'Femi Fajimi

Medical Writing in Oncology: What Makes It Unique? 

By Femi Fajimi | 09 June 2025 

Oncology is one of the most complex and rapidly evolving areas in medicine, and medical writing in oncology reflects this complexity. Whether preparing a Clinical Study Report (CSR), protocol, or lay summary, oncology writing demands a deeper understanding of disease biology, trial design, and regulatory expectations. 

Working in regulatory writing has shown me just how distinct oncology is in terms of trial design, data interpretation, and communication style. 

Here are some key ways oncology medical writing differs from medical writing in other therapeutic areas; Insights that I’ve found vital: 

1. Complex Trial Designs 

Oncology studies often feature: 

• Adaptive trial designs (e.g. Phase I/II hybrid, basket or umbrella trials) 

• Stratified patient populations based on biomarkers or tumour genetics 

• Multiple endpoints assessed at different times (e.g. progression-free survival, tumour response) 

Writers must be comfortable interpreting and summarising these designs clearly for both technical and public audiences. 

2. Specialised Endpoints 

Unlike traditional trials that may focus on symptom resolution or lab markers, oncology uses endpoints such as: 

• Overall Survival (OS) 

• Progression-Free Survival (PFS) 

• Objective Response Rate (ORR) 

• Time to Progression (TTP) 

• Duration of Response (DoR) 

These endpoints require an understanding of how they are calculated, analysed, and interpreted, particularly relating to patient benefit and regulatory review. 

3. Regulatory Complexity 

Both EMA and FDA provide oncology-specific guidance documents, such as: 

• FDA: Clinical Trial Eligibility Criteria for Cancer Drug Development 

• EMA: Guidance on Oncology Drug Approvals and Risk-Benefit Evaluation 

Oncology drugs are also more likely to seek Accelerated Approval, Orphan Designation, or Breakthrough Therapy Status, all of which impact how and when writers support submission activities. 

4. Biomarker Integration 

Modern oncology trials are increasingly driven by genetic and molecular biomarkers, which influence: 

• Inclusion/exclusion criteria 

• Stratification 

• Efficacy interpretation 

Writers must accurately describe biomarker relevance and ensure clarity across protocols, Investigator’s Brochures (IBs), and CSRs. 

5. Emotional Tone in Patient-Facing Materials 

Cancer trials require exceptional sensitivity when drafting: 

• Informed Consent Forms (ICFs) 

• Lay Summaries 

• Recruitment materials 

Writers need to communicate risk and benefit with clarity, empathy, and honesty, avoiding false hope while remaining respectful. 

What Writers Should Know 

Area	Oncology-Specific Focus
CSR	Kaplan-Meier plots, adverse event interpretation, RECIST criteria
Protocol	Complex arms, crossovers, safety rules
ICF	High-risk interventions, progressive illness, detailed safety explanations
IB	Previous therapies, resistance profiles, mode of action
Lay Summary	Simple, sensitive language around survival, treatment impact

Final Thoughts 

Oncology medical writing is not just about data; it’s about context, ethics, and clear communication. Writers entering this field should stay curious, build familiarity with oncology endpoints, and seek examples across documents to see how science is communicated responsibly. 

As I explore this specialism further, I’ve found that writing in oncology challenges not just technical ability but also judgement, tone, and balance, all skills worth developing. 

References 

1. U.S. Food & Drug Administration (FDA). 
   Clinical Trial Eligibility for Cancer Drug Development: Guidance for Industry. 
   https://www.fda.gov/media/135078/download 

2. European Medicines Agency (EMA). 
   Guideline on the evaluation of anticancer medicinal products in man. 

3. ICH E9 (R1). 
   Statistical Principles for Clinical Trials. 
   https://www.ich.org/page/efficacy-guidelines 

4. RECIST Working Group. 
   New response evaluation criteria in solid tumours: Revised RECIST guideline (version 1.1). 
   Eur J Cancer. 2009 Jan;45(2):228-47. https://doi.org/10.1016/j.ejca.2008.10.026 

5. National Cancer Institute (NCI). 
   Cancer Clinical Trials – Understanding Trial Phases and Endpoints. 
   https://www.cancer.gov/about-cancer/treatment/clinical-trials/what-are-trials