PCORI INTERIM PROGRESS REPORT - Biostatistics · Updated on Friday, February 12, 2016 PCORI INTERIM...

PrincipalInvestigator(Scharfstein,Daniel,Oscar)

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Updated on Friday, February 12, 2016

PCORI INTERIM PROGRESS REPORT Use continuation pages as needed. Limit 20 pages, not including the Certification page.

Date(mm/dd/yyyy):7/31/2016

TitleofProject:Sensitivity Analysis Tools for Clinical Trials with Missing Data

PeriodCoveredbythisReport:2/1/2015to7/31/2016

IterationofProgressReport:�6-month�12-month�18-month�24-month�30-month

�Other(specifyhere)

PrincipalInvestigator&InstitutionUpdatedContactInformation:

PIFirstName: Daniel

PILastName: Scharfstein

PIEmail: [email protected]

PIOfficePhone: 410-955-2420

AOFirstName: Ashley

AOLastName: Hoover

AOEmail: [email protected]

AOOfficePhone: 443-997-1935

InstitutionLegalName: JohnsHopkinsUniversity

Address(street,city,

state,zipcode):

615NorthWolfeStreet

Baltimore,MD21205

Telephone: 410-955-3067

KeyPatientandOtherStakeholderPartnerContactInformation(uptothree):

Name:

Telephone/Email:

Name:

Telephone/Email:

Name:

Telephone/Email:


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MILESTONES UPDATE

Recordeachmilestonelabel,name,description,andprojectedcompletiondate(columnsA-D),asshowninAttachmentB(MilestoneSchedule)ofyourContract.CompleteColumnsE,F,andGformilestonesdueorcompletedduringthecurrentreportingperiod.ColumnE:Checkappropriateboxindicatingmilestonecompletionstatusduringreportingperiod.Additionalinformationonmilestonesthatwerenotcompletedisrequiredandshouldbeprovidedinthesectionbelowthistable.ColumnF:Selectactualdateofmilestonecompletion.ColumnG:Ifapplicable,selectappropriatereasonfordelay/non-completionofprojectedmilestoneduringthespecifiedreportingperiod.ColumnA ColumnB ColumnC ColumnD ColumnE ColumnF ColumnGMilestoneLabel

(e.g.,B-1,etc.)

MilestoneName DescriptionProjectedCompletion

Date

Completed?(Yes/No)

DateCompleted

IfNotCompleted,ReasonforDelay

B-1 Website Expandregistrationonwebsitetoinclude

PCOresearchers

7/31/2014 Yes No 10/31/2014

Chooseanitem.

B-2 AdvisoryBoard ConveneMeeting 7/31/2014 Yes No 7/21/2014 Chooseanitem.

C SubmitInterimProgressReport

InterimProgressReport

7/31/2014 Yes No 7/31/2014 Chooseanitem.

D-1 Casestudies/trainingmaterials

CreatePCO-centeredcasestudyand

trainingmaterials


D-2 Shortcourses Facilitatetwoshortcourses


D-3 Adobeconnectsession Adobeconnectsessionwithusers



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ColumnA ColumnB ColumnC ColumnD ColumnE ColumnF ColumnGMilestoneLabel

(e.g.,B-1,etc.)


Date

Completed?(Yes/No)

DateCompleted


D-4 Manuscriptformonotonemissingdata

SubmitcasestudytoPCORfocusedjournal

1/31/2015 Yes No 10/31/2016 Chooseanitem.TechnicalIssues

E SubmitInterimProgressReport



F AdvisoryBoard ConveneMeeting 7/31/2015 Yes No 11/31/2015 Chooseanitem.

G SubmitInterimProgressReport



H1 Casestudies/trainingmaterials

CreatePCO-centeredcasestudyand

trainingmaterials

1/31/2016 Yes No 9/30/2016 Chooseanitem.TechnicalIssues

H2 Shortcourses Facilitatetwoshortcourses


H3 Adobeconnectsession Adobeconnectsessionwithusers


H4 Manuscriptfornon-monotonemissingdata

SubmitcasestudytoPCORfocusedjournal

1/31/2016 Yes No 11/30/2016 Chooseanitem.Drafted,Waitingformainmanuscripttobeaccepted

I SubmitInterimProgressReport



J AdvisoryBoard ConveneMeeting 7/31/2016 Yes No Clickheretoenteradate.

