Clinical and statistical significance

    • [DOC File]Quick Tips to Identifying High Quality Research

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      Statistical significance AND clinical significance In brief, statistical significance means that there is a real relationship involved in whatever it is the researchers measured. For example, people who get counseling really are less depressed than those who do not.

    • [DOCX File]ClinicalTrials

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      The ClinicalTrials.gov trial registry was released for the registration of studies on February 29, 2000. The database downloaded by the Clinical Trials Transformation Initiative (CTTI) and the Duke Clinical Research Institute (DCRI) on March 27, 2016 includes 211,437 studies.

    • [DOC File]Microsoft Word - Bioequivalence Study Reporting Format

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      8.3. Clinical and Safety Records Adverse Event(s) Drug-related Adverse Drug Reaction(s) 8.4 Pharmacokinetic Parameters and Tests Definitions and Calculation 8.5 Statistical Analyses Log-transformed Data Analysis (AUC, Cmax) Sampling Time Adjustments t max t½ Acceptance Criteria for Bioequivalence ANOVA Presentation Power

    • [DOC File]GHTF SG5 Clinical Evaluation - IMDRF

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      Statistical significance Has a statistical analysis of the data been provided and is it appropriate? S1. S2. Yes. No Clinical significance Was the magnitude of the treatment effect observed clinically significant? C1. C2 Yes. No . Appendix E: A Possible Format for a Clinical Evaluation Report. General details

    • [DOC File]Domain 2: Biostatistical Applications— “Case-based” Lecture

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      State the appropriate type of statistical test to use for a given type of data and trial design. Interpret the clinical and statistical significance of p-values and/or confidence intervals. Describe areas of misuse or misrepresentation that are associated with various statistical methods. Self-assessment Questions: 1.

    • [DOC File]1.5 Nutrition Research Statistics.docx

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      Statistical Significance is represented by p-values in most research. The p-value is an estimate of whether the difference is a statistical accident or due to random chance. A p-value of less than 0.05 (commonly written p-value

    • [DOC File]Clinical Device Protocol Template - ou h

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      A summary of findings from non-clinical studies (if relevant) that potentially have clinical significance and from other clinical trials relevant to this trial). Summary of the known and potential risks and benefits, if any, to human participants.

    • [DOC File]Checklist of statistical adequacy - Elsevier

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      Assumptions of statistical tests should be verified and confirmed validity noted in the text. If transformations are applied, they should be described. Authors should verify that the transformations achieved the desired results. Specify and defend the criterion used to determine both statistical and clinical significance.

    • [DOC File]Statistical Guidelines

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      Annals of Clinical Biochemistry Statistical Guidelines. These guidelines are designed to help authors prepare statistical data for publication and are not a substitute for the detailed guidance required to design a study or perform a statistical analysis.

    • [DOCX File]Tool Summary Sheet: Clinical Monitoring Plan Template

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      The CROMS statistical programmer will randomly select participant files for CRA review at each interim visit. Once selected, these participants will be monitored through the entirety of their participation in the study. ... Verify that the PI assessed all abnormal lab values for clinical significance ...

    • [DOC File]Clinical Research Protocol - Duke University

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      Statistical Plan 7. 7.1 Sample Size Determination 7. 7.2 Statistical Methods 7. 7.3 Subject Population(s) for Analysis 7. 8. Safety and Adverse Events 7. ... Summarize the available non-clinical data (published or available unpublished data) that could have clinical significance. Clinical Data to Date. Summarize the available clinical study ...

    • [DOC File]Probabilities of Clinical or Practical Significance

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      ) that I am using for a seminar with the title Statistical vs Clinical or Practical Significance. The presentation includes the following points: An outline of the meaning and shortcomings of hypothesis testing, P values and statistical significance. The meaning and need for likely (confidence) limits to convey precision of estimation.

    • [DOC File]Clinical Research Protocol - UC Davis Health

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      Statistical Plan 6. 7.1 Sample Size Determination 6. 7.2 Statistical Methods 6. 7.3 Subject Population(s) for Analysis 6. 8. Safety and Adverse Events 6. ... Summarize the available non-clinical data (published or available unpublished data) that could have clinical significance. Clinical Data to Date. Summarize the available clinical study ...

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