pcori interim progress report - biostatistics · updated on friday, february 12, 2016 pcori interim...

PrincipalInvestigator(Scharfstein,Daniel,Oscar)

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: dscharf@jhu.edu

PIOfficePhone: 410-955-2420

AOFirstName: Ashley

AOLastName: Hoover

AOEmail: ahoover5@jhu.edu

AOOfficePhone: 443-997-1935

InstitutionLegalName: JohnsHopkinsUniversity

Address(street,city,

state,zipcode):

615NorthWolfeStreet

Baltimore,MD21205

Telephone: 410-955-3067

KeyPatientandOtherStakeholderPartnerContactInformation(uptothree):

Telephone/Email:

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

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

ColumnA ColumnB ColumnC ColumnD ColumnE ColumnF ColumnGMilestoneLabel

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

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.

ColumnA ColumnB ColumnC ColumnD ColumnE ColumnF ColumnGMilestoneLabel

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

Completed?(Yes/No)

DateCompleted

Clickheretoenteradate.

Yes No Clickheretoenteradate.

Chooseanitem.

Clickheretoenteradate.

Yes No Clickheretoenteradate.

Chooseanitem.

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

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

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).

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

Black/AfricanAmerican

Hawaiian/PacificIslander

Multi-race

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

Hispanic(Latino/Latina)

Non-Hispanic

*Ifmoredetailedinformationisavailableregardingracial/ethnicsubgroupsfortheparticipantsinyourstudy,pleaseshareaseparatetablewiththisinformationintheAdditionalDocumentssection.

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

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)

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

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

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)

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

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

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)

FINANCIAL STATUS UPDATE

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

KEY PERSONNEL EFFORT UPDATE

KeyPersonnelchangesmustbereported(seeyourexecutedfundingcontractforchangesinkeypersonnelthatrequirepriorPCORIapprovaloradvancewrittennotification).Reporttheindividual’srole,changeinpercentageeffort,andanexplanationforchanges.Ifyouhavemorethanfivechangestoreport,pleaseincludeadditionalinformationunder“ExplanationofChanges.”SendPCORIabiosketchforallnewkeypersonnelatfundedpfa@pcori.org.

�Nochangesinkeypersonnel

Name(First,Last) Title ContractedPercentageEffort

ActualPercentageEffort

% % % % % % % % % %

ExplanationofChanges: Noteanyproposedchangestokeypersonnelinthenext6months,ifapplicable,andprovideanexplanationforchanges,below.Addrowsasnecessary.Ifyouhavemorethanfiveproposedchangestoreport,pleaseincludeadditionalinformationunder“ExplanationofChanges.”SendPCORIabiosketchforallnewkeypersonnelatfundedpfa@pcori.org.

�Nochangesinkeypersonnel

Name(First,Last) Title ContractedPercentageEffort

ActualPercentageEffort

% % % % % % % % % %

Explanationofchanges:

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).

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-

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

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;

Chenguang;

Scharfstein,

Daniel

4/16/2014

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

Peer-ReviewedPresentationsTitle Status Presentation

DatePresenter(s)

Name*Presenter(s)roleintheproject(Selectallthatapply)

ConferenceorMeeting

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,

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,

Researchers

Inferencein

Randomized

TrialswithDeath

andMissingness

Oral 9/24/2014 Wang,

Chenguang

Researcher ASA

Biopharmaceuti

calSectionFDA-

Rockville,

Researchers,

Practitioners

Industry

Workshop

GlobalSensitivity

Analysisof

Randomized

Trialswith

MissingData:

RecentAdvances

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,

Students

Analysisof

Randomized

Trialswith

MissingData

Course,

In-Person

Connect

Daniel;

McDermott,

Aidan;Wang,

Chenguang

Researchers JohnsHopkins

University

Baltimore,

Researchers,

Practitioners

GlobalSensitivity

Analysisof

Randomized

Trialswith

MissingData

Poster 4/27/2015 Scharfstein,

Daniel

Researcher FDAORSI

Symposium

Rockville,

Researchers,

Practitioners,

PolicyMakers

GlobalSensitivity

Analysisof

Randomized

Trialswith

MissingData

Course,

In-Person

Daniel

Researcher Societyof

ClinicalTrials

Arlington,

Researchers,

Practitioners

Analysisof

Prospective

Studieswith

MissingData

On-Line

Lecture

Daniel;Li,

Tianjing

University

Baltimore,

Researchers,

Practitioners,

PolicyMakers

GlobalSensitivity

Analysisof

Randomized

Trialswith

MissingData:A

Frequentist

Perspective

Daniel

Researcher FDA–Centerfor

Tobacco

Products

Rockville,

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,

Researchers

Analysisof

Randomized

Trialswith

MissingData

Course,

In-Person

Connect

Daniel;

McDermott,

Aidan;Wang,

Chenguang

Researchers FDA Rockville,

Researchers,

Practitioners,

PolicyMakers

Inferencein

Randomized

Daniel

Researcher Brown

University

Providence,

Researchers,

Practitioners.

TrialswithDeath

andMissingness

Analysisof

Randomized

Trialswith

MissingData

Webinar 5/24/16 Scharfstein,

Daniel

Researcher American

Statistical

Association

Researchers,

Practitioners

Analysisof

Randomized

Trialswith

MissingData

Course,

In-Person

Connect

Daniel;

McDermott,

Aidan;Wang,

Chenguang

University

Baltimore,

Researchers,

Practitioners

Analysisof

Randomized

Trialswith

MissingData

Course,

In-Person

Daniel

Researcher Universityof

Washington

Seattle,WA Researchers,

Practitioners,

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

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

fundedpfa@pcori.org. 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

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:

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