scholarly journals Hormesis in tartrazine allergic responses of atopic patients: An overview of clinical trials and a raw data revision

2020 ◽  
Vol 5 (3) ◽  
pp. 59
Author(s):  
LuizQuerino De Araújo Caldas ◽  
FláviaPeixoto Caldas Marmo ◽  
PatríciaLusié Velozo da Costa ◽  
Ludmillada Silva Viana Jacobson
Keyword(s):  
Clinical Trials ◽  
Raw Data ◽  
Data Revision

Transformations of Variables in Clinical-Therapeutical Research

1962 ◽  
Vol 1 (02) ◽  
pp. 38-50 ◽  
Author(s):  
L. Martin
Keyword(s):  
Clinical Trials ◽  
Recurrent Events ◽  
Distribution Functions ◽  
Theory And Practice ◽  
Frequency Function ◽  
Raw Data ◽  
Homogeneous Population ◽  
Percentile Method ◽  
Rr Interval ◽  
Probability Paper

When the clinician gets the figures of body measurements or laboratory and functional tests, he has to see if the results fall into the range of normal variability or outside. This may only be defined by reference to an alleged homogeneous population whose description implies statistical tools in order to specify the distribution of clinical features. In clinical-therapeutical research like clinical trials, a more elaborate knowledge of the kind of distributions of the characters under study is needed. Very often, for the validity of the statistical calculations, the raw data will not be used as such and appropriate transformations of the data will be used.After recalling the importance of distribution functions in clinical research, the author gives the 1—99 or 2,5—97,5 percentile method of assessing the cases normally belonging to the population. The scale of coefficient of variation of clinical measurements goes from 0,5 % for the basal temperature to 65 % for the minimal effective dosis of digitalics.To ensure the legality of statistical reduction of data and analysis, such as analysis of variance, it is often necessary to perform transformations of raw data. Some of these lead to useful graphical representations on special papers.For continuous variables such as height, the author considers the probit transfpr-mation of percentages. The r ankit is used in the case of ordinal data. The logarithmic transformation of data such as body weight, survival time in leukaemia and other cancers, gives straight lines after probit transformation of the cumulated percentages.For discontinuous variables or bi nomial variab 1 e s such as counts of improved patients by several treatments, the angular transformation gives a clear graphical representation of the results of clinical trials (binomial probability paper).In biological assay, probits and logits are widely used. For Poisson variables like Thoma’s chamber and radioactive counts, the root square transformation is appropriate. A Poisson-sum probability paper allows a quick graphic test of the Poisson distribution.Finally, for recurrent events such as the RR interval in ECG of complete arrhythmia by auricular fibrillation, the concept of imminence (MACREZ) of occurrence of a further systole involves a simple transformation of the frequency function of the RR interval and allows an easier dissection of this frequency function in several components.In conclusion the author shows the necessity for the research clinician to have a good training in mathematics, statistics, sampling theory and practice and emphasizes the interest of collaboration amongst clinicians both at national and international levels.

Raw data from clinical trials: within reach?

2013 ◽  
Vol 34 (12) ◽  
pp. 645-647 ◽  
Author(s):  
Peter Doshi ◽  
Steven N. Goodman ◽  
John P.A. Ioannidis
Keyword(s):  
Clinical Trials ◽  
Raw Data

Statin wars: have we been misled about the evidence? A narrative review

2018 ◽  
Vol 52 (14) ◽  
pp. 905-909 ◽  
Author(s):  
Maryanne Demasi
Keyword(s):  
Clinical Trials ◽  
Heart Disease ◽  
Low Risk ◽  
Healthy People ◽  
Public Confidence ◽  
Efficacy And Safety ◽  
Cholesterol Lowering ◽  
Raw Data ◽  
The World ◽  
Total Sales

Statins are the most widely prescribed, cholesterol-lowering drugs in the world. Despite the expiration of their patents, revenue for statins is expected to rise, with total sales on track to reach an estimated US$1 trillion by 2020. A bitter dispute has erupted among doctors over suggestions that statins should be prescribed to millions of healthy people at low risk of heart disease. There are concerns that the benefits have been exaggerated and the risks have been underplayed. Also, the raw data on the efficacy and safety of statins are being kept secret and have not been subjected to scrutiny by other scientists. This lack of transparency has led to an erosion of public confidence. Doctors and patients are being misled about the true benefits and harms of statins, and it is now a matter of urgency that the raw data from the clinical trials are released.

Treatment-related hypertension (HTN) as a predictive biomarker for clinical outcomes in patients (pts) with advanced pancreas cancer (APCA) treated with bevacizumab (B): A pooled analysis of four prospective clinical trials.