Chooseanitem.

K SubmitInterimProgressReport


7/31/2016 Yes No Clickheretoenteradate.

Chooseanitem.


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ColumnA ColumnB ColumnC ColumnD ColumnE ColumnF ColumnGMilestoneLabel

(e.g.,B-1,etc.)


Date

Completed?(Yes/No)

DateCompleted


Clickheretoenteradate.

Yes No Clickheretoenteradate.

Chooseanitem.

Clickheretoenteradate.

Yes No Clickheretoenteradate.

Chooseanitem.


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RECRUITMENT, ENROLLMENT, AND RETENTION UPDATE Instructionsforcompletingrecruitment,enrollment,andretentionTable1andSiteInformation• Completerecruitmenttablesandsiteinformationateveryreportingperiod.Reportcumulative

informationateachreportingtimeperiod.CompleteaseparateTable1andrequestedsiteinformationforeachdistinctprojectactivitythatinvolvesrecruitmentandenrollmentofstudyparticipants.Eachofthefollowingmaybedistinct:

o Prospectivetrialso Observationalstudieso Focusgroupso In-depthinterviewso Surveyso Recruitmentofdifferentparticipantpopulations(e.g.,patients,providers,caregivers)

foranyoftheaboveactivities

Example:Ifyourprojectconductsin-depthinterviewswithclinicians,thenconductssurveyswithpatients,andthenconductsarandomized-controlledtrialenrollingpatients,thenyouneedtocompletethreetablesandprovidetherequestedSiteInformationforeachprojectactivity.

Table1CumulativeRecruitment,Enrollment,andRetentionofStudyParticipants

ProjectActivity(e.g.,in-depthinterviews,patientfocusgroups,prospectivetrial):________Participantpopulation(e.g.,patients,caregivers,clinicians):________________

ColumnA ColumnB

ColumnC ColumnD ColumnE ColumnF

Column

G


Projectmonths

Dateofupdate

PlannedSampleSize

TotalScreened(N)

TotalEligible(N)

TotalEnrolled(N)

TotalLosttoFollow-up(N)

%Losttofollow-up

6-month 0–6months

12-month 7-12months

18-month 13-18months



36-month 31–36months


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KEYColumnA:DateofupdateColumnB:Samplesize(numberofindividualsyouplantoenroll)inyourapprovedresearchplan.Forgroup-leveldatasuchasafocusgroup,enterthenumbersofgroups,notthenumberofparticipantsforeachgroup.ColumnC:Totalnumberofindividualsscreenedforeligibilitytodate.Thisisthenumberapproachedand/ortested(e.g.,labtests,reviewofmedicalhistory,survey,etc.)todeterminepotentialeligibilityfortheproject.ColumnD:Ofthescreenedindividuals,totalnumberofindividualswhomettheeligibilitycriteriatodateColumnE:Oftheeligibleindividuals,totalnumberofparticipantsenrolledtodateColumnF:Numberofparticipantsthathavebeenlosttofollow-up(enterN/Aifnotapplicabletoyourproject)ColumnG:Percentlosttofollow-up=Numberlosttofollow-up/totalnumberenrolled*100SiteInformation• Numberofsites,clinicsand/orpracticesfromwhichyouwillrecruitstudyparticipants?

____________.Ifyouarerecruitingstudyparticipantsfromsourcesthatarenotsitespecific(e.g.,websites,newspapers),pleaseprovidethenumberandnamesofthosesources:__________________________________________

o Totalnumberofsites,clinics,and/orpracticesthathaveenrolledatleast1participant:___________

o Namesofsites,clinics,and/orpracticesthathaveenrolledatleast1participant:______

Pleasedescribethefollowing:

1. Describeyoursystematicefforttoidentifypotentiallyeligibleindividualstoenrollinyourproject(i.e.,howareyoufindingpotentiallyeligibleindividualsforyourproject?).

a. Describeanysignificantchangesfromyourapprovedresearchplan.

2. Describeyoursystematicefforttoscreenindividualswhoappeareligible.RefertoMethodologyStandard,PC-2,anddescribehowthisstandardisbeingmet(i.e.,oftheindividualsidentified,howareyouapproachingand/ortestingthemtodeterminepotentialeligibility?).

a. Reportreasonsforineligibilityandthenumberofindividualsforeachreason.

