Postgraduate

MSc and Postgraduate Diploma in Clinical Trials

MSc Structure and Syllabus

Syllabus

Group CT1- Core Units

CT101 – Fundamentals of clinical trials [9160CT101]
This unit will provide students with a solid understanding of the main issues in the design and interpretation of clinical trials. The unit will outline the fundamental principles of comparative clinical trials in investigating effectiveness, efficacy and safety of treatments; and compare the benefits of clinical trials in comparison to alternative study designs. The main features of clinical trials, including methodological and organisational considerations, and the principles of trial conduct and reporting will be described. Key decisions surrounding design (including sample size), delivery and assessment of clinical trials will be explored.
Assessment: by one two-hour unseen written paper.

CT102 - Basic statistics for clinical trials [9160CT102]
This unit will introduce the basic statistical methods used in clinical trials. In particular, students will learn how to select and apply appropriate statistical methods to analyse data from clinical trials, presenting, interpreting and discussing the analyses clearly and concisely.  The unit will define probability and describe examples of its use. Normal, binomial and Poisson distributions and their application will be explored, and the principles of statistical inference, including point and interval estimation, and the role of sampling variation, will be explained. As part of this introduction, students will carry out basic data analyses from clinical trials using the computer-based Stata software package.
Assessment: by one two-hour unseen written paper.

CT103 - Clinical trials in practice [9160CT103]
The key steps in implementing a clinical trial are investigated in this unit, including clarifying and operationalising the primary and secondary objectives of clinical trials, the implications of design choices for implementation of a trial, trial governance, clearances (including research and ethical clearance), and data collection and recruitment methods.  The unit will explore quality assurance and control, and investigate data processing and management issues including post-trial monitoring.
Assessment: by one two-hour unseen written paper.

CT104 – Reporting and reviewing clinical trials [9160CT104]
This unit will cover both writing up completed trials, including guidelines for authors (such as the CONSORT Statements for reporting), and also guidelines for readers to aid their critical appraisal of trial reports. Ideally future policy, practice and further research  will be guided by the reports not merely of one trial but by the totality of the evidence.  A major component of the unit will therefore be the role of systematic reviews, including principles and procedures for conducting systematic reviews, problems and limitations; issues in the identification of randomised controlled trials; assessing trial quality; meta-analysis including cumulative meta-analysis; exploring heterogeneity; investigating for selection bias; and reporting of systematic reviews.
Assessment: by one two-hour unseen written paper and by written assignment(s).

Group CT2 –Advanced Units

Please note that unit CT201 is compulsory whereas units CT202-7 are optional.

CT201 – Protocol development [9160CT201]
Material in this compulsory unit will build on the work of the core study units, but will go further into the steps to be taken for preparing the protocol for a trial, including data collection forms, logistical and budgetary issues, and procedures of different funding bodies. By the end of this unit, students will have produced a protocol of sufficient standard to be developed into a submission for funding. 
Assessment: by one two-hour unseen written paper and by written assignment(s). Further information is given in the study materials for this unit.

CT202 – Trial designs [9160CT202]
By the end of this unit students should be able to appreciate the use of different trial designs such as non-inferiority and equivalence, cross-over, factorial, multi-armed and cluster randomised trials in assessing interventions and therapies, including complex interventions.  The strengths and weaknesses of each design will be discussed, together with their implications for sample size requirements, analytic methods, interpretation and reporting.
Assessment: by one two-hour unseen written paper and by written assignment(s).

CT203 – Project management and research co-ordination [9160CT203]
This unit will provide students with a full understanding of project and business management theory in the context of a clinical trial.  Students will learn how to develop a project management plan, identify key milestones and develop delivery plans. The unit will explore implementation and co-ordination of the project plan with an emphasiseon communication and project promotion and monitoring.  It will also consider the major challenge of identifying barriers to implementation and creating deliverable solutions.
Assessment: by one two-hour unseen written paper and by written assignment(s).

