کد مقاله کد نشریه سال انتشار مقاله انگلیسی نسخه تمام متن
5549700 1556790 2017 5 صفحه PDF دانلود رایگان
عنوان انگلیسی مقاله ISI
Sharing some interim data in trial monitoring can mislead or unmask trial investigators: A scenario-based survey of trial experts
ترجمه فارسی عنوان
به اشتراک گذاری برخی از داده های موقت در نظارت بر محاکمه می تواند گمانه زنی ها را به گمراه کننده یا بازدارند: یک نظرسنجی مبتنی بر سناریو از کارشناسان محاکمه
موضوعات مرتبط
علوم پزشکی و سلامت داروسازی، سم شناسی و علوم دارویی علوم دارویی
چکیده انگلیسی

BackgroundSharing masked interim results by the Data Safety Monitoring Board (DSMB) with non-DSMB members is an important issue that can affect trial integrity. Our survey's objective is to collect evidence to understand how seemingly masked interim results or result extrapolations are interpreted and discuss whether these results should be shared at interim.MethodsConducted a 6 scenario-question survey asking trial experts how they interpreted three kinds of seemingly masked interim results or result extrapolation measures (interim combined event rate, adaptive conditional power and “unconditional” conditional power).ResultsThirty-one current Consolidated Standards of Reporting Trials group affiliates were invited for survey participation (February 2015). Response rate: 71.0% (22/31). About half, 52.6% (95% CI: 28.9%-74.0%), (10/19), correctly indicated that the interim combined event rate can be interpreted in three ways (drug X doing better than placebo, worse than placebo or the same) if shared at interim. The majority, 72.2% (95% CI: 46.5%-89.7%), (13/18), correctly indicated that the adaptive conditional power suggests relative treatment group effects. The majority, 53.3% (95% CI: 26.6%-77.0%), (8/15), incorrectly indicated that the “unconditional” conditional power suggests relative treatment group effects.Discussion/ConclusionKnowledge of these three results or result extrapolation measures should not be shared outside of the DSMB at interim as they may mislead or unmask interim results, potentially introducing trial bias. For example, the interim combined event rate can be interpreted in one of three ways potentially leading to mistaken guesswork about interim results. Knowledge of the adaptive conditional power by non-DSMB members is telling of relative treatment effects thus unmasking of interim results.

ناشر
Database: Elsevier - ScienceDirect (ساینس دایرکت)
Journal: Contemporary Clinical Trials Communications - Volume 7, September 2017, Pages 81-85
نویسندگان
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