analysis of clinical trials with time to event endpoints

... terms of having the financial and the business analysis of the company 46 Business and Financial Analysis of BP with comparison to Shell PLC 4.3 2011 Financial analysis of the British petroleum with ... Financial Analysis of BP with comparison to Shell PLC 2011 A CLEAR STATEMENT OF THE DISSERTATION: The main purpose and the objective of the study are to study the financial and business analysis of ... objective of the company which has gathered the attention of the investors and the satisfaction and believe of the investors on the company 21 Business and Financial Analysis of BP with comparison to...

Ngày tải lên: 25/03/2014, 11:06

... contribute to spectral regrowth and how to control or correct them in order to keep the adjacent channel interference to within limits Spectral Analysis of Polynomial Nonlinearity 1837 −35 To utilize ... only corrects the AM/AM distortion of the PA Example 1, however, shows that one should be careful not to underestimate the effects of AM/PM distortion Of course, one has to evaluate the particular ... autocovariance function of x(t) as c2x (τ) We point out that (wide-sense) stationarity of x(t) is assumed in [1, 2, 3, 4, 6], often without justification The PSD of x(t) is defined as the FT of...

Ngày tải lên: 23/06/2014, 01:20

... vector of responses for animal, (i = 1, 2, , q) observed at times t1 , t2 , , tni test days As in the case of cross-sectional analysis, the binary response observed at a time t j related to ... advantage of a longitudinal analysis of sequential binary responses A random regression model proved to be superior than a model with constant genetic value over time based on the Bayes factor results ... longitudinal analysis of binary response data allows developing novel selection criteria other than a single predicted breeding value for liability to disease In this study, an approach to the analysis of...

Ngày tải lên: 14/08/2014, 13:22

... of cell types infected with a variety of strains of HIV-1, HSV-1, VZV and cytomegalovirus (CMV) compared to mock infected cells Results A range of cell lines and primary cells were infected with ... possible to identify a single housekeeping gene for use in QPCR studies of viral infections Nevertheless it is of benefit for researchers to be able to determine a shortlist of potential candidates To ... measures analysis of variance was then used to test for the presence of interaction between the effects of Page of (page number not for citation purposes) Virology Journal 2007, 4:130 the within...

Ngày tải lên: 18/06/2014, 18:20

... of cell types infected with a variety of strains of HIV-1, HSV-1, VZV and cytomegalovirus (CMV) compared to mock infected cells Results A range of cell lines and primary cells were infected with ... possible to identify a single housekeeping gene for use in QPCR studies of viral infections Nevertheless it is of benefit for researchers to be able to determine a shortlist of potential candidates To ... measures analysis of variance was then used to test for the presence of interaction between the effects of Page of (page number not for citation purposes) Virology Journal 2007, 4:130 the within...

Ngày tải lên: 20/06/2014, 01:20

... from the analysis of that event For trials in which only one of the groups had no event of interest, the estimate of treatment effect and its standard error were calculated after adding 0.5 to each ... investigator We also evaluated each trial for the adequacy of allocation concealment, performance of the analysis according to the intention -to- treat principle, and blind assessment of the outcomes of ... characteristics of these trials The age of the patients in the trials ranged from 59.3 to 66.6 years, and the length of followup ranged from 12.1 to 58.9 months Figure 1A shows the absolute numbers of deaths...

Ngày tải lên: 27/06/2014, 00:20

... Gy (V30), with NTCP and MLD SARP occurred in 45% and 37% of patients with MLD of more than 15 Gy and NTCP of 50% or more, respectively, whereas it occurred in 0% of patients with a MLD of 10 Gy ... minimized to avoid SARP We recommend to keep the value of V10 below 50%, so as to keep the incidence of SARP lower than 5.7% In conclusion, NTCP and V10 are useful indicators of risk for development of ... allowed us to focus on radiation dosimetric factors There are many reported studies [7,26,27,29-31] in which the risks of radiation pneumonitis were found to be associated with a variety of clinical...

Ngày tải lên: 09/08/2014, 08:23

... from 0.22 to 3.56 with a pooled odds ratio for all of the trials of 1.08 with a 95% confidence interval of 0.65 to 1.78 The test for heterogeneity was not statistically significant with p value ... diagnosed with DCIS for the first time, not recurrent or metastatic disease with no prior history of malignant disease (other than in situ carcinoma of the cervix, or BCC or SCC of skin) without ... recur or progress to invasive cancer when treated with excision alone [3,17-19] In this way, the aim of our meta -analysis is to summarizes the results of randomized trials performed, to evaluate the...

Ngày tải lên: 09/08/2014, 10:21

... regulatory committee refers to the eventual amount of benefit related to the addition of Bevacizumab For this reason, a cumulative analysis specifically designed to weight that became mandatory ... Magnitude of risks and benefits of the addition of bevacizumab to chemotherapy for advanced breast cancer patients: Meta-regression analysis of randomized trials Journal of Experimental & Clinical ... order to explore the magnitude of the benefit of adding Bevacizumab to chemotherapy for metastatic breast cancer with particular attention to safety, we conducted a meta -analysis Methods The analysis...

Ngày tải lên: 10/08/2014, 10:21

... interferon regulatory factor gene (IRF5) There are reports indicating that this gene can be associated with a subgroup of patients with rheumatoid arthritis [14-16] and patients with other autoimmune ... Gonzalez A: Association of interferon regulatory factor haplotypes, similar to that found in systemic lupus erythematosus, in a large subgroup of patients with rheumatoid arthritis Arthritis ... the recipient of an Instituto de Salud Carlos III predoctoral bursary MSG is the recipient of a Formacion de Profesorado Universitario predoctoral bursary from the Spanish Ministry of Education...