3. Describeyoursystematicefforttodocumentinformationabouteligibleindividualswhodeclinetoenrollintheproject.

a. Reportreasonsfordecliningandthenumberofindividualsforeachreason.

4. Describeyoursystematicefforttoreduceattritionofparticipantsenrolledinyourproject(asapplicable).


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5. Reportthetimepointsatwhichparticipantsarelosttofollow-up(e.g.,mid-waythroughthe

intervention,aftertheintervention,specificfollow-uptimepoints)andthenumberofparticipantsforeachtimepoint.

CompleteTable2bylistingtheRacial/EthnicandGenderbreakdownoftheparticipantsenrolledinyourstudytodate.Ensuretotalsarecalculatedandappropriatelyrecorded.Ifyouhavenotcollectedthesedata,pleaseexplainwhy.AddaseparatetableforeachtypeofparticipantrecordedinTable1above.

Table2Racial/EthnicandGenderEnrollmentTable*

Race Male(N) Female(N) Total(N)

AmericanIndian/AlaskaNative

Asian

Black/AfricanAmerican

Hawaiian/PacificIslander

White

Multi-race

Other

Ethnicity Male(N) Female(N) Total(N)

Hispanic(Latino/Latina)

Non-Hispanic

*Ifmoredetailedinformationisavailableregardingracial/ethnicsubgroupsfortheparticipantsinyourstudy,pleaseshareaseparatetablewiththisinformationintheAdditionalDocumentssection.


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ACCOMPLISHMENTS AND CHALLENGES Discussanddocumentstudyprogressandallsignificanteventsforthecurrentreportingperiod.Inparticular,pleasediscuss: • Anysignificantchangefromthefundedapplication,includingchangesinthestudyprotocol,

engagementplan,endpoints,samplesize,etc.Includereasonsforthesechanges.PleasenotethatyoushoulddiscusschangeswithPCORIprogramstaffpriortoimplementationandsomechangerequirepriorapprovalfromPCORI(seeyourexecutedfundingcontractforchangesthatrequirePCORIpriorapprovalandnoticethirty(30)daysinadvanceoftheproposedchange).

Nosignificantchange.

• Progressandaccomplishmentsachievedduringthecurrent6-monthreportingperiod,with

referencetoplannedprojectactivities,milestones,andplanningfordissemination.(Pleaseincludethespecificmilestonelabelasrelevant.)

SubmittedmanuscripttotheBiometricson6/1/2016.GaveASAwebinaron5/24/16.GaveshortcourseatJohnsHopkinson6/22/16attheUniversityofWashingtonon7/26/16..GavetalkatBrownUniversityon4/4/16.AfoundationalmanuscriptdescribinghowtoanalyzerandomizedtrialswithdeathandintermittentmissingdatahasbeenacceptedatBiometrics.AnRpackagecalledidemhasbeenpostedonCRAN.AtranslationalversionofthisworkhasbeensubmittedtotheBritishMedicalJournal.

• Challengeswithprojectprogressincludinganticipatedupcomingchallenges(e.g.,delaysinIRB

approval,delaysinrecruitmentofsites,participantretentionissues).Howhaveyouovercomethesechallenges?Whatisyourcontinuedplanforovercomingthesechallenges?(Pleaseincludethespecificmilestonelabelasrelevant.)

ThesoftwaredevelopmentaspectofthisprojectisfundedbytheFDA.Wehavebeenbattlingtechnicalissuesregardingconstructingconfidenceintervalswithpropercoverage.Inpart,thisisduetosensitivityofourmethodstooutliers.Wehavenotyetfoundawayto“robustify”ourprocedures.Rightnow,ourbestrecommendationistoidentifyoutliersandremovethemfromtheanalysis.Afterremoval,ourproceduresworkwell.Withinthenextmonth,weplantoreleasesoftwarethatextendsSAMON(oursoftwareformonotonemissingdata)tohandlenon-monotonemissingdata.Themanuscriptsplannedunderthiscontractareofamoreappliednature;theycannotbesubmitteduntilthemorefoundationalarticleshavebeenaccepted.Rightnow,thefoundationalarticleunderlyingSAMONisunderreviewatBiometrics.ThemoreappliedPCOR-focusedversionofSAMONhasbeendraftedandwillbesubmittedoncethefoundationalarticlehasbeenaccepted.Thesameissueappliestothenon-monotonemissingdatamanuscript.WeexpectthatMilestoneD-4willbecompletedby10/31/16,MilestonesH1willbecompletedby9/30/16and


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wewillhavesoftwarefornon-monotonemissingdataby8/31/16.

