ESMO Handbook of Interpreting Oncological Study Publications

2018 ESMO Handbook of Interpreting Oncological Study Publications cover

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Watch the video presenting the Handbook by Veronika Ballová, co-editor of the ESMO Handbook of Interpreting Oncological Study Publications and member of the ESMO Publishing Working Group

In the past decade, the scientific world of oncology has changed considerably. An ever-increasing number of new interventions are being evaluated and study results are disseminated via an expanding number of peer-reviewed journals, congress presentations and other reports.

The ESMO Handbook of Interpreting Oncological Study Publications enables all of us to read between the lines of a scientific publication, to better estimate the true benefit of a new oncological intervention and to better understand other cancer-related research.

We take the clinician through studies that investigate the causes of cancer, its prognosis and treatment. Each chapter focuses on a specific type of study, its design and its value, providing examples to show how the studies are done and how their findings are reported. In this way, we can better find the balance between treatment need, treatment benefit and treatment hazard for our patients, and keep cancer care affordable.

Editors

Mike Clarke
Veronika Ballová
Henk van Halteren

Chapter 1 - Risk Factors

  • Why Should Oncologists Worry About Risk Factors?
  • Measurement of Risk
  • Causation
  • Conclusions
  • Further Reading
  • References

Chapter 2 - Screening

  • Introduction
  • The Benefit of Screening
  • The Harms of Screening: Overdiagnosis
  • Cost-effectiveness of Breast Cancer Screening Programmes
  • Conclusions
  • Further Reading
  • References

Chapter 3 - Prognosis

  • Introduction
  • Factors Influencing Cancer Survival
  • Improvement Over Time
  • Prognosis and Survival
  • Cancer Prognosis in Trials Versus Observational Studies
  • Types of Bias
  • Conclusions
  • References

Chapter 4 - Cancer Registries 

  • Introduction
  • Notification and Completeness of Cancer Registries
  • Minimal Data Set
  • Supplementary Items
  • Coding Rules
  • Follow-up
  • Epidemiological Studies with Cancer Registry Data
  • Quality of Care Studies with Cancer Registry Data
  • Conclusions
  • References 

Chapter 5 - Drug Development (Including Phase I Trials) 

  • Introduction
  • Strategies in Drug Development
  • Target Discovery Precedes Drug Discovery
  • Small Molecule Drug Discovery: Synthesis and Optimisation
  • Selection of a Drug: Preclinical Assays
  • Development of Anticancer Biologics
  • Towards Phase I Clinical Trials
  • Phase I Studies
  • Conclusions
  • Further Reading
  • References

Chapter 6 - Randomised Trials

  • Introduction
  • Using Systematic Reviews When Designing a Randomised Trial
  • Formulating the Question for a Randomised Trial
  • Eligibility Criteria
  • Outcome Selection
  • Sample Size
  • Randomising Patients
  • Blinding or Masking
  • Statistical Analysis
  • Reporting
  • Conclusions
  • Further Reading
  • References

Chapter 7 - Choice of Outcomes (Including Core Outcome Sets and Surrogate Outcomes)

  • Outcomes (or Endpoints)
  • Primary and Secondary Endpoints
  • Core Outcome Sets
  • Categories of Outcomes
  • Surrogate Endpoints
  • Endpoint Definition
  • Most Common Individual Outcomes Used in Oncology Clinical Trials
  • Conclusions
  • Further Reading
  • References

Chapter 8 - Statistical Issues (Including Subgroups, Time-To-Event Analyses, Multiplicity)

  • Introduction
  • Are the Data Adequately Described?
  • Which Quantities Have Been Estimated?
  • Which Statistical Tests Have Been Performed?
  • How is the Type-I Error Controlled?
  • Is the Statistical Power Adequate?
  • Subgroup Analyses
  • Conclusions
  • Further Reading
  • References

Chapter 9 - Systematic Reviews: A Key to Support Evidence-Informed Decision Making

  • Introduction
  • When is a Systematic Review Needed?
  • Formulating the Question
  • Defining Eligibility Criteria
  • Search Strategy
  • Study Selection
  • Assessing the Quality of the Studies and the Body of Evidence
  • Data Extraction from Studies
  • Synthesis
  • Conclusions
  • Further Reading and Resources
  • References

Chapter 10 - Clinical Research in Rare Cancers

  • Introduction
  • Challenges and Limitations in Clinical Research in Rare Cancers
  • Future Directions for Clinical Research in Rare Cancers
  • Conclusions
  • Further Reading
  • References

Chapter 11 - How to Become a Researcher

  • Introduction
  • Case Study 1: Marco
  • Case Study 2: Florence
  • Conclusions
  • Further Reading