MSc (Clinical Research)—full-time or part-time

EC584: Economic Evaluation in Health Care

Semester 1 | Credits: 10

The module examines the theory and practice of economic evaluation as it applies to health and social care interventions. Topics covered include the rationale for economic evaluation; formulating a health evaluation problem; identifying and measuring outcomes and effectiveness; identifying, enumerating, and valuing the inputs to form an economic measure of costs; measuring the benefits of health interventions using contingent valuation and discrete choice experiments
(Language of instruction: English)

Learning Outcomes

1. Understand the variety of economic evaluation techniques used to evaluate health interventions
2. Critically assess the different theoretical rationales for health interventions
3. Understand the different ways for measuring and valuing costs
4. Understand the various methods for measuring outcomes in cost effectiveness and cost utility analysis
5. Critically assess the advantages and disadvantages of QALYs
6. Understand the use of contingent valuation in health economics
7. Understand the use of experimental techniques to measure the value of interventions in health care
8. Conduct a literature search and review of CEA and CUA studies in a particular health intervention

Assessments

• Written Assessment (100%)

Teachers

•  CHARMAIN BYRNE 🖂
  
•  PATRICK GILLESPIE 🖂
  

Reading List

1. "Methods for the Economic Evaluation of Health Care Programmes" by Drummond, Michael F. et al.
   Publisher: Oxford University Press
2. "Applied Methods of Cost-effectiveness Analysis in Health Care" by Alastair Gray et al.
   Publisher: Oxford University Press
3. "Applied Methods of Cost-Benefit Analysis in Health Care" by McIntosh, Emma et al.
   Publisher: Oxford University Press
4. "The Elgar Companion to Health Economics" by Jones, Andrew M. et al.
   Publisher: Edmund Elgar

MD520: THESIS

12 months long | Credits: 30

Research will be performed in the participant’s own speciality with the aim of submitting a Thesis to University of Galway. Following University of Galway guidelines, the thesis will require 4 chapters with at least two chapters containing original research, with detailed review of methodological issues in all chapters.
(Language of instruction: English)

Learning Outcomes

1. Produce a substantial comprehensive literature review describing and critically assessing Clinical Research in a field of your interest
2. Demonstrate competence and professionalism in written communications.

Assessments

• Research (100%)

Teachers

•  AIDEEN O'DOHERTY 🖂
  
•  MARTIN JAMES O'DONNELL 🖂
  
•  SONJA KHAN 🖂
  
•  Andrew Smyth 🖂
  

MD1600: Bio-Ethics

Semester 1 | Credits: 10

This module will provide a comprehensive introduction to bio-ethics in the context of clinical research sciences. The module will instil the importance of balancing the need to advance our knowledge of medicine against the legal and ethical mandate to protect society.
(Language of instruction: English)

Learning Outcomes

1. Evaluate ethical issues from given scenarios and thus demonstrate a capacity to apply across a broad spectrum.
2. Evaluate the ethics relating to biobanking and current legislation around informed consent and ethical approval.
3. Consider the ethics of previous practice and hence demonstrate a capacity to review processes for the advancement of future endeavour.
4. Evaluate legislation practices and protocols, given consideration to all participants and, create a framework for disseminating learning to both peers and non-peers.

Assessments

• Continuous Assessment (80%)
• Department-based Assessment (20%)

Teachers

•  RÓISÍN DWYER 🖂
  
•  EVA ERZSEBET SZEGEZDI 🖂
  
•  EDEL MURPHY 🖂
  
•  SONJA KHAN 🖂
  
•  Andrew Smyth 🖂
  

MD1602: Introduction to the Ethical and Regulatory Frameworks of Clinical Research

Semester 1 | Credits: 10

This module is designed to provide an overview of core principles underpinning clinical research practice including the roles and responsibilities of members of the research team. Central to this module are the principles and practical application of Good Clinical Practice (GCP), relevant regulations and legislation, professional guidelines and codes of ethics including ethical dilemmas, vulnerable populations and research integrity.
(Language of instruction: English)

