S19579","DOIUrl":"https://doi.org/10.2147/OAJCT.S19579","url":null,"abstract":"Keiichi Yamamoto1 shigemi Matsumoto2 Kazuhiro Yanagihara2 satoshi Teramukai1 Masanori Fukushima1,2,3 1Department of Clinical Trial Design and Management, Translational research Center, Kyoto University hospital, Kyoto, Japan; 2Outpatient Oncology Unit, Kyoto University hospital, Kyoto, Japan; 3Translational research informatics Center, Foundation for Biomedical research and innovation, Kobe, Japan","PeriodicalId":19500,"journal":{"name":"Open Access Journal of Clinical Trials","volume":"3 1","pages":"21-26"},"PeriodicalIF":1.2,"publicationDate":"2011-04-29","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://sci-hub-pdf.com/10.2147/OAJCT.S19579","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"68413035","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":"Data retention after a patient withdraws consent in clinical trials.","authors":"André P Gabriel,&nbsp;Charles P Mercado","doi":"10.2147/OAJCT.S13960","DOIUrl":"https://doi.org/10.2147/OAJCT.S13960","url":null,"abstract":"<p><p>Patient retention is critically important in the conduct of a successful clinical trial. The power in numbers in multicenter trials is dependent on the completion of follow-up for every patient randomized. If at the end of a clinical trial, a significant number of randomized patients are missing outcome data, there will not be enough pool for data analyses to conclude a study based on its primary and secondary objectives. When patients who are either lost to follow-up or who withdraw consent during the clinical trial are eliminated from the data pool, they subsequently affect the power and the validity of conclusions derived from the clinical study. This paper aims to present current guidance on data retention for patients who have withdrawn consent from clinical trials.</p>","PeriodicalId":19500,"journal":{"name":"Open Access Journal of Clinical Trials","volume":"3 ","pages":"15-19"},"PeriodicalIF":1.2,"publicationDate":"2011-04-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://sci-hub-pdf.com/10.2147/OAJCT.S13960","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"31648890","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Phase II trial of second-line erlotinib and digoxin for nonsmall cell lung cancer (NSCLC)","authors":"F. Kayali, M. Janjua, D. Laber, Donald M Miller, G. Kloecker","doi":"10.2147/OAJCT.S16347","DOIUrl":"https://doi.org/10.2147/OAJCT.S16347","url":null,"abstract":"Correspondence: goetz h Kloecker University of Louisville, 529 s. Jackson street, Louisville, KY 40202, UsA Tel +1 502 562 4358 Fax +1 502 562 6811 email ghkloe01@louisville.edu; goetzkloecker@yahoo.com Background: In vitro digoxin sensitizes cancer cells to the induction of apoptosis by c hemotherapy. Inhibition of the Na/K-ATPase enzyme by ouabain disturbs the intracellular ion composition of cancer cells, altering cellular homeostasis. This suggests that inhibition of the Na/K pump results in cellular sensitization of malignant but not benign cells to the induction of apoptosis. Epidemiologic studies have also shown beneficial effects of digitalis in breast cancer incidence. At ASCO (American Society of Clinical Oncology) 2007 our group presented a Phase II study showing encouraging results by adding digoxin to biochemotherapy for melanoma. Erlotinib is one of the standard second-line treatments for nonsmall cell lung cancer (NSCLC), with a response rate (RR) of 10%. This study’s hypothesis was that adding digoxin to erlotinib will improve the RR and time to progression (TTP) in NSCLC. Methods: Patients with progressive disease (PD) after chemotherapy were enrolled if they had an ECOG (Eastern Cooperative Oncology Group) score from 0 to 2 and good organ f unction. Daily erlotinib 150 mg and digoxin 0.25 mg were taken by mouth. The digoxin dose was adjusted to keep levels between 1 and 2 ng/mL. Computed tomography scans were done every 6 weeks. Treatment continued until PD or significant toxicity occurred. Results: Patient accrual lasted from March 2006 until August 2008 and was stopped early at the time of interim analysis. Twenty-eight patients were enrolled, and 24 who completed at least 6 weeks of therapy are presented here. All patients had