Translating Imaging into Practice

IIDS67572 Translating Imaging into Practice 15 Semester 2 Postgraduate Taught Level 7 Marie-Claude Asselin Unit coordinator Division of Informatics, Imaging and Data Sciences 1 FHEQ level (Framework for Higher Education Qualifications) ' Masters/Integrated Masters P4 ' European Credit Transfer & Accumulation System Rating : 7.5 The unit will be lecture based, including lectures by mostly internal but also external imaging experts who will talk about the use of imaging biomarkers in a number of different disease areas and about some of the emerging imaging biomarkers and grand challenges for future biomarkers. It will draw examples from the widest variety of diseases, modalities and purposes.The unit will be divided into two sections. During the first 4-5 weeks (part A), the following will be covered:<ul><li>Formal definitions of biomarkers</li><li>Ways of classifying biomarkers depending on their nature and application<ul><li>ex-vivo bio-specimen versus in-vivo versus reported outcomes</li><li>prognostic, predictive, monitoring, and response biomarkers</li><li>pharmacokinetic, pharmacodynamic, and disease modifying</li><li>the pharmacologic audit trail (Workman)  </li></ul></li><li>Examples of imaging biomarkers in practice in medical research and healthcare and focused on their use in:  <ul><li>Neurology</li><li>Psychiatry</li><li>Oncology</li><li>Respiratory</li><li>Musculoskeletal</li><li>Cardiovascular</li></ul></li></ul>During part A, a project with be conducted (project A) where the skills gained from part A will be used to conduct a critical literature assessment of the classification of a selected imaging biomarker. This will be assessed through a mandatory formative oral presentation at the end of part A.During the remaining lectures (part B) the following will be addressed:<ul><li>Technical validation, qualification, surrogacy and QA/QC</li><li>How to technically validate an imaging biomarker, including: repeatability, reproducibility, accuracy and availability  </li><li>Evidence for biological validation</li><li>Regulatory, ethical and cost issues.</li><li>Emerging imaging biomarkers and grand challenges for future biomarkers</li></ul>During part B, a second project will be conducted (project B) where the skills gained from both part A and part B will be used to conduct a more in-depth critical literature assessment of the validation status of a different imaging biomarker. This will be assessed through a summative oral presentation at the end of the unit.A glossary of biomarker definitions can be found at: https://www.ncbi.nlm.nih.gov/books/NBK326791/  The unit will be lecture based, including lectures by mostly internal but also external imaging experts who will talk about the use of imaging biomarkers in a number of different disease areas and about some of the emerging imaging biomarkers and grand challenges for future biomarkers. It will draw examples from the widest variety of diseases, modalities and purposes.The unit will be divided into two sections. During the first 4-5 weeks (part A), the following will be covered:<ul><li>Formal definitions of biomarkers</li><li>Ways of classifying biomarkers depending on their nature and application<ul><li>ex-vivo bio-specimen versus in-vivo versus reported outcomes</li><li>prognostic, predictive, monitoring, and response biomarkers</li><li>pharmacokinetic, pharmacodynamic, and disease modifying the pharmacologic audit trail (Workman)  </li></ul></li><li>Examples of imaging biomarkers in practice in medical research and healthcare and focused on their use in:  <ul><li>Neurology</li><li>Psychiatry</li><li>Oncology</li><li>Respiratory</li><li>Musculoskeletal</li><li>Cardiovascular</li></ul></li></ul>During part A, a project with be conducted (project A) where the skills gained from part A will be used to conduct a critical literature assessment of the classification of a selected imaging biomarker. This will be assessed through a mandatory formative oral presentation at the end of part A.During the remaining lectures (part B) the following will be addressed:<ul><li>Technical validation, qualification, surrogacy and QA/QC</li><li>How to technically validate an imaging biomarker, including: repeatability, reproducibility, accuracy and availability  </li><li>Evidence for biological validation</li><li>Regulatory, ethical and cost issues.