• Asummaryofanyreportssubmittedtothesponsor,aDSMB,anIRB,theFDA,orotherregulatoryoroversightbodyaboutunanticipatedproblemsinvolvingriskstosubjectsorothersrelatingtotheresearchproject(e.g.,adverseevents,deviationfromapprovedprotocolthatplacessubjectsatincreasedriskofharm,databreach,proceduralormedicationerror)thatwerereportedduringthereportingperiod.N/A

• Asummaryofanysignificantdecisions,findings,recommendations,actionsanddirectionsofaDSMB,anIRB,theFDAoranyotherregulatoryoroversightbodyrelatingtotheresearchprojectduringthereportingperiod.N/A

• PleasereporthowyourprojectmeetsPCORI’sMethodologyStandardsthatapplytoyourongoing

research(enterN/Aifappropriate).ThefollowingStandardsshouldbeaddressedattheappropriatestudyphases(seetablebelow):

Methodology Standards to address Report how these Methodology Standards are being met

Upon Study Protocol Completion Data Integrity and Rigorous Analysis (IR-1, IR-

2 IR-3, IR-4)

N/A

Missing Data (MD-1, MD-2, MD-3, MD-4) N/A Heterogeneity of Treatment Effects (HT-1,

HT-2)

N/A

Causal Inference, if applicable (CI-1-6)

N/A

Data Registries, if applicable (DR-1-3) N/A

During Each Interim Progress Report Data Integrity and Rigorous Analysis (IR-1,

IR-2 IR-3, IR-4)

N/A

Adaptive Trials, if applicable (AT-1-5)

N/A

Missing Data (MD-1, MD-2, MD-3, MD-4) N/A


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ENGAGEMENT REPORT

Theend-usersofourmethodsandsoftwareare:(1)thosewhouseourtechnologytoanalyzeandreporttheresultsofclinicaltrialsand(2)thosewhoreviewtheresultsofclinicaltrialstomakedecisionsabouttreatments.

• Describeprogressonyourapprovedengagementplanduringthecurrent6-monthreportingperiod,

relativetotheactivitiesoutlinedinyourapplication.RefertoMethodologyStandardPC-1anddescribehowthisstandardisbeingmet.

Inthelastsixmonths,wehavebeendisseminatingourmethodsandsoftwaretoresearchers,practitionersandpolicymakers.WehavegivenshortcoursesattheJohnsHopkinsUniversityandUniversityofWashington.

• Describechallengeswithpatientandstakeholderengagement.Howhaveyouovercomethese

challenges?Whatisyourcontinuedplanforaddressingthesechallenges?

Thekeychallengeisaccesstoillustrativedatasetsandgettingstakeholderstouseourmethodsandsoftware.AkeystakeholderistheFDA.Wespeakwiththemmonthly.Thissummertheyhiredaninterntotestoursoftware.AswehaveindicatedtoourPCORIprojectofficers,wewouldwelcometheopportunitytoimplementthemethodsandsoftwareonPCORIsponsoredtrials.

• Forthe6-monthtimeintervals(i.e.,6months,18months,30months,etc.butnotat12monthsor24months),providespecificexamplesoftheimpactofengagementonprojectactivitiesduringthereportingperiod.Includeexamplesofallrelevantstakeholdersineachphaseofresearch–planningthestudy,conductingthestudy,anddisseminationwhereapplicable–perthePCORIEngagementRubric.

• Foreachannualreport(i.e.,atyear1,year2,etc.butnotat6monthsor18months),additional

descriptiveinformationonengagementofpatientsand/orotherstakeholdersshouldbereportedbelow.Thisreportisintendedtocapturetheperspectiveoftheresearchteam.Patientandstakeholderpartnerswillhaveadditionalopportunitiestoprovideinput.