unresectable NSCLC stage III/IV at diagnosis. Median age was 61 (34–78), 14 were female, 17 had prior radiation (not involving the target lesions), 23 had one prior chemotherapy, and one subject had two. Only one patient was a never-smoker. Histologies were 50% adenocarcinoma, 30% squamous, and 20% u nspecified. One patient had a partial response, nine had stable disease, and 14 had progressive disease. The median TTP was 61 days (9–366) and median survival 157 days (9–844). Side effects were similar to erlotinib single agent with no treatment-related mortality. There were no unexpected or increased adverse events related to digoxin. Conclusions: Digoxin did not increase the response rate of erlotinib in the treatment of p rogressive NSCLC. The TTP and survival seen in this study were similar to the published results with erlotinib alone. This combination does not warrant further clinical studies in NSCLC.","PeriodicalId":19500,"journal":{"name":"Open Access Journal of Clinical Trials","volume":"2017 1","pages":"9-13"},"PeriodicalIF":1.2,"publicationDate":"2011-02-06","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://sci-hub-pdf.com/10.2147/OAJCT.S16347","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"68412861","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":"Prospective evidence that HIV lipoatrophy and visceral adiposity are partially independent processes","authors":"H. Wand, D. Carey, A. Calmy, M. Law, D. Cooper, S. Emery, A. Carr","doi":"10.2147/OAJCT.S14359","DOIUrl":"https://doi.org/10.2147/OAJCT.S14359","url":null,"abstract":"Correspondence: Handan Wand national Centre in HiV Epidemiology and Clinical research, University of new South Wales, Sydney, nSW 2052, Australia Tel +61 2 9385 0900 Fax +61 2 9385 0910 Email hwand@nchecr.unsw.edu.au Purpose: To investigate the patterns of change in objectively assessed body composition parameters and to determine to what extent the observed patterns correlate with modifiable variables and potential risk factors for lipodystrophy in human immunodeficiency virus (HIV)-infected lipoatrophic adults. Method: Changes from baseline in limb fat and visceral adipose tissue (VAT), and their associations with antiretroviral therapy, body composition, and metabolic variables were investigated using linear and logistic regression models. Results: Increases in limb fat were significantly associated with higher baseline limb fat (P , 0.0001), VAT (P = 0.023), and change from baseline to week 72 in VAT (P , 0.0001). On-study use of zidovudine or stavudine was negatively associated with a limb fat increase (P = 0.017). High baseline limb fat mass and VAT had negative effects on subsequent VAT increases at week 72 (P = 0.016 and P = 0.001, respectively). Conclusions: This large, prospective study in HIV-infected adults with moderate or severe lipoatrophy at baseline showed positive associations between changes in limb fat and VAT over 72 weeks. Risk factors for these two lipodystrophic features were different. Our findings suggest that lipoatrophy and fat accumulation are at least partially independent processes.","PeriodicalId":19500,"journal":{"name":"Open Access Journal of Clinical Trials","volume":"3 1","pages":"1-7"},"PeriodicalIF":1.2,"publicationDate":"2011-01-24","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://sci-hub-pdf.com/10.2147/OAJCT.S14359","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"68412754","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":"Retrospective analysis of a South African cardiovascular trial site’s patient retention rates","authors":"L. Burgess, N. Sulzer","doi":"10.2147/OAJCT.S13896","DOIUrl":"https://doi.org/10.2147/OAJCT.S13896","url":null,"abstract":"Correspondence: Lesley J Burgess 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 lesley@treadresearch.com Introduction: Patient dropouts negatively affect study cost and validity of study results. Objectives: To investigate the attrition rate and reasons for patient discontinuations at a cardiovascular trial site in South Africa. Methods: Studies conducted over the past 10 years were randomly selected and retrospectively examined for attrition rates and reasons for patient discontinuation. Results: A total of 50 studies with a duration ranging from 3 to 45 