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Clinical Study Reports in Oncology

Level:
Advanced
Area:
Drug Development
Code:
DDA24a
Duration:
03:30:00
Workshop profile:
This workshop is intended for medical writers who have already some experience in the writing of clinical study reports (CSRs) but no experience in oncology. Participants should have a general understanding of clinical study designs, of the guidance provided by ICH E3, and should be familiar with statistics, in particular with time-to-event analysis.
Objective:
This workshop aims to provide a systematic overview of what is different about oncology CSRs. Having attended the workshop, Medical Writers should have an understanding of key oncology concepts and should be able to apply these to the writing of the different report sections.
Content:
The workshop will introduce key oncology concepts and will outline how these concepts inform the writing of the CSR. We will go through the report sections (following ICH E3). Topics discussed along the way will include: - Patients with cancer: diagnosis, treatment modalities, disease progression - Clinical studies in oncology: study design; interim vs. final analysis; trial committees (Data Monitoring Committee, Central Independent Review) - Drugs in oncology: principles of dose finding, treatment schedules, dose reduction / escalation, management of side effects - Efficacy: assessment of tumour response – RECIST; central independent review vs. investigator assessment of tumour imaging; time-dependent endpoints, especially progression-free survival, time to progression, overall survival; importance of censoring rules - Safety: CTCAE grading system, Dose Limiting Toxicities and Maximum Tolerated Dose, MedDRA and Standard MedDRA Query, the concept of "adverse events of special interest"