SubmissionGuidelines

ClinicalTrialResultsinvitesthesubmissionofphaseI,II,andIIIclinicaltrialsforpublicationinabriefprintformat,withfulltrialsresultsonline.Weencouragethesubmissionoftrialsthatprovidevaluableinsightintothepharmacology,druginteractions,andbiomarkercorrelatesofresponseforexperimentalagentsorexperimentalcombinations.Thisinformation,muchofwhichcurrentlyremainsunpublished,constitutesavaluablereservoirofclinicaltrialsinformation.ClinicalTrialResultsarepublishedinaunique,two-partformat:1. AbriefAuthorSummary,tobepublishedinprint.Thissummaryallowsthereadertoquicklygrasp

theaimanddesignofthestudy.Itismadeupofastructuredabstract(200wordsorless)containingfoursections:Background,Methods,Results,andConclusion;followedbyabriefDiscussion.ThisDiscussioncantakeoneoftwoforms:

• 350wordsandtwosalientgraphics,suchasatable,schema,waterfallplot,imageorgraph

• 450wordswithasinglesalientgraphic“LessonsLearned”highlightsthetrial'sessentialtake-awaymessages.

2. Thefulldataset,incorporatingallsupportingdocumentationandanextendedDiscussion,tobepublishedonline.Authorsareallowed1000wordsfortheextendedonlineDiscussion;theyareencouragedtobethorough,yetconcise.Thesponsor,coordinatingsite,participatingsites,andinvestigatorsshouldallbeclearlyidentified.

Thedatapublishedonlinetosupportthissummaryisthepropertyoftheauthors.TheAuthorSummaryandthefullClinicalTrialResultsshareatitleandDOI.

ReviewProcess

Onlywell-executedstudies,asattestedbypeerreview,areacceptedforpublication.Thesesubmissionsare rigorously reviewed by The Oncologist's internationally recognized editorial board, as well as byexternalrefereeswithrelevantexpertise.

The criteria used by reviewers to evaluate the potential value of the study include the number ofpatientsinthestudy,differencesortrendsseeninpatientsubsets,p-values,primaryoutcome(s)ofthestudy,andthequalityofthestatisticalanalyses.

TimefromSubmissiontoPublication

Because it is essential that the results of these studies be reviewed and publishedwith dispatch,weendeavortocompletepeerreviewwithin3weeksofmanuscriptreceipt.Acceptedpaperswillthenbepublished online ahead-of-print within 2 weeks. Hence, the expected gestation from manuscriptsubmissiontoonlinepublicationwillbeapproximately5weeks.

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InstructionsforSubmissionClinicalTrialResults.TheOncologist.com

TheClinicalTrialResultssubmissionsitehasbeendesignedforeaseofuse,tospeedthesubmissionandreviewprocess.

Somefieldsarerequired,butbecauseclinicaltrialsarediverseinnature,manyfieldsmaynotapplytoyoursubmissionsoarenotrequired.Therefore,pleasebealertasyoucompletethesubmissionprocessthatyoudonotoverlookanythingthatmightberelevantorimportant.

OverviewTab:

Usingacombinationofdrop-downmenusandfree-formtextfields,providethefollowinggeneralinformationaboutthetrial:

• TypeofStudy:PhaseI,II,orIII• Title• ClinicalTrials.govIdentifier• Sponsor• IRBapprovedclinicaltrial?(AlltrialsmustreceiveIRBapprovaltobeconsidered)• Manuscript:uploadtheassociatedmanuscriptfile

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YourInformationTab:

Completetherequiredfieldstoprovidecontactinformation,includingyouraffiliationandrelationshiptothetrial(e.g.,PrincipalInvestigator,CorrespondingAuthor).

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Co-AuthorInformation&OrderofAuthorsTab:

Provideyourco-authors’contactinformation,thenclickanddragontheirnamesunder“OrderofAuthors”tore-orderauthorsasneeded.

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AuthorSummaryTab:

ThebriefAuthorSummaryappearsinprint.Usethefree-formtextfieldsonScreen2toprovideastructuredabstract(Background,Methods,Results,Conclusions)of200wordsorless.Thefinalfield,Discussion,canbe350wordswith2associatedgraphics,or450wordswith1associatedgraphic.(Thegraphicsaregeneratedand/oruploadedlaterinthesubmissionprocess.)

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TrialInformationTab:

Usingthedrop-downmenusandfree-formtextfields,providebasicinformationaboutthetrial,includingthedisease(s)studied,stage,anypriortherapies,andprimaryandsecondaryendpoints.

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DrugInformationTab:

Usingthedrop-downmenusandfree-formtextfields,describethedrug(s)studied.Requiredfieldsaregeneric/workingnameanddrugclass.Itisrecommendedthatthedosingscheduleisprovidedaswell.