</li><li>Emerging imaging biomarkers and grand challenges for future biomarkers</li></ul>During part B, a second project will be conducted (project B) where the skills gained from both part A and part B will be used to conduct a more in-depth critical literature assessment of the validation status of a different imaging biomarker. This will be assessed through a summative oral presentation at the end of the unit.A glossary of biomarker definitions can be found at: https://www.ncbi.nlm.nih.gov/books/NBK326791/  To provide students with an understanding of:<ul><li>the diversity of imaging biomarkers (diseases, modalities, purposes, etc)  </li><li>the requirements of technical validation and qualification of imaging biomarkers and how this differs from molecular biomarkers</li><li>the differing needs of drug development, personalised healthcare, population studies, and clinical practice</li></ul>and an ability to:<ul><li>critically assess the qualification status of an imaging biomarker from published literature</li></ul>In addition, students will gain some awareness of:<ul><li>regulatory, ethical and cost issues</li><li>unmet needs and research opportunities </li></ul> A1 to D7 refer to ILOs in the programme specifications.  Students should be able to:1.1 Appraise the diversity of imaging biomarkers (diseases, modalities, purposes, etc.) (A4, A6)  1.2 Explain the requirements of technical validation and qualification (in particular how this differs with imaging biomarkers from molecular biomarkers) (A4, A7)1.3 Appraise the differing needs of applications in drug development, personalised healthcare, population studies, and clinical practice (A3)1.4 Explain the ethical, cost and regulatory framework requirements for imaging biomarkers (A5)1.5 Identify some of the most important unmet needs and research priorities. (A1)  Students should be able to:2.1 Analyse research proposals and interpret research results which use any type of imaging biomarker (B1)2.2 Classify imaging biomarkers from the published literature (B2)2.3 Evaluate the qualification status of an imaging biomarker from the published literature. (B7)  Students should be able to: 3.1 Identify the strengths and weaknesses of an imaging biomarker and appraise the evidence towards the qualification status for supporting its use. (C5)  Students should be able to: 4.1  Develop a conceptual framework for the design, conduct and evaluation of quantitative imaging studies for potential future employers such as drug companies, imaging companies, academic medical research and healthcare (D2, D7)4.2 Give an oral presentation on an imaging biomarker from reviewing the literature. (D1, D2)  The unit will consist of face-to-face lectures and group discussion with two project-based presentations (1 formative and 1 summative) to be attended by all students and consisting of classifying and reviewing the current validation status of an imaging biomarker from literature.  1 Written exam 60% 7 Oral assessment/presentation 40% <figure class="table"><table><thead><tr><th>Assessment</th><th>Length</th><th>Weighting</th></tr></thead><tbody><tr><td>Formative oral presentation on the classifications of a selected imaging biomarker (project A)ILO 2.1, 2.2, 4.2 </td><td>10 min</td><td>0%</td></tr><tr><td>Summative oral presentation on the validation status of a selected imaging biomarker (project B)IOLs 2.1, 2.3, 3.1, 4.2 </td><td>15 min</td><td>40%</td></tr><tr><td>Open book examILOs 1.1 to 1.5, 3.1, 4.1 </td><td>1.5 hours</td><td>60%</td></tr></tbody></table></figure> Formative presentation: Feedback provided within 1-2 hoursSummative assessments: Marks will be returned within 3 weeks. MSc Applied AI for Med Imaging MSc Applied AI for Med Imaging Not Set Mandatory N The material for this course comes from a variety of sources and is not available in a single reference text. However, some parts of the material are covered in the following:Books:BEST Resource <a href="https://www.ncbi.nlm.nih.gov/books/NBK326791" target="_blank">https://www.ncbi.nlm.nih.gov/books/NBK326791</a> Chapter Incorporating Predictive Imaging Biomarkers in Clinical Trials for Personalised Healthcare in Handbook of Biomarkers and Precision (2019) <a href="https://www.taylorfrancis.com/chapters/edit/10.1201/9780429202872-43/incorporating-predictive-imaging-biomarkers-clinical-trials-personalised-healthcare-john-waterton" target="_blank">https://www.taylorfrancis.com/chapters/edit/10.1201/9780429202872-43/incorporating-predictive-imaging-biomarkers-clinical-trials-personalised-healthcare-john-waterton</a> Further reading:Bradford-Hill criteria (1965) <a href="https://journals.sagepub.com/doi/10.1177/003591576505800503" target="_blank">https://journals.sagepub.com/doi/10.1177/003591576505800503</a>Imaging biomarkers roadmap for cancer studies (2017) <a href="https://www.nature.com/articles/nrclinonc.2016.162" target="_blank">https://www.nature.com/articles/nrclinonc.2016.162</a>  Lectures 12 Practical classes & workshops 30 Seminars 22 Tutorials 6 80