Ngày tải lên: 12/08/2014, 15:23

... provides clinical data on factors such as the presence of urinary tract infection, level of proteinuria on the day of surgery and 2–4 months later, and level of leucocytosis, which may have been of ... clinical signs with or without vaginal discharge and cystic endometrial hyperplasia with endometritis [26] Thirteen control dogs were selected from autopsy material submitted to the Section of ... Selected clinical data from the dogs with pyometra: Level of leucocytosis, presence of urinary tract infection as confirmed by culture of cysteocentesis urine during surgery, and level of urine...

Ngày tải lên: 12/08/2014, 18:21

... which is directly related with our outcome of interest, for this economic evaluation was “number of patients receiving clinical specialist services within a defined time of clinical specialists spent ... descriptions Sensitivity analysis was done to assess how the result of the analysis could change based on the values of some selected independent variables with a potential to change over time and across ... recomendations Clinical specialist outreach is found to be a cost effective and cost saving approach of using scarce clinical specialists for provision of clinical specialist services to people outside of...

Ngày tải lên: 13/08/2014, 11:22

... of treatment These were: (1) Duration of time until referral back to the primary sector or other health care provider (date of referral back minus date of first visit), (2) Number of visits to ... this point of view, our results were unambiguously in favour of the routine use of MRI for this type of patient To our knowledge, this is the first time the issue about the routine use of up-front ... economic consequences (because of the high cost of surgery) and negative personal consequences (because of the higher risk of serious side effects with surgery as compared with conservative treatment)...

Ngày tải lên: 13/08/2014, 14:20

... comparative trials, the maximal number of trials in one outcome was three Due to the low number of trials, no meaningful funnel plots could be produced Safety Four trials reported outcomes of adverse events ... this review, a total of 869 studies were screened out of which 148 studies with full texts were retrieved for selection according to the inclusion and exclusion criteria A total of 131 papers ... characteristics of the pregnant women (e.g age, ethnic group, term of pregnancy), a consensus protocol of the intervention, and clinical and end-point outcomes Trials should be reported according to the...

Ngày tải lên: 13/08/2014, 15:21

... Evidence and the Law, New York: Norton CHAPTER CUT COSTS AND INCREASE PROFITS CLINICAL TRIALS Clinical trials consist of a randomized comparison over a fixed period of time of an intervention method (drug, ... numbers of subjects (500 to 5000), studied over an extended period of time (2 to years) with the possibility of an even longer ongoing follow-up The larger number of subjects in this type of trial ... regulatory approval may well be increased by hiring regulators as paid consultants or providing them with stock options.4 Still, time spent battling with a regulatory agency is time wasted, as is time...

Ngày tải lên: 14/08/2014, 07:20

... lends itself to computerized analysis. 10 One or more clinical research monitors (CRMs) who along with the medical monitor will serve as the principal points of contact with study investigators and ... procedure During the trials and after, you will probably want to record the frequency of all adverse events, of specific adverse events, and of those events directly related to the intervention ... and timely monitoring of results To paraphrase Bernard Baruch regarding the stock market, “It’s best to put all one’s eggs in one basket, then watch the hell out of that basket.” Site Coordinators...

Ngày tải lên: 14/08/2014, 07:20

... response to intervention or of males and females or of smokers and nonsmokers, or on the basis of some other important cofactor, then you will want to randomize separately within each of the distinct ... monitoring to ensure protocol adherence at each site Other frequently observed blunders include absence of concealment of allocation in so-called blind trials, lack of justification for nonblind trials, ... journal articles offer advice on the design and analysis of clinical trials We group them here into three categories: General-purpose texts Texts that focus on the conduct of trials in specific...

Ngày tải lên: 14/08/2014, 07:20

... addition to the design team To maintain the validity of a fractional factorial design one has to be able to assume that the effect of Treatment A is the same at all levels of the cofactor and ... medical history, and social history data INITIAL SUBMISSION TO THE REGULATORY AGENCY Not surprisingly, the form of the protocol or investigational plan to be submitted to the regulatory agency ... or all of the following may be required depending on the requirements of your regulatory agency: List of investigators accompanied by copies of instructions provided to them List of laboratories...

Ngày tải lên: 14/08/2014, 07:20

... Total With ABC 45 39 Without 30 24 Total 75 14 63 32 300 26 294 58 594 Adverse Event Report Three types of interim adverse event reports are of interest: 1) frequency of specific adverse events ... participating in the clinical trials of your competitors To avoid problems, consult CenterWatch’s Drugs in Clinical Trials Database (http://www.centerwatch.com/professional/ cwpipeline/) or that of Current ... generally have experience only with smaller studies of more limited scope Industry-sponsored trials often entail a 30- to 50-page protocol in contrast to the 5- to 10-page protocols common in the academic...

Ngày tải lên: 14/08/2014, 07:20

... Choice of data management software and the options available to you Transfer of data from data entry to data storage and from data storage to your report generating and statistical analysis software ... provided for separate entries of each of half a dozen risk factors, with each factor further broken down into subcategories Smoking history, for example, was broken down into “never smoked,” “former ... investigator’s point of view, you know that a hotline needs to be part of the data entry process Ever have the experience of being told to call back the next day because the person on the other end of...

Ngày tải lên: 14/08/2014, 07:20