Creating Clinical Research Protocols in Advanced Practice: Part III, Building Blocks of Study Design

2017 ◽  
Vol 28 (1) ◽  
pp. 74-83 ◽  
Author(s):  
Jill Engel ◽  
Lynn McGugan ◽  
Myra Ellis
2017 ◽  
Vol 28 (2) ◽  
pp. 210-217
Author(s):  
Myra Ellis ◽  
Lynn McGugan ◽  
Jill Engel ◽  
Bradi B. Granger

Author(s):  
Fengyu Zhang ◽  
Claude Hughes

Transparency in reporting the results of clinical and preclinical research is critical for unbiased publications. Funding agencies, publishers, and regulators have the responsibility to advocate and implement reporting standards for rigorous design. While individual study protocols may have included these standards, the items reported in the respective publications have often been inconsistent or lack transparency. This editorial intends to provide some specific guidelines for reporting results of clinical research with standards required for rigorous study design. We recommend that reporting clinical research should include sufficient information on study design and analysis plan that contains data processing, quality assurance, and appropriate methods used for rigorous statistical analysis or modeling. Any discrepancy between publications and original study design should be disclosed and discussed. Additionally, recent advances in the analysis of outcome with repeated measurements and statistical modeling should be employed to obtain unbiased estimates. Finally, we briefly discuss some issues reporting real-world evidence in clinical research.


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