months were examined. A total of 1386 patients were randomized. Of these, 88.9% completed all scheduled study visits, resulting in a mean 11.1% (n = 154) attrition rate. Reasons for discontinuation included death (39.6%), withdrawal of consent (33.1%), adverse events (22.7%), and relocation (4.5%). There were no patients lost to follow-up. Conclusion: The low attrition rate and absence of any patients lost to follow-up are the result of a dedicated retention plan in which each site staff member has a crucial role to play in keeping patients motivated and interested in participating in a clinical trial.","PeriodicalId":19500,"journal":{"name":"Open Access Journal of Clinical Trials","volume":"2 1","pages":"163-166"},"PeriodicalIF":1.2,"publicationDate":"2010-11-26","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://sci-hub-pdf.com/10.2147/OAJCT.S13896","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"68412608","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":"Examining the readability of patient-informed consent forms","authors":"Marli Terblanche, L. Burgess","doi":"10.2147/OAJCT.S13608","DOIUrl":"https://doi.org/10.2147/OAJCT.S13608","url":null,"abstract":"Correspondence: Marli Terblanche Room 41, Department of Cardiology, 8th Floor, Tygerberg Hospital, Parow 7500, South Africa Tel +27 21 931 7825 Fax + 27 21 933 3597 Email marli@treadresearch.com Primary objective: To investigate the readability of informed consent forms (ICF) used at TREAD Research, a private clinical trial research unit located in Tygerberg Hospital. Secondary objective: To assess if there is a difference in readability between therapeutic areas, as well as a difference in readability over two time periods. Methods: The readability of 84 ICFs given to patients at TREAD Research between the years 2000 and 2009 was quantitatively assessed by means of the Flesch–Kincaid Reading Ease, Flesch–Kincaid Grade Level, and Gunning-Fog index. Results: The mean ± standard deviation (SD) Flesch–Kincaid Reading Ease score for the 84 ICFs was 46.60 ± 5.62 (range 33.2–65.6). The mean ± SD grade level was 12.13 ± 1.8 (range 8.3–14.9) using the Flesch–Kincaid formula and 13.96 ± 1.22 (range 10.3–16.6) using the Gunning-Fog index. Readability at grade level 8 was only found in 1.2% of all the ICFs assessed. No differences were found in readability between therapeutic areas or over the two time periods. Conclusions: The main finding is that these forms are too complex to be understood by average study participants and their families.","PeriodicalId":19500,"journal":{"name":"Open Access Journal of Clinical Trials","volume":"2 1","pages":"157-162"},"PeriodicalIF":1.2,"publicationDate":"2010-10-19","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://sci-hub-pdf.com/10.2147/OAJCT.S13608","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"68413026","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":"Sodium nitroprusside-associated cyanide toxicity in adult patients – fact or fiction? A critical review of the evidence and clinical relevance","authors":"P. Abraham","doi":"10.2147/OAJCT.S7573","DOIUrl":"https://doi.org/10.2147/OAJCT.S7573","url":null,"abstract":"Correspondence: Prasad Abraham Department of Pharmacy and Drug information, Box 2061, Grady Health System, 80 Jesse Hill Jr Dr Se, Atlanta, GA 30303, USA Tel +1 404-616-3246 Fax +1 404-616-2228 email pabraham@gmh.edu Abstract: Since its US Food and Drug Administration (FDA) approval in 1974, sodium nitroprusside (SNP) has been fraught with controversy in regards to its safety. Over the years, a growing concern related to SNPs propensity to cause cyanide (CN) toxicity culminated into a series of case reports that led the FDA to develop a black-box warning with dose limitations of ,2 μg/kg/min. These recommendations stemmed also from the reality of the difficulty of obtaining CN levels in a timely manner, as well as the presumed poor correlation of metabolic markers (lactate levels and pH) as it related to the severity of CN toxicity. All these issues have driven practitioners to the use of alternative agents. In this paper, we critically review the cases and the data that led to the development of these restrictive dosing recommendations and reveal several limitations of the data and