Usethelinkbelowtocompletethisreport.YourUsernameisyourPCORIcontractnumber(noletters,dashes,orspaces).Provideyourengagementreporthere:https://live.datstathost.com/PCORI-Collector/Survey.ashx?Name=Engagement_Report_LoginWhenyouhavecompletedthequestions,recordyourconfirmationcode:N/A

PrincipalInvestigator(Scharfstein,Daniel,Scharfstein)

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FINANCIAL STATUS UPDATE

Describeanysignificantdeviationsincostsandbudget,howthosedeviationsaffectedthestudyprogress(e.g.,staffingandcostestimates),andanyanticipatedneedforbudgetmodifications.Significantdeviationsareconsideredanyadjustmentthatexceeds25%ofabudgetcategory. Therehavenotbeenanysignificantdeviationsincostsandbudget.


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KEY PERSONNEL EFFORT UPDATE

KeyPersonnelchangesmustbereported(seeyourexecutedfundingcontractforchangesinkeypersonnelthatrequirepriorPCORIapprovaloradvancewrittennotification).Reporttheindividual’srole,changeinpercentageeffort,andanexplanationforchanges.Ifyouhavemorethanfivechangestoreport,pleaseincludeadditionalinformationunder“ExplanationofChanges.”[email protected].

�Nochangesinkeypersonnel

Name(First,Last) Title ContractedPercentageEffort

ActualPercentageEffort

% % % % % % % % % %

ExplanationofChanges: Noteanyproposedchangestokeypersonnelinthenext6months,ifapplicable,andprovideanexplanationforchanges,below.Addrowsasnecessary.Ifyouhavemorethanfiveproposedchangestoreport,pleaseincludeadditionalinformationunder“ExplanationofChanges.”[email protected].

�Nochangesinkeypersonnel

Name(First,Last) Title ContractedPercentageEffort

ActualPercentageEffort

% % % % % % % % % %

Explanationofchanges:


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PUBLICATIONS UPDATE

REMINDER:Pleasemakesurethatallpublications/communication/mediapiecescontainthefollowingacknowledgementofPCORIfundingandrequireddisclaimer:

“Researchreportedinthis[work,publication,article,report,presentation,etc.]was[partially]fundedthroughaPatient-CenteredOutcomesResearchInstitute(PCORI)Award(##-###-####).”

“The[views,statements,opinions]inthis[work,publication,article,report]aresolelytheresponsibilityoftheauthorsanddonotnecessarilyrepresenttheviewsofthePatient-CenteredOutcomesResearchInstitute(PCORI),itsBoardofGovernorsorMethodologyCommittee.”

Inthetablesbelow,recordinformationregardingpublicationsandpresentations(scientificandnon-scientific)relatedtoyourPCORI-fundedresearchthatoccurredasofthereportingdate.Retaininformationsubmittedinpreviousreports.Publicationsand/orpresentationsbyanymemberoftheresearchteam,includingpatientandstakeholderpartners,shouldincludethose:

• Inpreparationtobesubmitted.• Thathavebeensubmittedtoapublication.• Thathavebeenacceptedtoapublication.• Thatarein-press.• Thathavebeenpublished.

Pleasesendanysubmittedorpublishedmanuscripts,otherpublications,andconferenceabstracts,asdescribedintheAdditionalDocumentssection.Pleasereviewthepublicabstractpostedonyourproject’ssummarypageonPCORI’swebsitehereandconfirmthatitisaccurateornotewhetherchangesareneeded.Ifchangesareneeded,pleaseattachyourupdatedabstracttoyourprogressreportsubmission(usetrackedchanges).


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ScientificManuscripts Title Type Status Journal* URL,ifapplicable

OntheAnalysisofTuberculosisStudieswith

IntermittentMissingData

Methods Published AnnalsofApplied

Statistics

InferenceinRandomizedTrialswithDeathand

Missingness

Methods Accepted Biometrics

GlobalSensitivityAnalysisforRepeatedMeasures

StudieswithInformativeDrop-out:ASemi-

ParametricApproach

Methods UnderReview Biometrics

GlobalSensitivityAnalysisofClinicalTrialswith

MissingPatientReportedOutcomes

Methods InPreparation ClinicalTrials

AccountingforMortalityandMissingDataWhen

ComparingClinicalOutcomesAcrossTreatment

GroupsinRandomizedTrials

Methods UnderReview BritishMedical

Journal

*targetjournalforpapersinpreparationScientificManuscripts,con’t:

Pleaseprovidethisadditionalinformationforacceptedorpublishedmanuscripts.ForACCEPTEDorPUBLISHEDmanuscripts

