Real life outcomes vs. clinical trial results

Two questions that clinicians should answer as they attempt to apply the results of clinical trials to clinical practice are: (1) will statistically significant results be reproduced in their clinical practice; and (2) if nothing goes wrong in a clinical trial, is everything alright? Regarding the f...

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Main Author: Marco Zarbin
Format: Article
Language:English
Published: Knowledge E 2019-01-01
Series:Journal of Ophthalmic & Vision Research
Subjects:
Online Access:http://www.jovr.org/article.asp?issn=2008-322X;year=2019;volume=14;issue=1;spage=88;epage=92;aulast=Zarbin
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author Marco Zarbin
author_facet Marco Zarbin
author_sort Marco Zarbin
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description Two questions that clinicians should answer as they attempt to apply the results of clinical trials to clinical practice are: (1) will statistically significant results be reproduced in their clinical practice; and (2) if nothing goes wrong in a clinical trial, is everything alright? Regarding the first question, when considering the results of a randomized, multicenter, prospective, controlled clinical trial, two questions that cannot be addressed by simply by reading the trial results and that only the practicing clinician can answer are: (1) is the study population representative of the patient about to be treated; and (2) is the totality of evidence outside the trial (including the clinician's own extensive experience) consistent with the trial result? Regarding the second question, clinicians are advised to recognize that most studies, even Phase 3 trials, are underpowered to accurately assess the risk of low frequency events.
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spelling doaj.art-4060c727bae54292b94aa1496a0685622022-12-22T04:33:33ZengKnowledge EJournal of Ophthalmic & Vision Research2008-322X2019-01-01141889210.4103/jovr.jovr_279_18Real life outcomes vs. clinical trial resultsMarco ZarbinTwo questions that clinicians should answer as they attempt to apply the results of clinical trials to clinical practice are: (1) will statistically significant results be reproduced in their clinical practice; and (2) if nothing goes wrong in a clinical trial, is everything alright? Regarding the first question, when considering the results of a randomized, multicenter, prospective, controlled clinical trial, two questions that cannot be addressed by simply by reading the trial results and that only the practicing clinician can answer are: (1) is the study population representative of the patient about to be treated; and (2) is the totality of evidence outside the trial (including the clinician's own extensive experience) consistent with the trial result? Regarding the second question, clinicians are advised to recognize that most studies, even Phase 3 trials, are underpowered to accurately assess the risk of low frequency events.http://www.jovr.org/article.asp?issn=2008-322X;year=2019;volume=14;issue=1;spage=88;epage=92;aulast=ZarbinClinical Practice; Clinical Trial; Confidence Interval; P value; Rule of Three; Statistical Significance
spellingShingle Marco Zarbin
Real life outcomes vs. clinical trial results
Journal of Ophthalmic & Vision Research
Clinical Practice; Clinical Trial; Confidence Interval; P value; Rule of Three; Statistical Significance
title Real life outcomes vs. clinical trial results
title_full Real life outcomes vs. clinical trial results
title_fullStr Real life outcomes vs. clinical trial results
title_full_unstemmed Real life outcomes vs. clinical trial results
title_short Real life outcomes vs. clinical trial results
title_sort real life outcomes vs clinical trial results
topic Clinical Practice; Clinical Trial; Confidence Interval; P value; Rule of Three; Statistical Significance
url http://www.jovr.org/article.asp?issn=2008-322X;year=2019;volume=14;issue=1;spage=88;epage=92;aulast=Zarbin
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