2013 ◽  
Vol 31 (4_suppl) ◽  
pp. 239-239
Author(s):  
Ludmila Katherine Martin ◽  
Lai Wei ◽  
Katherine Van Loon ◽  
Renuka V. Iyer ◽  
Shubham Pant ◽  
...  
Keyword(s):  
Clinical Trials ◽  
Clinical Outcomes ◽  
Predictive Biomarkers ◽  
Pooled Analysis ◽  
Phase Iii ◽  
Phase Ii Trials ◽  
Grade Group ◽  
Raw Data ◽  
Group 2 ◽  
Group 1

239 Background: Phase III studies of B in unselected APCA pts have been negative. Recent data suggest subsets of pts may benefit from B, but no validated predictive biomarkers exist for B efficacy in APCA. The pathogenesis of B-related HTN (B-HTN) is not well understood, but studies suggest association between B-HTN and improved clinical outcome in various advanced solid tumors. We conducted a pooled analysis of raw data from 4 prospective clinical trials to evaluate that predictive role of B-HTN in APCA. Methods: Relevant raw data were collected from 4 multi-institution single-arm phase II trials of GEM-based doublet chemotherapy + B as 1st line treatment of APCA. Pts were grouped according to B-HTN of any grade (Group 1) and no B-HTN (Group 2). Clinical outcomes including OS, TTP, ORR, and DCR (disease control rate = ORR + SD >16 weeks) were compared between Group 1 and 2. For pts in Group 1, outcomes were also compared according to CTCAE HTN grade (1-2 vs 3-4). Results: 166 pts (85 M, 81 F) with median age 55 (31-85) were included. Group 1= 37 pts (Grade 1-2 HTN, N=18; Grade 3-4 HTN, N=19), Group 2 = 129 pts. Demographics were similar except % stage 4 (92% group 1, 100% group 2, p=0.01). Results are summarized in the Table. Group 1 had significantly prolonged mOS and mTTPand improved ORR and DCR vs Group 2. There was no difference in outcome according to HTN grade. Conclusions: B-HTN of any grade may be an important pharmacodynamic biomarker for B in APCA. This subset of pts could benefit from B and identification of characteristics that predict development of B-HTN may aid in future pt selection for B therapy in APCA. Future prospective studies may consider pharmacodynamic titration of B to grade > 1 HTN to potentially maximize B efficacy. [Table: see text]

Experiences of designing a data base for clinical trials information using an English language database management system

1980 ◽  
Vol 2 (6) ◽  
pp. 299-306 ◽  
Author(s):  
Pamela de Rivaz ◽  
Pamela North
Keyword(s):  
Clinical Trials ◽  
Data Base ◽  
Management System ◽  
Database Management ◽  
English Language ◽  
Database Management System ◽  
Network Structures ◽  
Raw Data ◽  
Hierarchical Tree

The problems encountered using a manual system to manage data generated by clinical trials at Smith Kline and French, are highlighted. The development of a computer sys tem for handling clinical trials' data, using database tech niques, is presented. The problems encountered and the bene fits gained from using both hierarchical tree and network structures are discussed. The disciplines enforced by a com puter system necessitated some changes in the design of the documents used to record the raw data. These changes are described. About half of the clinical trials' data are quali tative or textual, and the problems inherent in computerising this type of data and their solutions are presented.

Localization of Gallium-67 in Peritoneal Cells by Electron Microscopic Autoradiography

1973 ◽  
Vol 31 ◽  
pp. 404-405
Author(s):  
D. C. Swartzendruber ◽  
Norma L. Idoyaga-Vargas
Keyword(s):  
Clinical Trials ◽  
Soft Tissue ◽  
Tumor Tissue ◽  
Soft Tissue Tumors ◽  
Clinical Usefulness ◽  
Electron Microscopic ◽  
Normal Cells ◽  
Electron Microscopic Autoradiography ◽  
Peritoneal Cells ◽  
Gallium 67

The radionuclide gallium-67 (67Ga) localizes preferentially but not specifically in many human and experimental soft-tissue tumors. Because of this localization, 67Ga is used in clinical trials to detect humar. cancers by external scintiscanning methods. However, the fact that 67Ga does not localize specifically in tumors requires for its eventual clinical usefulness a fuller understanding of the mechanisms that control its deposition in both malignant and normal cells. We have previously reported that 67Ga localizes in lysosomal-like bodies, notably, although not exclusively, in macrophages of the spocytaneous AKR thymoma. Further studies on the uptake of 67Ga by macrophages are needed to determine whether there are factors related to malignancy that might alter the localization of 67Ga in these cells and thus provide clues to discovering the mechanism of 67Ga localization in tumor tissue.

Rome I versus Rome II; Overlap in patients enrolled in tegaserod phase III clinical trials for irritable bowel syndrome (IBS)

2001 ◽  
Vol 120 (5) ◽  
pp. A284-A284
Author(s):  
B NAULT ◽  
S SUE ◽  
J HEGGLAND ◽  
S GOHARI ◽  
G LIGOZIO ◽  
...  
Keyword(s):  
Clinical Trials ◽  
Irritable Bowel Syndrome ◽  
Phase Iii ◽  
Phase Iii Clinical Trials ◽  
Irritable Bowel ◽  
Rome I
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