10 min

Gudrun Zahlmann
Neumarkt, Germany

Introduction: the EIBALL and QMIC initiative

20 min

Laure S. Fournier
Paris, France

Hypothesis generation: including primary/secondary endpoints and ground truth inclusion, exclusion criteria

1. To learn about introducing quantitative imaging endpoints in clinical research studies.
2. To appreciate the relationship between measured biomarkers, ground truth and clinical endpoints.
3. To understand the principle of reliable quantitative imaging biomarkers (QIBs) and their relation to clinical endpoints.

20 min

Gudrun Zahlmann
Neumarkt, Germany

Making the measurement: including precision, reproducibility, and validation

1. To learn about the use of metrology concepts in quantitative imaging.
2. To appreciate terms like precision, accuracy, bias, reliability and reproducibility in quantitative imaging measurements.
3. To understand the necessity of standardised imaging procedures for measuring QIBs.

20 min

Daniel Bos
Rotterdam, Netherlands

Statistical considerations: including study type, main tesoutcome measurements, biases

1. To learn about appropriate statistical concepts for the use of QIBs in clinical research studies.
2. To appreciate the accuracy and bias of QIBs and their statistical representation.
3. To understand the selection of useful statistical hypotheses and tests for one or multiple biomarkers based on clinical study outcome assessment.

20 min

Michael Vinzenz Knopp
Cincinnati, Ohio, United States

Practical issues: including ethics and leg funding, and planning

1. To learn how to plan, manage and analyse QIB-based clinical research studies.
2. To appreciate the organisational setup and requirements to provide reliable and reproducible results.
3. To understand the challenges of quantitative imaging biomarker studies and how to use them successfully.