Learning Outcomes

1. Describe, understand and apply the principles of Good Clinical Practice when designing and undertaking clinical research projects.
2. Describe and explain the legal and regulatory issues in clinical research
3. Design, plan and execute research projects with appropriate research governance and operating within applicable ethical and legal frameworks including General Data Protection Regulation (GDPR).
4. Examine ethical issues in clinical research and select appropriate approaches strategies to navigate
5. Demonstrate an awareness of ethical practices and professional standards applicable to the field of clinical research

Assessments

• Continuous Assessment (30%)
• Department-based Assessment (70%)

Teachers

•  FRANCIS FINUCANE 🖂
  
•  SONJA KHAN 🖂
  
•  Andrew Smyth 🖂
  

MD511: Introduction to Biostatistics I

Semester 1 | Credits: 10

The module is designed to provide an introduction to the basics in Biostatistics, to enable students understand concepts of population distribution, sampling, probability, data type and presentation, statistical inference and hypothesis testing.
(Language of instruction: English)

Learning Outcomes

1. To demonstrate the importance and practical usefulness of statistics
2. To encourage and equip students to apply simple statistical techniques to design, analyse and interpret studies in a wide range of disciplines
3. To enable students to communicate the results of their analyses in clear non-technical language in writing up laboratory reports and projects
4. To make students aware of the limitations of simple techniques and encourage them to seek expert advice when more complex procedures are required
5. To utilise a statistical package on a computer to illustrate the power of statistical techniques and avoid tedious arithmetic
6. To provide examples of the uses of statistics in situations of relevance to students' other courses

Assessments

• Continuous Assessment (100%)

Teachers

•  JOHN NEWELL 🖂
  
•  AIDEEN O'DOHERTY 🖂
  
•  ALBERTO ALVAREZ-IGLESIAS 🖂
  
•  MARTIN JAMES O'DONNELL 🖂
  
•  SONJA KHAN 🖂
  
•  Andrew Smyth 🖂
  

Reading List

1. "Statistics for Sports and Exercise Science: A Practical Approach." by Newell, J., Aitchison, T. and Grant, S.
   Publisher: Pearson Education Limited.
2. "An Introduction to medical statistics" by Bland M.
   Publisher: UK Oxford University Press.
3. "Practical Statistics for Medical Research" by Douglas G. Altman
   Publisher: Chapman & Hall/CRC.
4. "Introduction to the practice of statistics" by Moore, D. S., McCabe, G. P., & Craig, B. A
   Publisher: New York: W.H. Freeman

MD510: Fundamentals of Health Research & Evaluation Methods

Semester 1 | Credits: 10

Provides a broad overview of clinical research methodology. Module is designed to provide an overview of research methodology, designs and content areas. Including: qualitative methodologies, concept of health, formulation of research questions, literature reviews, study designs, selection of study populations, choice of measuring instruments, and study interpretation issues such as determination of causality and the effectiveness of clinical and community interventions. This course is designed to introduce methodological issues to help students identify further learning objectives related to in‐depth study of specific research methods.
(Language of instruction: English)

Learning Outcomes

1. To examine quantitative research approaches, and appreciate their strengths and limitations
2. To learn how to apply these research approaches and methods by completing regular assignments and preparing a research protocol/paper in your own area of interest
3. Introduce methodological issues to help critically read scientific reports of health research
4. Grasp major components of research activities, including: study designs, selection of study populations, choice of measuring instruments, formulation of research questions, and study interpretation issues such as determination of causality and the effectiveness of clinical and community interventions.

Assessments

• Department-based Assessment (100%)

Teachers

•  AIDEEN O'DOHERTY 🖂
  
•  DIARMUID O'DONOVAN 🖂
  
•  DANIELLE NICHOLSON 🖂
  
•  MARTIN JAMES O'DONNELL 🖂
  
•  FRANCIS FINUCANE 🖂
  
•  SONJA KHAN 🖂
  
•  Andrew Smyth 🖂
  

Reading List

1. "Designing Clinical Research" by Stephen B Hulley
   ISBN: 9781608318049.
   Publisher: Lippincott Williams & Wilkins
2. "Users' guides to the medical literature" by editors, Gordon Guyatt ... [et al.].
   ISBN: 9780071790710.
   Publisher: ; McGraw-Hill Medical

MD1541: Harnessing the Basic Biology of Cancer for Development of Novel Therapeutics

