therapeutic area standards: reflections on oncology standards and what is needed in the future...

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© CDISC 2014

Angelo Tinazzi, Cytel Inc, Geneva, Switzerland

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Therapeutic Area Standards –Reflections on Oncology standards and what is needed in the future 

Geneva Branch

© CDISC 2014 3

Apply CDISC to Oncology Studies – Common Questions/Issues/Debates

© CDISC 2014

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Apply CDISC to Oncology Studies Two sponsors two interpretationsResponse to prior oncology therapies

Sponsor A Sponsor B

CM

RE

LR

EC

ZR

CM

SU

PP

CM

© CDISC 2014 5

How CDISC currently fulfill Oncology TA requirements? SDTM IG 3.1.3 incorporates 3 new oncology (TU/TR/RS)

specific domains for efficacy tumour response assessment• Overcoming Difficulties in Implementing RECIST criteria, PhUSE 2013, G. Ruhnke• CDISC Journey on Solid Tumor Studies using RECIST 1.1., PhUSE 2013, K. Lee

SDTM QS-ECOG Eastern Cooperative Oncology Group Performance Status (ECOG)

Other oncology specific variables e.g. NCI-CTCAE Lab Criteria (LB.LBTOXGR)

SDTM IG 3.2 contains new domains that perfectly fit with Oncology TA requirements:

SS for Survival Status Update and DD for Death Details, PR for common oncology interventions e.g. surgery or radiotherapy, TD for protocol where disease assessment schedule do not match the “regular” study schedule e.g. tumor response, EC/EX for exposure data planned vs actual

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CDISC Onco TA in the future? Some Examples• More clarifications in Trial Design

Unlimited number of cycles Treatment Schedule vs Efficacy Assessment Schedule

Cancer History MH + SUPPMH + SC or ad hoc-domain

Prior and Follow-up Cancer Therapies In CM (CMCAT/CMSCAT) or ad-hoc domain

• Exposure Treatment modification

• Adverse Events Action Taken / Drug Relationship in drug combination trials

• Efficacy More guidance on non-solid tumor response assessment

• More Terminology

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Questions