Our iBSc Clinical Trials offers you a unique opportunity to learn the important concepts and practices underpinning appropriate clinical trial design, conduct, analysis, and interpretation of trials.
- The Institute of Clinical Trials and Methodology leads many UK and international trials which have, and continue to influence clinical practice.
- You will be taught by staff (clinical and non-clinical) who have expertise in infectious diseases, cancer and methodology, using real-life clinical trial examples to help consolidate your learning.
This course is open to MBBS students only.
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About the Course
Clinical trials are essential to help us discover whether new healthcare interventions improve outcomes for patients and the public. Our iBSc Clinical Trials offers you a unique opportunity to learn the important concepts and practices underpinning appropriate clinical trial design, conduct, analysis, and the interpretation and reporting of results.
The Institute of Clinical Trials and Methodology (ICTM) leads many UK and international trials which influence clinical practice. The ICTM has the largest group of trialists - approximately 400 - in Europe. The Institute is part of the Faculty of Population Health Sciences in the UCL School of Life and Medical Sciences.
In this one-year programme you will explore the role of the clinician in clinical trials. The programme will help shape your approach to clinical trials and the importance of clinical evidence for the rest of your MBBS programme and in your future career.
The first term of the programme is designed to provide you with a firm foundation in clinical trials from the research idea, through trial design, set up and conduct, to analysis and reporting of results. The need for clinical trials to improve upon standards of care will be clearly outlined during the first term. You will gain sufficient practical knowledge of statistics to enable you to critically evaluate the evidence base. You will later apply these skills when completing your research project.
In term two, you will be guided through real world examples of clinical trials to explore how the principles you have learned in term one apply to clinical trials in practice. You will learn about the purpose and conduct of systematic reviews and meta-analyses, and their application.
In terms two and three you will also undertake an independent research project which will enable you to carry out a literature review, perform an independent analysis of your findings and report your results in a dissertation.
Aims & Objectives of our iBSc Clinical Trials Programme
The aim of the programme is to teach you the:
- Important concepts and practices required to ensure appropriate clinical trial design, conduct, analysis, and interpretation and reporting of results
- Clinical perspectives on trials by applying clinical trial design principles into practice
- Roles and responsibilities of the clinical team, whilst exploring the logistics and challenges of trials nested within clinical practice
iBSc Clinical Trials Programme Structure
The course consists of five taught modules, one practical/log-based module and a research project.
You will be taught by staff (clinical and non-clinical) from ICTM who have expertise in specific disease areas, e.g. infectious diseases, neurodegenerative diseases and cancer as well as in clinical trial methodology. They will use real-life clinical trial examples to help consolidate your learning.
Teaching on each module will be delivered through a combination of lectures and tutorials. This will include the traditional face-to-face teaching and Lecturecast/audio recordings. There will be lots of opportunities for discussion and activity-based learning.. The majority of teaching will be carried out by ICTM staff, with external speakers invited for special theme sessions (as required). Private reading, self-study and revision will also be required. Moodle will be used to direct you to relevant publicly available websites/links and to other relevant online learning materials to support the learning. You will be encouraged to actively seek external sources related to the module content and discuss these in the classroom/online sessions. Assessments have been chosen to replicate real-world activities and / or to help you prepare you for writing up your project dissertation.
Face-to-face teaching will take place on the main UCL Bloomsbury campus. You will undertake hands on work with the trial teams at ICTM, 90 High Holborn.
Close of applications for UCL students was 4th January 2022, and for external students is 31st March 2022. The course sits within a portfolio of undergraduate courses offered by the Division of Medicine, click here for further information.
Term 1: Fundamentals of Clinical Trials (15 credits)
The module will outline clinical research and clinical trials, from history and the scope to introducing the phases, types and designs of trials to set the scene for learning. The module will address how trialists decide on the research questions to address, and provide an overview of risk assessment, protocols, patient information sheets, patient recruitment, informed consent, ethical approval, good clinical practice and trial oversight. The importance of patient and public involvement in clinical trials and good communication will be addressed throughout the module.