assumptions that led to these recommendations. We conclude that SNP is still a reasonable agent to use in the management of patients with hypertension today and can safely be used beyond doses of 2 μg/kg/min. Furthermore, in lieu of CN levels, monitoring of lactic acid levels is also a reasonable measure to ensure safety.","PeriodicalId":19500,"journal":{"name":"Open Access Journal of Clinical Trials","volume":"2 1","pages":"133-148"},"PeriodicalIF":1.2,"publicationDate":"2010-09-02","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://sci-hub-pdf.com/10.2147/OAJCT.S7573","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"68415656","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":"Time will tell: community acceptability of HIV vaccine research before and after the \"Step Study\" vaccine discontinuation.","authors":"Paula M Frew,&nbsp;Mark J Mulligan,&nbsp;Su-I Hou,&nbsp;Kayshin Chan,&nbsp;Carlos del Rio","doi":"10.2147/OAJCT.S11915","DOIUrl":"https://doi.org/10.2147/OAJCT.S11915","url":null,"abstract":"<p><p>OBJECTIVE: This study examines whether men-who-have-sex-with-men (MSM) and transgender (TG) persons' attitudes, beliefs, and risk perceptions toward human immunodeficiency virus (HIV) vaccine research have been altered as a result of the negative findings from a phase 2B HIV vaccine study. DESIGN: We conducted a cross-sectional survey among MSM and TG persons (N = 176) recruited from community settings in Atlanta from 2007 to 2008. The first group was recruited during an active phase 2B HIV vaccine trial in which a candidate vaccine was being evaluated (the \"Step Study\"), and the second group was recruited after product futility was widely reported in the media. METHODS: Descriptive statistics, t tests, and chi-square tests were conducted to ascertain differences between the groups, and ordinal logistic regressions examined the influences of the above-mentioned factors on a critical outcome, future HIV vaccine study participation. The ordinal regression outcomes evaluated the influences on disinclination, neutrality, and inclination to study participation. RESULTS: Behavioral outcomes such as future recruitment, event attendance, study promotion, and community mobilization did not reveal any differences in participants' intentions between the groups. However, we observed greater interest in HIV vaccine study screening (t = 1.07, P < 0.05) and enrollment (t = 1.15, P < 0.05) following negative vaccine findings. Means on perceptions, attitudes, and beliefs did not differ between the groups. Before this development, only beliefs exhibited a strong relationship on the enrollment intention (β = 2.166, P = 0.002). However, the effect disappeared following negative trial results, with the positive assessment of the study-site perceptions being the only significant contributing factor on enrollment intentions (β = 1.369, P = 0.011). CONCLUSION: Findings show greater enrollment intention among this population in the wake of negative efficacy findings from the Step Study. The resolve of this community to find an HIV vaccine is evident. Moreover, any exposure to information disseminated in the public arena did not appear to negatively influence the potential for future participation in HIV vaccine studies among this population. The results suggest that subsequent studies testing candidate vaccines could be conducted in this population.</p>","PeriodicalId":19500,"journal":{"name":"Open Access Journal of Clinical Trials","volume":"2010 2","pages":"149-156"},"PeriodicalIF":1.2,"publicationDate":"2010-09-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://sci-hub-pdf.com/10.2147/OAJCT.S11915","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"29531180","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"HeartSmart ® for routine optimization of blood flow and facilitation of early goal-directed therapy","authors":"K. Warring-Davies, Martin J. Bland","doi":"10.2147/OAJCT.S9843","DOIUrl":"https://doi.org/10.2147/OAJCT.S9843","url":null,"abstract":"The empirical physiological formulae of the new continuous cardiac dynamic monitoring HeartSmart ® technology, which involves the use of a new inverse square rule of the heart, were investigated with pulmonary artery catheter (PAC) thermodilution in the