Semester 1 | Credits: 10

This module will cover the molecular biology of cancer and how this knowledge drives development of treatment strategies. Learners will be introduced to key components of the translational paradigm, from laboratory-based experimentation to development of targeted therapies for cancer. The importance of Biobanks for clinical research will be highlighted, and the core aspects required discussed. The potential to use mesenchymal stem cells and their secreted vesicles for cancer therapy will be covered, along with advances in the field towards clinical application. [Please note CAR-T/immune cells are covered in MD1522 and will not form part of this module]
(Language of instruction: English)

Learning Outcomes

1. Describe key pathways involved in cancer development and progression, and the treatment strategies that target these specific pathways
2. Describe each stage of the Translational Paradigm, from target discovery through to changing standard of care
3. Define the key components of a clinically relevant Biobank, highlighting the ethical and infrastructural requirements
4. Describe the potential for clinical application of Mesenchymal Stem Cells as targeted Cancer therapeutics, and the challenges yet to be overcome
5. Demonstrate an understanding of the potential of Extracellular Vesicles for Cancer detection and Therapy

Assessments

• Continuous Assessment (100%)

Teachers

•  RÓISÍN DWYER 🖂
  

MD1603: Clinical Research Site Level Activities

Semester 1 | Credits: 10

(Language of instruction: English)

Learning Outcomes

1. Preparation of clinical trial protocol and other study associated documentation from a site level perspective
2. Describe the role and responsibilities of research team and staff involved in clinical trials
3. List clinical trials types, along with functions and processes during the life cycle of trials
4. Review the concepts of clinical trial activities from a site level perspective
5. Preparation of a clinical trial protocol and other study-associated documentation, from the site level perspective.
6. Comprehension of systems and interactions in the CRF environment from a site level point of view.

Assessments

• Department-based Assessment (100%)

Teachers

•  AOIFE LYONS 🖂
  
•  SONJA KHAN 🖂
  
•  Andrew Smyth 🖂
  

Reading List

1. "Clinical Trials" by Stuart J. Pocock
   ISBN: 1-118-79392-7.
   Publisher: John Wiley & Sons
2. "Pragmatic Randomized Clinical Trials" by Cynthia J. Girman,Cynthia J. Girman, DrPH, FISPE,Mary E. Ritchey, PhD, FISPE
   ISBN: 0128176636.
   Publisher: Elsevier
3. "Design, Execution, and Management of Medical Device Clinical Trials" by Salah M. Abdel-aleem
   ISBN: 0-470-47590-0.
   Publisher: John Wiley & Sons
4. "Clinical trials explained a guide to clinical trials in the NHS for healthcare professionals" by Derek Stewart
   ISBN: 1281322016.

MD519: Independent Study

Trimester 3 | Credits: 10

Research will be performed in the participant’s own speciality with the aim of writing a scholarly article suitable for submission to a relevant peer-reviewed journal for publication.
(Language of instruction: English)

Learning Outcomes

1. Reflect on what constitutes a research problem to be addressed in a scientific paper
2. Organise and compose a scientific paper in accordance with the guidelines outlined in Journal of interest
3. Analyse and review scientific papers in terms of key message, consistency and justification

Assessments

• Research (100%)

Teachers

•  AIDEEN O'DOHERTY 🖂
  
•  MARTIN JAMES O'DONNELL 🖂
  
•  SONJA KHAN 🖂
  
•  Andrew Smyth 🖂
  

EC572: Health Systems & Policy Analysis

Semester 2 | Credits: 10

This is a masters level module that examines the structure, conduct and performance of alternative models of finance and delivery in health care and critically examines the policy approaches developed to tackle key challenges in health and social care. The module builds upon the concept of market failure as it relates specifically to health care; critically appraises methods used to compare system performance and compares alternative systems in terms of performance. The objective of the module is to describe the key aspects of alternative health care systems; explore the evolution of a particular set of systems; examine how system structure relates to its operation and what light this sheds on the performance of those systems.
(Language of instruction: English)

Learning Outcomes

1. Understand the impact of market failure in health care on health and health care
2. Have a critical appreciation of the design, operation and evolutionary development of alternative models of health care delivery and finance
3. Be able to critically appraise alternative measures of health care system performance
4. Be able to critically appraise alternative models of health care system in terms of performance
5. Be able to critically appraise policy measures aimed at tackling key challenges for health care systems
6. Be able to source, gather, interpret and use health and economic data

