scholarly journals Reply to “Why Secondary Analyses in Vitamin D Clinical Trials Are important and How to Improve Vitamin D Clinical Trial Outcome Analyses—A Comment on “Extra-Skeletal Effects of Vitamin D”, Nutrients 2019, 11, 1460”

Nutrients ◽  
2019 ◽  
Vol 11 (9) ◽  
pp. 2188 ◽  
Author(s):  
Madhusmita Misra ◽  
Rose Marino
Keyword(s):  
Clinical Trial ◽  
Vitamin D ◽  
Clinical Trials ◽  
Trial Outcome ◽  
Clinical Trial Outcome ◽  
Secondary Analyses ◽  
Skeletal Effects

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scholarly journals Need for Outcome Scenario Analysis of Clinical Trials in Diabetes

2016 ◽  
Vol 11 (2) ◽  
pp. 327-334 ◽  
Author(s):  
Rosa Garcia-Verdugo ◽  
Michael Erbach ◽  
Oliver Schnell
Keyword(s):  
Clinical Trial ◽  
Decision Making ◽  
Clinical Trials ◽  
Theoretical Model ◽  
Scenario Analysis ◽  
Cardiovascular Safety ◽  
Time Cost ◽  
Phase 3 ◽  
Trial Outcome ◽  
Clinical Trial Outcome

Since the FDA requirement for cardiovascular safety of all new antihyperglycemic drugs to enter the market, the number and extent of phase 3 clinical trials has markedly increased. Unexpected trial results imply an enormous economic, personal and time cost and has deleterious effects over R&D. To prevent unforeseen developments in clinical trials, we recommend performing a comprehensive prospective outcome scenario analysis before launching the trial. In this commentary, we discuss the most important factors to take in consideration for prediction of clinical trial outcome scenarios and propose a theoretical model for decision making.

Outcome Domains and Measures in Total Joint Replacement Clinical Trials: Can We Harmonize Them? An OMERACT Collaborative Initiative

2015 ◽  
Vol 42 (12) ◽  
pp. 2496-2502 ◽  
Author(s):  
Jasvinder A. Singh ◽  
Michael Dohm ◽  
Andrew P. Sprowson ◽  
Peter D. Wall ◽  
Bethan L. Richards ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Clinical Trials ◽  
Patient Satisfaction ◽  
Joint Replacement ◽  
Working Group ◽  
Total Joint Replacement ◽  
Core Domain ◽  
Trial Outcome ◽  
Clinical Trial Outcome ◽  
Core Domain Set

Objective.To develop a plan for harmonizing outcomes for people undergoing total joint replacement (TJR), to achieve consensus regarding TJR outcome research.Methods.The TJR working group met during the 2014 Outcome Measures in Rheumatology (OMERACT) 12 meeting in Budapest, Hungary. Multiple conference calls preceded the face-to-face meeting. Brief presentations were made during a 1.5-h meeting, which included an overview of published systematic reviews of TJR trials and the results of a recent systematic review of TJR clinical trial outcome domains and measures. This was followed by discussion of potential core set areas/domains for TJR clinical trials (as per OMERACT Filter 2.0) as well as the challenges associated with the measurement of these domains.Results.Working group participants discussed which TJR clinical trial outcome domains/areas map to the inner versus outer core for core domain set. Several challenges were identified with TJR outcomes including how to best measure function after TJR, elucidating the source of the pre- and post-TJR joint pain being measured, joint-specific versus generic quality of life instruments and the importance of patient satisfaction and revision surgery as outcomes. A preliminary core domain set for TJR clinical trials was proposed and included pain, function, patient satisfaction, revision, adverse events, and death. This core domain set will be further vetted with a broader audience.Conclusion.An international effort with active collaboration with the orthopedic community to standardize key outcome domains and measures is under way with the TJR working group. This effort will be further developed with new collaborations.

Relationship between placebo response rate and clinical trial outcome in bipolar depression

2016 ◽  
Vol 74 ◽  
pp. 38-44 ◽  
Author(s):  
Nadia Iovieno ◽  
Andrew A. Nierenberg ◽  
Susannah R. Parkin ◽  
Daniel Ju Hyung Kim ◽  
Rosemary S.W. Walker ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Response Rate ◽  
Bipolar Depression ◽  
Placebo Response ◽  
Placebo Response Rate ◽  
Trial Outcome ◽  
Clinical Trial Outcome
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