Title Authors**

Publicationdate

Volume(issue)

Page#s PMID

InferenceinRandomizedTrialswith

DeathandMissingness

Wang,Chenguang;Scharfstein,Daniel;

Colantuoni,Elizabeth;Girard,Timothy;

Yan,Ying

OntheAnalysisofTuberculosisStudies

withIntermittentMissingData

Scharfstein,Daniel;Rotnitzky,Andrea;

Abraham,Maria;McDermott,Aidan;

Chaisson,Richard;Geiter,Lawrence

12/2015 9 2215-

2236

**Includeallauthors,usingformat:Lastname1,Firstname1;Lastname2,firstname2;etc.


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OtherPublications(e.g.,bookchapter,report,organizationaljournals,newsletters,blogs,otherlaypress)Title PublicationType Status Nameof

publicationAuthors**

Publicationdate URL,ifapplicable

SurvivalAnalysis BookChapter UnderReview

Handbookof

Statistical

Methodsfor

Randomized,

ControlledTrials

Scharfstein,

Daniel;Zhu,

Yuxin;Tsiatis,

Anastasios

ProspectiveEHR-

BasedClinical

Trials:The

Challengeof

MissingData

Editorial Published Journalof

GeneralInternal

Medicine

Kharazzi,Hadi;

Wang,

Chenguang;

Scharfstein,

Daniel

4/16/2014

**Includeallauthors,usingformat:Lastname1,Firstname1;Lastname2,firstname2;etc.


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Peer-ReviewedPresentationsTitle Status Presentation

DatePresenter(s)

Name*Presenter(s)roleintheproject(Selectallthatapply)

ConferenceorMeeting

Name

MeetingLocation(City,State)

URL,ifapplicable

IntendedAudience(Selectallthatapply)

*Last,First Otherpresentations(e.g.,invitedtalk,localprovidermeeting,webinar,YouTubevideo)

Title PresentationType

PresentationDate

Presenter(s)Name*

Presenter(s)roleintheproject

(Selectallthatapply)

ConferenceorMeetingName,ifapplicable

PresentationLocation

**

URL,ifapplicable

IntendedAudience(Selectallthatapply)

GlobalSensitivity

Analysisof

Repeated

MeasuresStudies

withInformative

Dropout:ASemi-

Parametric

Approach

Oral 8/3/2014 McDermott,

Aidan

Researcher JointStatistical

Meetings,

Boston,MA Researchers

GlobalSensitivity

Analysisof

Repeated

MeasuresStudies

withInformative

Dropout:ASemi-

Parametric

Approach

Oral 9/18/2014 Scharfstein,

Daniel

Researcher AndreiYakovlev

Colloquium,

Universityof

Rochester

Rochester,

NY

Researchers

Inferencein

Randomized

TrialswithDeath

andMissingness

Oral 9/24/2014 Wang,

Chenguang

Researcher ASA

Biopharmaceuti

calSectionFDA-

Rockville,

MD

Researchers,

Practitioners


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Industry

Workshop

GlobalSensitivity

Analysisof

Randomized

Trialswith

MissingData:

RecentAdvances

Short

Course,

In-Person

12/8/2014 Scharfstein,

Daniel

Researcher Deming

Conference

Atlantic

City,NJ

Researchers,

Practitioners

Standardsinthe

Preventionand

Handlingof

MissingDatafor

Patient-Centered

Outcomes

Research

Oral 12/16/2014 Li,Tianjing Researcher JournalClub,

JohnsHopkins

Baltimore,

MD

Students

Analysisof

Randomized

Trialswith

MissingData

Short

Course,

In-Person

and

Adobe

Connect


Daniel;