Assessments

• Written Assessment (70%)
• Continuous Assessment (30%)

Teachers

•  CHARMAIN BYRNE 🖂
  
•  Sharon Walsh 🖂
  
•  Ronan Mahon 🖂
  

Reading List

1. "The Elgar companion to health economics" by Andrew Jones
   Publisher: Elgar Publishing
2. "Economic analysis in health care" by Morris S, Devlin N, Parkin D..
   Publisher: Wiley
3. "The economics of health and health care." by Folland S, Goodman AC, Stano M.
   Publisher: Pearson Education International
4. "Health Economics" by Phelps CE
   Publisher: Pearson Education International
5. "Health Economics: Fundamentals and flow of funds" by Getzen T.
   Publisher: Wiley
6. "The provision and use of health services, health inequalities and health and social gain" by Nolan B.
   Publisher: ESRI
7. "Health Policy Issues. An economic perspective on health reform" by Feldstein PJ.

MD513: Introduction to Biostatistics II

Semester 2 | Credits: 10

The module is designed to provide an introduction to statistical modelling techniques such as linear and non-linear regression, Analysis of Variance and Survival Analysis.
(Language of instruction: English)

Learning Outcomes

1. To provide a practical introduction to data analysis;
2. To encourage and equip students to apply simple statistical techniques to design, analyse and interpret studies in a wide range of disciplines
3. To make students aware of the limitations of simple techniques and encourage them to seek expert advice when more complex procedures are required
4. To utilise a statistical package on a computer to illustrate the power of statistical techniques and avoid tedious arithmetic

Assessments

• Continuous Assessment (100%)

Teachers

•  JOHN NEWELL 🖂
  
•  AIDEEN O'DOHERTY 🖂
  
•  ALBERTO ALVAREZ-IGLESIAS 🖂
  
•  MARTIN JAMES O'DONNELL 🖂
  
•  SONJA KHAN 🖂
  
•  Andrew Smyth 🖂
  

MD514: Introduction to Research Methods for Randomized Controlled Trials

Semester 2 | Credits: 10

This online/blended course utilizes interactive learning modules, required readings, discussion boards, tutorials and assignments to introduce students to the main elements of clinical trial design, execution and analysis. For aspiring clinical trial researchers, this is an essential introductory course which addresses the formulation of appropriate research questions and trial design for funding purposes.
(Language of instruction: English)

Learning Outcomes

1. Discuss core concepts of clinical trial design, execution, and analysis
2. firm grasp of clinical trial methodology at a level that would allow them to prepare detailed clinical trial protocols, suitable for submission to clinical research sponsors, funders, ethics boards and regulators
3. Explore principles that lead to developments of protocols for clinical trials

Assessments

• Continuous Assessment (100%)

Teachers

•  AIDEEN O'DOHERTY 🖂
  
•  MARTIN JAMES O'DONNELL 🖂
  
•  SONJA KHAN 🖂
  
•  Andrew Smyth 🖂
  

MD515: Systematic Review Methods

Semester 2 | Credits: 10

This online/blended course about research synthesis focuses on comparisons between alternative interventions. Interactive learning modules, required readings, discussion boards, tutorials, and assignments will be used to highlight rigorous systematic review methods, such as searching for potentially relevant articles, selecting primary studies using explicit, reproducible criteria, appraisal of study architecture, quantitative data synthesis and interpretation.
(Language of instruction: English)

Learning Outcomes

1. Critically discuss the role of systematic reviews within the context of evidence generation and evidence based health care
2. Identify the key stages of the systematic review process;
3. Develop a review question and understand how to develop a review protocol
4. Identify and develop appropriate search methods for identification of studies including the development of a comprehensive search strategy
5. Critically appraise the quality of included studies using methods appropriate to included study design types
6. Critically explore the principles of data synthesis and recognise the relevance of different methods of synthesis to different study designs
7. Explore methods for statistical (meta-analysis) and non-statistical synthesis of data/findings

Assessments

• Continuous Assessment (100%)