The following topics will be covered in the module:
- Clinical research and observational studies
- History of clinical trials
- Introduction to phases, types and designs of clinical trials
- Deciding on research questions to address in clinical trials
- Risk assessment, clinical trial protocols and patient information sheets
- Ethical approval, good clinical practice and trial oversight
- Introduction to patient recruitment and informed consent
- Introduction to patient and public involvement in clinical trials
- Clinical trial communications
Module assessment: Small group work and oral presentation with slides (15 minute presentation, 15 minutes for questions). You will identify a research question and justify the need for a trial to answer that question.
Term 1: Clinical Trials Design and Statistical Analysis (15 credits)
The module will outline trial design implications for a broad range of trial types across all phases, keeping you informed of innovations in trial design as appropriate. You will be guided to perform sample size calculations (including practical examples), choose appropriate outcome measures and decide on appropriate analyses (descriptive statistics, hypothesis testing, analysis of continuous, binary and time-to-event data, performance characteristics of clinical tests - sensitivity, specificity, positive predictive value, negative predictive value).
The following topics will be covered:
- Phases of clinical trials
- Trial design as applicable to Phase 1/2/3 (3+3 vs model-based designs; single-arm vs randomised designs; parallel, factorial, cross-over; seamless designs, innovative clinical trial design for precision medicine: umbrella, basket, adaptive study designs)
- Sample size calculations with practical examples
- Choosing appropriate outcome measures
- Analysis - descriptive statistics, hypothesis testing, analysis of continuous, binary and time-to-event data
- Performance characteristics of clinical tests: sensitivity, specificity, positive predictive value (PPV), negative predictive value (NPV)
Module assessment: Short answer questions on statistical concepts and their application.
Module 3: Clinical Perspectives in Trials (15 credits)
The module will outline how clinical research enhances standard of care and will delineate the roles and responsibilities of the clinical team in clinical research. The module will guide you to identify gaps in standards of care where trials might be undertaken. The role of the clinical team in the conduct of trials, from the clinical setting to oversight, will be explored with practical examples given throughout the module. The framework and ethical principles/requirements around informed consent and participating in trials will be taught, including Declaration of Helsinki, Data Protection, Good Clinical Practice and GDPR. The process and how participants are protected throughout the clinical trial journey will be explored from an ethical prism. The critical role of clinicians into capturing data regarding the trials they conduct/participate in which informs trial findings will be addressed. Case studies will be embedded throughout the module to aid knowledge synthesis.
The following topics will be covered:
- Introduction to clinical research to enhance standard of care
- Roles and responsibilities of the clinical team in clinical research
- Consent process and how to protect patients and study participants
- Clinician input into data and documents required in clinical trials/research
- Case studies will be embedded throughout the module to aid synthesis
Module assessment: Essay (2,500 words) on a topic covered during the module, giving you the opportunity to practise your skills in research and enquiry, scholarly practice and professional skills and show your knowledge and understanding of the topic, for example: Identify shortcomings in a current standard of care and suggest a clinical trial to address the problems.
Term 2: Systematic Reviews and Meta-Analysis (15 credits)
The module will introduce the concept of evidence synthesis in clinical research and why it is needed. The key aspects of the design and conduct of systematic reviews and meta-analysis, focussing on questions of clinical effectiveness (treatment comparisons), will be addressed. The module will focus on understanding, assessing and reducing bias in the context of systematic reviews and guide you to understand, interpret and appraise published reviews. The role of systematic reviews and meta-analysis in practice, and how they influence research, policy and practice will be embedded throughout the module.
The following topics will be covered:
- An introduction to the concept of evidence synthesis in clinical research and why it is needed
- Key aspects of the design and conduct of systematic reviews and meta-analysis - focussing on questions of clinical effectiveness (treatment comparisons)
- Understanding, assessing and reducing bias in the context of systematic reviews
- Understanding, interpreting and appraising published reviews
- Systematic reviews and meta-analysis in practice - how do they influence research, policy and practice?
