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Therapeutic Area Standards: Reflections on Oncology Standards and What is Needed in the Future presented by Angelo Tinazzi @ CDISC Europe Interchange 2014]
This document discusses CDISC standards for oncology clinical trials and possibilities for the future. It addresses common questions around applying CDISC standards to oncology studies, noting different interpretations between sponsors. It summarizes how current CDISC standards fulfill oncology therapeutic area requirements through domains like TU/TR/RS for tumor response and QS-ECOG for performance status. The document also lists potential areas for clarification in the future, such as trial design elements like treatment schedules, cancer history, and exposure variables like treatment modifications. It raises questions about providing more guidance for non-solid tumor response assessments and additional terminology.
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Therapeutic Area Standards: Reflections on Oncology Standards and What is Needed in the Future presented by Angelo Tinazzi @ CDISC Europe Interchange 2014]
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- 2. © CDISC 2014 AngeloTinazzi, Cytel Inc, Geneva, Switzerland 2 Therapeutic Area Standards – Reflections on Oncology standards and what is needed in the future Geneva Branch
- 3. © CDISC 20143 Apply CDISC to Oncology Studies – Common Questions/Issues/Debates
- 4. © CDISC 2014 4 ApplyCDISC to Oncology Studies Two sponsors two interpretations Response to prior oncology therapies Sponsor A Sponsor B CMRELRECZR CMSUPPCM
- 5. © CDISC 20145 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
- 6. © CDISC 20146 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
- 7. © CDISC 201477 Questions