McDermott,

Aidan;Wang,

Chenguang

Researchers JohnsHopkins

University

Baltimore,

MD

Researchers,

Practitioners

GlobalSensitivity

Analysisof

Randomized

Trialswith

MissingData

Poster 4/27/2015 Scharfstein,

Daniel

Researcher FDAORSI

Symposium

Rockville,

MD

Researchers,

Practitioners,

PolicyMakers

GlobalSensitivity

Analysisof

Randomized

Trialswith

MissingData

Short

Course,

In-Person


Daniel

Researcher Societyof

ClinicalTrials

Arlington,

VA

Researchers,

Practitioners


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Analysisof

Prospective

Studieswith

MissingData

On-Line

Lecture


Daniel;Li,

Tianjing


University

Baltimore,

MD

Researchers,

Practitioners,

PolicyMakers

GlobalSensitivity

Analysisof

Randomized

Trialswith

MissingData:A

Frequentist

Perspective


Daniel

Researcher FDA–Centerfor

Tobacco

Products

Rockville,

MD

Researchers,

Practitioners,

PolicyMakers

MissingDataand

Sensitivity

Analysesin

Randomized

Trials


Daniel

Researcher GlaxoSmithKline Valley

Forge,PA

Researchers,

Practitioners

GlobalSensitivity

Analysisof

Randomized

Trialswith

MissingData:

Fromthe

Software

Development

Trenches


Daniel

Researcher National

Instituteof

Statistical

Sciences

Washington,

Dc

Researchers

Analysisof

Randomized

Trialswith

MissingData

Short

Course,

In-Person

and

Adobe

Connect


Daniel;

McDermott,

Aidan;Wang,

Chenguang

Researchers FDA Rockville,

MD

Researchers,

Practitioners,

PolicyMakers

Inferencein

Randomized


Daniel

Researcher Brown

University

Providence,

RI

Researchers,

Practitioners.


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TrialswithDeath

andMissingness

Analysisof

Randomized

Trialswith

MissingData

Webinar 5/24/16 Scharfstein,

Daniel

Researcher American

Statistical

Association

Researchers,

Practitioners

Analysisof

Randomized

Trialswith

MissingData

Short

Course,

In-Person

and

Adobe

Connect


Daniel;

McDermott,

Aidan;Wang,

Chenguang


University

Baltimore,

MD

Researchers,

Practitioners

Analysisof

Randomized

Trialswith

MissingData

Short

Course,

In-Person


Daniel

Researcher Universityof

Washington

Seattle,WA Researchers,

Practitioners,

*Last,First**City,Stateoronline(e.g.,webinar)


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PROGRESS STATEMENT FOR PUBLIC USE Describenotableprogresstodate,preliminaryresults,(ifapplicable)andengagement/stakeholderexperiencesusingnontechnicallanguagethatisreadyforpublicuse.(Note:ThisinformationmaybepubliclydisseminatedbyPCORI.)Limit 250 words.

WepostedRandSASversionsofthesoftwareSAMONonthewww.missingdatamatters.orgwebsite.

ADDITIONAL DOCUMENTS All attachments should be combined with this document and submitted to PCORI as one PDF to

[email protected]. Anydocumentsthatyoufeelarerelevantandnoteworthycanbeshared,suchas:• Copiesofdraftsofinstruments,datadictionaries,educationalmaterials,manuals,orotherproject

deliverables,ifnotalreadydelivered• Abstractsfrompresentationsmadetoprofessionalgroupsorassociations• Manuscriptssubmittedorinpress• Summariesofpreliminarydata• Minutesorsummariesfrompatientand/orstakeholdermeetings• Bibliographies• SummariesfromDSMBmeetings• Finalstudyprotocol• Othercommunicationsefforts• Copiesofreportsfromanyconsultantsoradvisors,whereapplicable• Otherdocumentsormaterials,asappropriate• Websites,blogs,orotherInternet-basedlinks• Publicaffairsorpopularpresscoverageofthestudyonline,ontelevision,radio,etc.• NewandcontinuingIRBapprovals


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CERTIFICATION

This document must be certified by the Principal Investigator and the designated Administrative Official (AO). PrincipalInvestigator:�IcertifythatI,asthePrincipalInvestigator,havereviewedandapprovedthisdocument(andanyassociatedattachments,ifapplicable)andtheinformationprovidedinthisdocumentiscorrect.PIFirstName:DanielLastName:ScharfsteinDate:2/19/2015AdministrativeOfficial:�IcertifythatI,asthedesignatedAdministrativeOfficial,havereviewedandapprovedthisdocument(andanyassociatedattachments,ifapplicable)andtheinformationprovidedinthisdocumentiscorrect.AOFirstName: AOLastName: Date:

PCORI INTERIM PROGRESS REPORT - Biostatistics · Updated on Friday, February 12, 2016 PCORI INTERIM...

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Transcript of PCORI INTERIM PROGRESS REPORT - Biostatistics · Updated on Friday, February 12, 2016 PCORI INTERIM...