Module assessment: You will be asked to complete an individual oral presentation to outline a question for a systematic review topic (10 minute presentation, 5 minutes for questions). You will need to demonstrate a clear rationale and research objectives, explain the key inclusion and exclusion criteria and define outcome measures for the review.
Term 2: Applying Clinical Trial Design Principles in Practice (15 credits)
This module will give you an in-depth applied knowledge and understanding of clinical trial design and analysis using a range of examples from current/past trials in a number of different disease areas and research settings.
Trials in the following areas will be covered:
Primary care, mental health, complex environments, cancer, infectious diseases, medical devices, advanced therapies, ophthalmology, paediatrics, neuroscience and international trials.
Module assessment: Essay (2,500 words) comparing trials which have successfully addressed a research question with those where the design/conduct could have been improved on (from the themes explored during the module).
Terms 1 and 2: Knowledge through Practice (15 credits - hands-on module)
This module will comprise a log-book based activity where you are set tasks to complete based on the hands-on experience you have gained. You will be invited to attend trial team and other Institute of Clinical Trials and Methodology meetings, seminars and events. You will also be invited to observe trial oversight committee meetings.
These are the key components you will need to report on:
- Trial design - from a practical perspective
- Being able to respond to challenges during trial conduct: attending to patient safety and data and trial integrity
- Critical analysis of the papers resulting from clinical trials - Journal Clubs
- Understanding the reporting of trials - web casts from conferences/public meetings (you will be asked to watch these and then present the summary results as group work)
- Clinical observations (clinics recruiting to trials) or visits to the NIHR UCLH Clinical Research Facility
Module assessment: Log-book completion based on Clinical Trials Unit activities (up to 3,500 words, 30 pages) and an oral presentation at the end of Term 1.
Terms 1, 2 & 3: Research Project Module (30 credits)
You will be required to carry out an independent research project on a relevant topic. You will be encouraged to suggest your own topic; ICTM staff will also suggest potential research projects.
In Term 1, you will formulate an idea or choose a topic from a range of subjects. Some examples of projects are included below:
- Literature-based dissertation: critical study of existing clinical trial methodology (any aspect of clinical trial design, conduct, analysis or reporting) and suggestions for improvement
- Action plan: literature review and plan for future clinical trial or study within a trial. The dissertation would include a background and rationale for the trial/question and a description of the proposed methodology and analysis methods (e.g. protocol)
- Primary research: literature review and quantitative and/or qualitative data collection and analysis, for which ethics board approval must be in place before student begins project (if required)
- Secondary data analysis: literature review and either secondary analysis of existing clinical trial data or meta-analysis of a number of published clinical trials
- Develop a piece of training to improve clinical trial design, conduct, analysis or reporting
- Perform an audit in line with the audit cycle for an existing trial or a systems-based audit at a site/clinical trials unit/clinical research facility/clinical research organisation: literature review and audit plan, report and follow-up
- Consider different monitoring strategies, their pros and cons for different trial designs, and suggest improved strategies (could include planning, performing and reporting on a monitoring visit/site initiation visit for a new trial using a novel monitoring strategy)
- Research governance related project e.g. perform a review of an area of existing guidance, identify areas of ambiguity or misinterpretation and suggest improvements/clarification
- Perform a service evaluation and determine whether improvements can be made or propose a new service based on new research
You will be encouraged to explore your ideas with lecturers on the course or discuss with the Programme Lead who will be able to suggest a potential ICTM supervisor.
During Term 1, you will be guided on how to write a research proposal, with IT training and library support provided throughout. You will finalise your proposal during Term 1 so that you are ready to undertake the practical aspects of your project during Term 2.
In Term 2, during week 1 of teaching you will present your project proposals. The rest of the term you will focus on your project work around lectures.
In Term 3, you will submit your dissertation (7,500 words).
To be eligible for registration, you must have satisfactorily completed the required programme of study and assessments for MBBS Years 1 and 2 at UCL or another UK Medical School.
For external candidates, visit the iBSc website