Matches in SemOpenAlex for { <https://semopenalex.org/work/W1975292912> ?p ?o ?g. }
Showing items 1 to 86 of
86
with 100 items per page.
- W1975292912 abstract "Independent data monitoring committee is responsible for review of the ongoing safety of participants and the validity and integrity of data in clinical trials and for making recommendations to the sponsor whether the trial should continue as planned, be modified or be terminated because of safety concern, futility of the trial, or treatment benefit. Use of DMCs by government and industry sponsors has been growing steadily ever since the announcement by the US National Institutes of Health in 1998 and by the Food and Drug Administration in 2001 of policy and guidelines for data and safety monitoring.Since a statistical analysis plan serves as a benchmark for the final analysis and the final report for regulatory filing, it needs to be explicit about its contents including the specific statistical analyses to be used. An interim analysis plan, however, serves as a benchmark for the ongoing review of the safety and efficacy data by the DMC and therefore it cannot be codified as in an SAP as it needs to be flexible to address any concerns raised by the DMC during the trial and to evolve with the emerging issues in the monitoring of the study. More importantly it needs to summarize and present the interim safety and efficacy data in the most succinct way to facilitate the review of the ongoing risk-benefit of the trial and to help the DMC members comprehend the contents of the report in the most efficient way.Industry and contract research organization practices continue to be less than desirable in that there is a tendency to consider the interim analysis plan and resulting interim reports merely as a subset of the statistical analysis plan and the final report. This presentation will offer some thoughts on how the interim report should be prepared for DMC review and to improve the contents of the interim report." @default.
- W1975292912 created "2016-06-24" @default.
- W1975292912 creator A5001986524 @default.
- W1975292912 date "2011-12-01" @default.
- W1975292912 modified "2023-09-27" @default.
- W1975292912 title "Interim reports for data monitoring committee review vs final reports for regulatory filing" @default.
- W1975292912 doi "https://doi.org/10.1186/1745-6215-12-s1-a36" @default.
- W1975292912 hasPubMedCentralId "https://www.ncbi.nlm.nih.gov/pmc/articles/3287751" @default.
- W1975292912 hasPublicationYear "2011" @default.
- W1975292912 type Work @default.
- W1975292912 sameAs 1975292912 @default.
- W1975292912 citedByCount "1" @default.
- W1975292912 crossrefType "journal-article" @default.
- W1975292912 hasAuthorship W1975292912A5001986524 @default.
- W1975292912 hasBestOaLocation W19752929121 @default.
- W1975292912 hasConcept C112930515 @default.
- W1975292912 hasConcept C138885662 @default.
- W1975292912 hasConcept C142724271 @default.
- W1975292912 hasConcept C144133560 @default.
- W1975292912 hasConcept C166957645 @default.
- W1975292912 hasConcept C17744445 @default.
- W1975292912 hasConcept C195094911 @default.
- W1975292912 hasConcept C199539241 @default.
- W1975292912 hasConcept C2776505523 @default.
- W1975292912 hasConcept C2776957806 @default.
- W1975292912 hasConcept C2777488183 @default.
- W1975292912 hasConcept C2778137410 @default.
- W1975292912 hasConcept C39549134 @default.
- W1975292912 hasConcept C41895202 @default.
- W1975292912 hasConcept C535046627 @default.
- W1975292912 hasConcept C60644358 @default.
- W1975292912 hasConcept C61943457 @default.
- W1975292912 hasConcept C71924100 @default.
- W1975292912 hasConcept C73751289 @default.
- W1975292912 hasConcept C86803240 @default.
- W1975292912 hasConcept C95457728 @default.
- W1975292912 hasConceptScore W1975292912C112930515 @default.
- W1975292912 hasConceptScore W1975292912C138885662 @default.
- W1975292912 hasConceptScore W1975292912C142724271 @default.
- W1975292912 hasConceptScore W1975292912C144133560 @default.
- W1975292912 hasConceptScore W1975292912C166957645 @default.
- W1975292912 hasConceptScore W1975292912C17744445 @default.
- W1975292912 hasConceptScore W1975292912C195094911 @default.
- W1975292912 hasConceptScore W1975292912C199539241 @default.
- W1975292912 hasConceptScore W1975292912C2776505523 @default.
- W1975292912 hasConceptScore W1975292912C2776957806 @default.
- W1975292912 hasConceptScore W1975292912C2777488183 @default.
- W1975292912 hasConceptScore W1975292912C2778137410 @default.
- W1975292912 hasConceptScore W1975292912C39549134 @default.
- W1975292912 hasConceptScore W1975292912C41895202 @default.
- W1975292912 hasConceptScore W1975292912C535046627 @default.
- W1975292912 hasConceptScore W1975292912C60644358 @default.
- W1975292912 hasConceptScore W1975292912C61943457 @default.
- W1975292912 hasConceptScore W1975292912C71924100 @default.
- W1975292912 hasConceptScore W1975292912C73751289 @default.
- W1975292912 hasConceptScore W1975292912C86803240 @default.
- W1975292912 hasConceptScore W1975292912C95457728 @default.
- W1975292912 hasLocation W19752929121 @default.
- W1975292912 hasLocation W19752929122 @default.
- W1975292912 hasLocation W19752929123 @default.
- W1975292912 hasOpenAccess W1975292912 @default.
- W1975292912 hasPrimaryLocation W19752929121 @default.
- W1975292912 hasRelatedWork W1574428548 @default.
- W1975292912 hasRelatedWork W1985381229 @default.
- W1975292912 hasRelatedWork W2027194507 @default.
- W1975292912 hasRelatedWork W2033507790 @default.
- W1975292912 hasRelatedWork W2057495199 @default.
- W1975292912 hasRelatedWork W2058243926 @default.
- W1975292912 hasRelatedWork W2068716177 @default.
- W1975292912 hasRelatedWork W2071194119 @default.
- W1975292912 hasRelatedWork W2077413655 @default.
- W1975292912 hasRelatedWork W2117325009 @default.
- W1975292912 hasRelatedWork W2132513819 @default.
- W1975292912 hasRelatedWork W2132771395 @default.
- W1975292912 hasRelatedWork W2138883806 @default.
- W1975292912 hasRelatedWork W2145308289 @default.
- W1975292912 hasRelatedWork W2168966365 @default.
- W1975292912 hasRelatedWork W2256971346 @default.
- W1975292912 hasRelatedWork W2319836295 @default.
- W1975292912 hasRelatedWork W2593222159 @default.
- W1975292912 hasRelatedWork W3196998738 @default.
- W1975292912 hasRelatedWork W66121610 @default.
- W1975292912 isParatext "false" @default.
- W1975292912 isRetracted "false" @default.
- W1975292912 magId "1975292912" @default.
- W1975292912 workType "article" @default.