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PatientCharacteristicsTab:

Usingthetextfields,describethetrial’spatientcohort,includingthenumberenrolled,medianage,themediannumberofpriortherapies,ecogstatus,andcancertypeortypesstudied.

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PrimaryAssessmentMethodTab:

Usingacombinationofdrop-downmenusandfree-formtextfields,describetheprimaryassessmentmethod,and,ifapplicable,thesecondaryassessmentmethod.SecondaryassessmentmethodsincludePSAorCA125values,secondaryimagingmethods,orothernovelassessments.Requiredfieldsincludethenumberofpatients,theresponseassessment,andmediandurationassessments.Awaterfallplotcanbegeneratedbyselectingtheoptionandprovidingtherequireddataforeachpatient.ThewaterfallplotwillappearintheFigures/Tablesscreen,andyouwillbeabletoassignitthefigurenumberyouchoose.AKaplan-Meiergraphcanbegeneratedbyselectingtheoptionandprovidingtherequiredsurvivaldata.TheK-MgraphwillappearintheFigures/Tablesscreen,andyouwillbeabletoassignitthefigurenumberyouchoose.

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AdverseEventsTab:

Usingacombinationofdrop-downmenusandfree-formnumericfields,describeanyadverseeventsexperiencedbythecohort.Generally,adverseeventsoccurringin5%–10%ofenrolledpatientsshouldbeincluded.TheCTCAEversions3.0and4.0areavailabletoeasilydescribetheadverseeventsinastandardizedway.SelecttheappropriateversionoftheCTCAE,thenselectanadverseeventcategory,andthecorrespondingadverseevent.Inthegridthatappearsbelow,enterthenumberofpatientswhoexperiencedordidnotexperiencetheadverseevent,bygrade,andasummaryadverseeventtablewillbegenerated.Completingtheadverseeventdatainthiswayispreferabletoauthor-generatedadverseeventstablesinordertofacilitatesearchcapabilitiesandimproveddatasharing.Note:"AllGrades"shouldbeusedtoshowwhatpercentofpatientshaveadverseeventsdatareported.Therefore,thesumof%NC/NAandGrades1-5shouldbe100%unlessdataismissing.

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Pharmacokinetics&PharmacodynamicsTab:

Usingthefree-formtextfields,reportPK/PDinformation,includingCMAX,AUC,half-life,volumeofdistribution,andclearance.

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Assessment,Analysis&DiscussionTab:

Usingacombinationofpull-downmenusandfree-formtextfields,describethestatusofthetrialandprovideanassessmentoftheconclusions.IntheDiscussion,criticallyexaminethefindingsofthestudy,itsshortcomings,ifany,and,iftheresultswerenegative,explainwhytheymighthavebeenso.Inaddition,explorepossiblenextstepsregardinghowandwhy this studymaybeuseful topatientcareand further research.Use thisextendedonlinediscussion to answer this question: “If this could be done over again, would you use the same ordifferentdesign?”Ifthetrialdidnotcompleteplannedaccrual,acalculationofthestatisticalpoweroftheincompletetrialtoanswerthequestionposedshouldbeprovided.TheonlineDiscussionshouldbelimitedto1000words.Keyreferences,definedasthosethatareessentialforthereviewprocessorforreaderunderstanding,maybeincluded.ReferencesshouldbeinTheOncologistformatandinsertedintheDiscussiontextboxattheendoftheexpandedDiscussion.

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Figures&TablesTab:

Selectappropriatefiguresandtablestoaccompanythesubmissionbyclickingthe“choosefile”buttonandbrowsingtothefile’slocationonyourcomputer.Acceptableformatsinclude.eps,.tif,and.doc.Providealegendinthetextbox,thenclick“uploadfigure/table”.Repeattouploadasmanyfiguresand/ortablesnecessarytoproperlydocumentyourtrial.Asthefiguresareuploaded,thefilenameswillappearundertheheading“uploadedfigure/table.”Choosewhichgraphicyouwishtoappearinprintwiththeauthorsummarybyselectingit.Youmaydeleteunwantedfilesbycheckingtheboxnexttothefilename,thenselecting“deletechecked”fromthedrop-downmenu,thenclicking“apply”.Youmayreorderthefilesbyclickingonafilenameanddraggingittoitsdesiredlocationinthelist.Ifawaterfallplotwasselectedintheprimaryassessmentmethodsection,itwillappearhere.Likewise,AEtableswillappearhereifyouprovidedtherequireddataonscreen9.

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AuthorFormsTab:

FinalStep:SubmissionOverview

Reviewyoursubmissionforcompletenessandaccuracy.Click“SubmitResult”whenitisreadyforeditorialreview.