Abstract

TheArrestRespiratoryFailureduetoPneumonia(ARRESTPNEUMONIA)DataCoordinating Center(DCC)willfulfillanessentialneedtoensurethattheARRESTPneumoniatrialwill achieveitsmissiontoestablishtheefficacyofancillarytherapydirectlytargetingthelunginjury thatoccurswithpneumonia.Criticaltocarryingoutthetrial?ssuccessisDCCoversightofthe implementationofthestudydesignandrandomizationscheme,performingtheinterimandfinal dataanalysis,regulardataandsafetymonitoringreports,thetimelydisseminationoffindings, anddataandresourcesharing.Tomeetitsgoals,theDCCwillemployopen-sourcesecure web-basedtoolssuchasREDCapforhousingdataacrossthe10sitesandallowingweb-based randomization;?appropriatestatisticaltechniques,includingmethodsfortheanalysisoftime-to- eventdatainthepresenceofcompetingrisks;?andexpertiseinclinicaltrialdesignanddata safetymonitoring.TheDCCincludesastellarteamwithextensiveexperienceininnovative clinicaltrialdesigns,statisticalmodeling,managinglargeandcomplexdatasets,andmonitoring dataquality.Importantly,theoperationoftheDCCwillrelyheavilyonthephilosophythatDCC membersshouldbefullyintegratedintothetrial?sresearchteamaswellasintheinfrastructural supportinordertooptimallymeetthetrialsdata-relatedandcoordinationneeds.Tothatend, theDCCiscomposedoffivesupportteamscorrespondingtokeysupportfunctionsofa biostatisticsanddatacoordinatingcenter.TheDCC?sstructurewillensurethesuccessofthe scientificgoalsforARRESTPneumoniabydesigningandmonitoringthetrial,developinga databaseinREDCap,providingspecificexpertiseonsafetymonitoringandqualitycontrol, implementinganalyses,andprovidingprincipalinterpretationfordissemination.

Public Health Relevance

/ScientificRelevance CriticaltoachievingthescientificmissionoftheArrestRespiratoryFailureduetoPneumonia (ARRESTPneumonia)trialistheoversightoftheimplementationofthestudydesign,regular dataandsafetymonitoringreports,andthetimelydisseminationoffindings.TheARREST PneumoniaDCCwillmeettheseessentialneedsbyemployingopen-sourcesecureweb-based toolssuchasREDCapforhousingdataacrossthe10sitesandallowingweb-based randomization;?appropriatestatisticaltechniques,includingmethodsfortheanalysisoftime-to- eventdatainthepresenceofcompetingrisks;?andexpertiseinclinicaltrialdesignanddata safetymonitoring.TheARRESTPneumoniaDCCwillensurethesuccessofthescientificgoals forARREST,whicharestronglyalignedwiththegoalsoftheNHLBI,bydesigningand monitoringthetrial,developingadatabaseinREDCap,providingspecificexpertiseonsafety monitoringandqualitycontrol,implementinganalyses,andprovidingprincipalinterpretationfor dissemination.

  Funding Agency

Agency
National Institute of Health (NIH)
Institute
National Heart, Lung, and Blood Institute (NHLBI)
Type
Resource-Related Research Projects--Cooperative Agreements (U24)
Project #
5U24HL141727-02
Application #
10009410
Study Section
Clinical Trials Review Committee (CLTR)
Program Officer
Reineck, Lora A
Project Start
2019-09-15
Project End
2024-08-31
Budget Start
2020-09-01
Budget End
2021-08-31
Support Year
2
Fiscal Year
2020
Total Cost
Indirect Cost

  Institution

Name
Stanford University
Department
Internal Medicine/Medicine
Type
Schools of Medicine
DUNS #
009214214
City
Stanford
State
CA
Country
United States
Zip Code
94305