CT204 – Regulatory affairs,  good clinical practice and ethics [9160CT204]
The unit will cover the regulatory legislation and associated approvals and permissions required to conduct high-quality single-centre, national and international clinical trials. Integral to the legislation is Good Clinical Practice (GCP).  Students will gain a solid understanding of GCP and will explore ways of implementing GCP, including risk assessment and trial monitoring. A variety of clinical and geographical settings will be examined. Ethical issues will be considered throughout the unit.
Assessment: by one two-hour unseen written paper and by written assignment(s).

CT205 – Data management [9160CT205]
This unit covers issues in the collection of data and their subsequent management prior to analysis.  Students will define and write a management plan and use different computer packages to implement the plan in practice.
Assessment: by one two-hour unseen written paper and by written assignment(s).

CT206 – Data monitoring and interim analyses [9160CT206]
This unit will cover issues relating to the on-going monitoring of the data in a study in order that sufficient data are available to answer the trial’s question reliably without recruiting more patients than necessary, or exposing them to unnacceptable risks. The unit will therefore focus on the ethical context of decisions about whether or not to continue entering patients into trials.  A number of different statistical approaches will be explored, and the role and conduct of data monitoring committees in this process will be examined.
Assessment: by one two-hour unseen written paper and by written assignment(s).

CT207 – Design and analysis of epidemiological studies [9160CT207]
Epidemiological studies often provide important background information prior to initiating a trial. Additionally, trial datasets may prove to be the basis for further epidemiological research. In this unit students will be introduced to the key considerations in planning and designing epidemiological  studies.  This will include descriptions and interpretations of epidemiological measures, including disease frequency, effect, and public health impact, and the relative merits of different study designs.  Strategies for addressing sampling error, bias and confounding in epidemiological studies will be demonstrated.  Students will consider a range of analytic methods including stratified and multivariable approaches, and be able to critically appraise the design, analysis and interpretation of published epidemiological studies. Students studying this unit will be able to register for additional advanced epidemiology units.
Assessment: by one two-hour unseen written paper and by written assignment(s).

CT208 – Further statistical methods in clinical trials [9160CT208]
This unit will build on unit CT102 to cover more advanced statistical methods used in clinical trials.  Methods of analysis covered will include graphical data analysis, analysis of variance, linear regression, logistic regression and survival analysis.  Students will also cover topics such as adjustment for covariates, repeated measures and other correlated data, missing data, sub-group analyses and sensitivity analyses.  Data analyses will be carried out using Stata.
Assessment: by one two-hour unseen written paper and by written assignment(s).

CT209 – Cluster randomised trials [9160CT209]
Trials in which individuals are randomised in groups (clusters) are being increasingly utilised, especially in the fields of infectious diseases, implementation research, and public health and complex interventions.  This unit will consider the advantages and disadvantages of the use of cluster trials, with particular emphasis on statistical considerations for their design and analysis, as well as the implications for informed consent and reporting.
Assessment: by one two-hour unseen written paper and by written assignment(s).
Please note: except with the special permission of the Course Organiser students must study CT208 or EP304 before taking this unit.

Additional optional advanced units

Students may choose up to two of the following additional optional advanced units, subject to the following pre-requisites.

EP301 Epidemiology of communicable diseases [670E301]
This unit covers the factors that suggest a disease has an infectious cause, those determining the spatial, temporal and social distributions of communicable diseases, and the measurement of the transmissibility of infections.  By the end of the unit, students  should be able to design, carry out, analyse, interpret and report an outbreak investigation, understand the principles underlying mathematical models of communicable diseases, methods for the evaluation of vaccine efficacy, and practical applications of epidemiological methods through the study of specific diseases.
Assessment: by one two-hour unseen written paper and by written assignment(s). 
Please note: except with the special permission of the Course Organiser students must study CT207 before taking this unit.

