Presentation on theme: "UC5:Assigning of Epoch after treatment discontinuation (NS)"— Presentation transcript:
1 UC5:Assigning of Epoch after treatment discontinuation (NS) ScreeningTreatmentFollow upStudy epochs per protocol:Randomization,Treatment startEnd of treatment,Date of last trtEnd of study, consent withdraw
2 UC5: (cont.) subject information CRF pages: end of treatment, FU, end of studySubject has got 2 cycles. Last TRTDTC=Cycle 3 should start at , but subject has AE, thus treatment delay,No bettering after 14 days, Lab visit, EG Visit performed. => Physician decision to discontinue treatmentSubject comes to visit and decide not to go to FU, but to withdraw consent at , so no FU observation and data collection, end of study.Q: Which epoch and VISITNUM to assign to LB and EG visit in delay period?
3 QuestionOn which level should we handle treatment delay period: EPOCH or ELEMENT?
4 Definition from CDISC SDTM Epoch: As part of the design of a trial, the planned period of subjects' participation in the trial is divided into Epochs. Each Epoch is a period of time that serves a purpose in the trial as a whole. That purpose will be at the level of the primary objectives of the trial. Typically, the purpose of an Epoch will be to expose subjects to a treatment, or to prepare for such a treatment period (e.g., determine subject eligibility, wash out previous treatments) or to gather data on subjects after a treatment has ended.
5 Definition from CDISC SDTM Element: An Element is a basic building block in the trial design. It involves administering a planned intervention, which may be treatment or no treatment, during a period of time. Elements for which the planned intervention is "no treatment" would include Elements for screening, washout, and follow-up.
6 Definition from CDISC SDTM “If TAETORD and/or EPOCH are added, then the values must be those at the start of the visit”Chapter 5, “SV”, P35. Judgment will also have to be used in deciding how to represent a subject's experience if an Element does not proceed or end as planned. For instance, the plan might identify a trial Element which is to start with the first of a series of 5 daily doses and end after 1 week, when the subject transitions to the next treatment Element. If the subject actually started the next treatment Epoch [see Section 7 - Introduction: 7.1.2, Definitions Of Trial Design Concepts] after 4 weeks, the sponsor will have to decide whether to represent this as an abnormally long Element, or as a normal Element plus an unplanned non-treatment Element.Chapter 5, “SE”, P3
7 Handling on EPOCH level ScreeningTreatmentFollow upStudy epochs per protocol:Randomization,Treatment startEnd of treatment,Date of last trtEnd of study, consent withdraw
8 Epoch Level: Subject time axis No FU information collected in Original EDC DBLast treatmentConsent W.ScreeningTreatmentFollow up?LB and EG visitRandomizationTreatment startEnd of treatment,Date of last trtEnd of study, consent withdraw
9 How it looks in the data (Option 1) SEROWETCDSESTDTCSEENDTCSEUPDESEPOCH1SCRSCREENING2TRTTREATMENT3FUFOLLOW UP
10 How it looks in the data (cont.) ROWEPOCHVISITVISITNUMLBDTC1TREATMENTCycle 22FOLLOW UPCycle 33LBROWEPOCHVISITVISITNUMSVDYSVDTC1TREATMENTCycle 22FOLLOW-UPCycle 33???End of Treatment994End of Study999SVDate, where decision to stop treatment and study was made (last subject visit)ROWDSCATDSSCATDSDECODEEPOCHDSSTDTC1PROTOCOL MILESTONERANDOMIZATIONSCREENING2DISPOSITION EVENTEND OF TREATMENTAE???3END OF STUDYCONCENT WITHDRAWLFOLLOW-UPDSDate of last medication administration
11 Question to teamHow to populate EPOCH for „End of Treatment“ (SV obs 3, and DS obs 2) for that case:„FOLLOW UP“ in SV and DS (discrepancy with protocol schedule and SDTM IG as end of treament closed to treatment epoch)?„TREATMENT“ in SV and DS (discrepancy by date and sorting order for SV, discrepancy to SE)?„FOLLOW UP“ in SV and „TREATMENT“ in DS (agreement with SE based on date, but different EPOCH description for same event)?Leave blank?
12 Element level: Subject time axis No FU information collected in Original EDC DBLast treatmentConsent W.ScreeningTreatmentUnplanned SE, Treatment delay?LB and EG visitRandomizationTreatment startEnd of treatment,Date of last trtEnd of study, consent withdraw
13 How it looks in the data (Option 2) SEROWETCDSESTDTCSEENDTCSEUPDESEPOCH1SCRSCREENING2TRTTREATMENT3UNPLTreatment delay4FUFOLLOW UP
14 How it looks in the data (cont.) ROWEPOCHVISITVISITNUMLBDTC1TREATMENTCycle 22Cycle 33LBROWEPOCHVISITVISITNUMSVDYSVDTC1TREATMENTCycle 22Cycle 33End of Treatment994FOLLOW-UPEnd of Study999SVDate, where decision to stop treatment and study was made (last subject visit)ROWDSCATDSSCATDSDECODEEPOCHDSSTDTC1PROTOCOL MILESTONERANDOMIZATIONSCREENING2DISPOSITION EVENTEND OF TREATMENTAETREATMENT3END OF STUDYCONCENT WITHDRAWLFOLLOW-UPDSDate of last medication administration
15 Questions to teamCan we consider Treatment delay as Unplanned Element if it is acceptable according to ProtocolDo we need to define „FU“ Element /Epoch for this case in SE and other domains?
16 Questions to FDAIs variable EPOCH expected in SV and DS domains as well?Is discrepancy between scheduled visit number and EPOCH acceptable if described in RG? (considering option 1 as for other subjects Cycle 3 will correspond to „TREATMENT“ EPOCH)Would it be acceptable to have EPOCH blank with description in Reviewer Guide?