estimation of CI in diverse patients. Clinical trial data collected from 268 adult surgery or intensive care patients requiring PAC placement were obtained from 7 NHS Trust hospitals, providing 2720 paired sets of CI estimations for comparison between HeartSmart ® and PAC thermodilution. For 95% of pairs of measurements, HeartSmart ® values were between 57% and 164% of PAC measure- ments; additionally, the larger limit of agreement between HeartSmart ® and PAC thermodilution (1.26 L min -1 ·m -2 ) suggests that HeartSmart ® agrees with PAC thermodilution as closely as PAC thermodilution agrees with itself. HeartSmart ® can also estimate CI in the extreme circumstances of shock/sepsis, as indicated by PAC thermodilution CI values that were hypo- or hyperdynamic based on systemic inflammatory response syndrome criteria. In CI measurements for hypo- or hyperdynamic values that were matched between HeartSmart ® and PAC thermodilution, the difference in total volumes and average CI measurements between the two methods was less than 5%. For unmatched hypo- or hyperdynamic values, the difference between total volumes and average CI measurements was less than 33% - an acceptable percentage of difference or error even for normal values of CI. HeartSmart ® tracked PAC thermodilution CI hypodynamic values 98.2% of the time and hyperdynamic values 97.6% of the time. These findings show that CI estimations provided by the HeartSmart ® empirical physiological formulae are comparable to those obtained using PAC thermodilution. HeartSmart ® removes many of the technical barriers that prevent the routine adoption and practice of early goal-directed therapy, and represents a simple, reliable method of estimating CI and other hemodynamic variables at the bedside or in departments other than the Intensive Care Unit.","PeriodicalId":19500,"journal":{"name":"Open Access Journal of Clinical Trials","volume":"2 1","pages":"115-123"},"PeriodicalIF":1.2,"publicationDate":"2010-08-05","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://sci-hub-pdf.com/10.2147/OAJCT.S9843","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"68418818","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":"Conducting ethical clinical trials for L. donovani in the Bihar region of India","authors":"T. Crawford, B. Vesely","doi":"10.2147/OAJCT.S10967","DOIUrl":"https://doi.org/10.2147/OAJCT.S10967","url":null,"abstract":"Visceral leishmaniasis is a severe disease that disproportionally afflicts the Bihar state in India with 40% of the worldwide disease burden. Drug resistance, poor adherence, extreme poverty, malnutrition and certain living conditions have made control and treatment of the disease difficult. There is a great need for new drugs and control programs to reduce the disease burden of this debilitating and potentially fatal disease. Drug discovery research on leishmaniasis is being conducted in the USA and this raises issues concerning the ethical conduct of international clinical trials. Ethical principles dictate that the Bihari who need these drugs should be included in clinical trials. Additional safeguards for the ethical conduct of clinical trials on developing countries by developed countries have been formulated elsewhere. These include collaborative partnership, social value, scientific validity, fair selection of study population, favorable risk-benefit ratio, independent review, informed consent, and respect for recruited participants and study communities. These principles are applied to the Bihari context, and issues of ancillary care and post-trial access are also addressed. The socio-cultural context of the region is discussed in order to give researchers the tools to obtain meaningful informed consent. A description of the Bihari context and relevant ethical considerations should facilitate the design and conduct of ethical clinical trials for L. donovani.","PeriodicalId":19500,"journal":{"name":"Open Access Journal of Clinical Trials","volume":"2 1","pages":"125-131"},"PeriodicalIF":1.2,"publicationDate":"2010-08-04","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://sci-hub-pdf.com/10.2147/OAJCT.S10967","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"68412833","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}