EP303 Epidemiology of non-communicable diseases [670E303]
This unit will provide an overview of non-communicable diseases in both developed and developing country settings, the global burden of such diseases, temporal trends in mortality from cardiovascular diseases and cancer, diet and cancer and the epidemiology and prevention of mental disorders.  By the end of the unit, students will be able to develop and criticise strategies for prevention of cardiovascular disease at the community and individual level.
Assessment: by one two-hour unseen written paper and by written assignment(s).
Please note: except with the special permission of the Course Organiser students must study CT207 before taking this unit.

EP304 Advanced statistical methods in epidemiology [670E304]
This unit will cover regression methods for the analysis of case-control and cohort studies, using appropriate computer software. 
By the end of the unit the student should be able to plan a strategy of analysis for an epidemiological data-set, using an appropriate choice of methods, appreciate the effects of correlated data on epidemiological analysis, and the use of statistical methods which take account of such correlations, and interpret and criticise the statistical methodology presented in published epidemiological papers.
Assessment: by one two-hour unseen written paper and by written assignment(s).
Please note: except with the special permission of the Course Organiser students must study CT207 before taking this unit.

EP306 Human genetic epidemiology  [670E306]
[Note: students must have good internet access to study this module.]
By the end of this module students should be able to:
· demonstrate understanding of fundamental concepts of genetics
· understand papers which describe genetic epidemiological findings
· apply basic epidemiological principles to the critical interpretation of genetic epidemiological studies
· appreciate the study designs and the methods of statistical analysis used to evaluate the role of genetic inheritance in the occurrence of human disease, and to determine the location of the gene(s)/allele(s) responsible for a disease.
Assessment: one two-hour unseen written paper and written assignment(s).

EP305 Molecular and genetic epidemiology [670E305]
By the end of this unit students should be able to understand papers which describe molecular and genetic epidemiological findings and appreciate the roles of molecular techniques in furthering the understanding of the epidemiology of diseases.  The unit will include the application of basic epidemiological principles to the critical interpretation of molecular and genetic epidemiological studies.  Students will be able to demonstrate understanding of fundamental concepts of genetics, and to appreciate the study designs and the methods of statistical analysis used to evaluate the role of genetic inheritance in the occurrence of human disease, and to determine the location of the gene(s)/allele(s) responsible for a disease.
Assessment: by one two-hour unseen written paper and by written assignment(s)
Please note: except with the special permission of the Course Organiser students must study CT207 before taking this unit.

PH204 – Economic Evaluation [953P204]
This unit aims to allow students to understand and apply current methods in the economic evaluation of health interventions. Topics include: measurement; valuation and analysis of costs; techniques for measuring and valuing health outcomes; the presentation of cost and effect data; and critical appraisal of economic evaluation in health care decision making.
Assessment: by one two-hour unseen written paper and by written assignment(s)

PH207 - Health Care Evaluation [953P207]
This unit will consider how the principles of scientific evaluation can be applied to the dimensions of effectiveness, efficiency, humanity and equity. The unit will cover the quantitative (including both experimental and observational designs) and qualitative methods used in evaluation of these four dimensions. It will also consider the challenge of measuring key outcomes such as disease, health status and quality of life and address the issues involved in measuring costs.
Assessment: by one two-hour unseen written paper and by written assignment(s).

PH211 Medical anthropology in public health [953P211]
This module introduces concepts of social and medical anthropology, drawing attention to its application to public health. It introduces the history, theoretical frames and methods of social and cultural anthropology, and of the sub-discipline of medical anthropology. It then examines social and cultural perceptions of sickness, medical pluralism and health seeking behaviour, the anthropology of infectious diseases, of biomedicine and of medicines, and the relations between cultural constructions of the person, the body and sickness. Finally, it explores the potential of anthropology to study (and improve) public health interventions and medical research itself.
Assessment: one two-hour unseen written paper and written assignment(s).

Integrating unit [9160CT210]

This compulsory unit will integrate material from the MSc study units.
Assessment: by unseen written paper and by written assignment. Further information is given in the study materials for this unit.