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portada RECIST 1.1 From Principles to Programming
Type
Physical Book
Publisher
Author
Year
2026
Language
English
Pages
386
Format
Paperback
ISBN13
9798903629046

RECIST 1.1 From Principles to Programming

Sunil Pilla (Author) · Notion Press Media Pvt. Ltd · Paperback

RECIST 1.1 From Principles to Programming - Sunil Pilla

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Synopsis "RECIST 1.1 From Principles to Programming"

What every oncology programmer needs. What no book has ever provided.RECIST 1.1 governs tumour response assessment in virtually every solid tumour oncology trial submitted to FDA, EMA, PMDA, and NMPA. Statistical programmers implementing it in SAS have always faced the same frustrating reality: the official guideline is written for radiologists, the CDISC standards describe data structures without clinical context, and the programming knowledge lives in senior colleagues' heads rather than on paper.RECIST 1.1 From Principles to Programming changes that. This 19-chapter reference covers the complete oncology programming workflow from first principles: clinical foundations, CDISC SDTM implementation, ADaM dataset construction, the estimand framework, time to definitive deterioration programming, and submission outputs.Every derivation is accompanied by complete, annotated, production-ready SAS macro code. Edge cases from real trial data - equivocal new lesions, missing assessments, lesion re-identification - are systematically addressed.Whether you are a statistical programmer onboarding to oncology, a biostatistician writing a RECIST-based SAP, a medical writer describing efficacy endpoints in a CSR, or a clinician who wants to understand how your patients' scans become the numbers in a regulatory submission, this is your reference. Read more

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