Teachers

•  AIDEEN O'DOHERTY 🖂
  
•  DECLAN DEVANE 🖂
  
•  EDEL MURPHY 🖂
  
•  MARTIN JAMES O'DONNELL 🖂
  
•  SONJA KHAN 🖂
  
•  Andrew Smyth 🖂
  

MD517: Clinical Research Administration

Semester 2 | Credits: 10

The successful operation and implementation of clinical research facilities and their services require efficient administration, on a number of levels. This module focuses on a variety of critical components from the administrative viewpoint and covers financial considerations, regulatory affairs, quality standards, data management, documentation, study monitoring and implementation, ethics and collaborations. The module is delivered using a blend of didactic lectures, problem-based learning in tutorial groups and project work performed by the student. This module can be taken by students interested in aspects of the establishment, management and control of CRFs and will contribute to a deeper understanding of the core structure of such facilities.
(Language of instruction: English)

Learning Outcomes

1. An understanding of the various elements involved in the establishment and operation of clinical research teams and associated clinical trials.
2. An appreciation of procedures involved in the successful completion and reporting of clinical trials.
3. Comprehension of quality systems and legal requirements in the research environment.
4. Preparation of a clinical trial protocol and other study-associated documentation, from the managerial perspective.
5. Appreciation for the development of data collection tools, in line with data protection regulations

Assessments

• Continuous Assessment (80%)
• Oral, Audio Visual or Practical Assessment (20%)

Teachers

•  AIDEEN O'DOHERTY 🖂
  
•  MARTIN JAMES O'DONNELL 🖂
  
•  SONJA KHAN 🖂
  
•  Andrew Smyth 🖂
  

Reading List

1. "Designing Clinical Research" by Stephen B Hulley
   ISBN: 9781608318049.
   Publisher: Lippincott Williams & Wilkins

MD518: Observational Studies & Analytical Research Methods

Semester 2 | Credits: 10

Review of observational research methods, including survey research, retrospective study, prospective cohort study, case-control design, scale development, diagnostic testing and qualitative research methods.
(Language of instruction: English)

Learning Outcomes

1. Introduce students to the basic concepts and methods used in observational (non-experimental) studies
2. To conduct needs assessments (e.g., prevalence of disease or order)
3. To understand the determinants of health (e.g., association between independent/exposure variables and dependent/outcome variables in analytic research)
4. To emphasise concepts that are essential to the conduct of epidemiologic studies including internal and external validity, random variability, bias, effect modification, causality, and generalisability.

Assessments

• Department-based Assessment (100%)

Teachers

•  AIDEEN O'DOHERTY 🖂
  
•  DANIELLE NICHOLSON 🖂
  
•  MARTIN JAMES O'DONNELL 🖂
  
•  SONJA KHAN 🖂
  
•  Andrew Smyth 🖂
  

MD1601: Biobank– Advanced Clinical Application and Clinical Testing

Semester 2 | Credits: 10

This module is designed to provide an overview of biobank processes, equipment, facilities and methodology for the purposes of clinical research. The module has been designed to provide learner with the capacity to critically evaluate the clinical environment, process and procedures in which specimens are obtained transported, stored, tested and analysed. Indicatively the module included: collection process, control protocol, storage and distribution, facilities and safety, quality management systems and data systems. This module introduces the students to a range of standardised Biobank clinical testing and outcome measures used in Clinical Research, the downstream analysis of biospecimen and how these influence correct administration, scoring and interpretation.
(Language of instruction: English)

Learning Outcomes

1. Evaluate of the requirements of a given test protocol and thus create a robust yet user-friendly SOP for clinical sampling, identification, transportation, storage and handling.
2. Provide a comprehensive review of process regarding specimen control and thus critically appraise relative to that that of emerging technologies and cutting edge national and international practice and report on findings.
3. Appraise current research in the area of biobank management, and report on the importance of functional operations such as specimen collection and handling.
4. Employ advanced clinical techniques and thus test, record, quantify and disseminate data for future analytical evaluation
5. Apply learning relating to clinical testing to advance new areas of clinical research in a particular field

Assessments

• Continuous Assessment (80%)
• Department-based Assessment (20%)

Teachers

•  NICOLA MILLER 🖂
  
•  SEAN HYNES 🖂
  
•  SHARON GLYNN 🖂
  
•  SONJA KHAN 🖂
  
•  Andrew Smyth 🖂