This document discusses CDISC standards for oncology clinical trials and opportunities for improvement. It notes that CDISC has incorporated domains for tumor response assessment but questions remain around implementing RECIST criteria and capturing prior cancer therapies. The document suggests areas where CDISC oncology standards could provide more guidance, such as trial design elements like unlimited treatment cycles, capturing exposure modifications, and providing more support for non-solid tumor response assessments. Overall, it examines current CDISC oncology standards and identifies examples of additional clarity and domains that could better meet the needs of oncology clinical research.

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2. 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

3. Apply CDISC to Oncology Studies –
Common Questions/Issues/Debates
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4. Apply CDISC to Oncology Studies
Two sponsors two interpretations
Response to prior oncology therapies
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Sponsor A Sponsor B
RELREC ZR CM
SUPPCM CM

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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6. 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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7. Questions
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