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UCL Institute of Clinical Trials and Methodology

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iBSc Clinical Trials

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.

Introduction

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.

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.

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.

Applications will open at the start of February for external candidates and will close on 31st March 2021. The course sits within a portfolio of undergraduate courses offered by the Division of Medicine, click here for further information.

Aims & Objectives

The scope of the programme is to teach MBBS students the:

  • Important concepts and practices required to ensure appropriate clinical trial design, conduct, analysis, and interpretation and reporting of results
  • Clinician’s viewpoint which will be incorporated in each of the modules
  • Roles and responsibilities of the clinical team which will be clearly defined, whilst exploring the logistics and challenges of trials nested within clinical practice
  • Clinical perspectives on trials by applying clinical trials design into practice
  • “Knowledge through practice” components of the programme will shape how the students approach clinical research, trials and clinical evidence throughout the MBBS programme and the rest of their career
Programme Structure

The course consist of five taught modules, one practical/log-based module and a research project. The speakers on the course are world leaders in clinical trials which have had impact not only on UK but also on international guidelines and impact on lives across the globe.

The teaching on the module will be delivered through a combination of lectures and tutorials. This will include the traditional face-to-face teaching and Lecturecast/audio recordings with interactive component including group discussions. The majority of teaching will be carried out by Institute of Clinical Trials and Methodology 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 students to relevant publicly available websites/links and to other relevant online learning materials to support the learning. The students will be encouraged to actively seek external sources related to the module content and discuss these in the classroom/online sessions. Click Here for the Programme overview.

Modules

Fundamentals of Clinical Trials (15 Credits)

Module organisers: Dr Angela Meade and Dr Almudena Sacristan Reviriego

Term 1

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 communicating the trial results 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 on the topic of: Identify a research question, justify the need for a trial to answer that question. Students will have to conduct research to justify the trial that they propose and provide evidence to support the trial, including an analysis of potential risks and benefits. The students will be expected to deliver a 15 minutes presentation with 15 minutes for questions.

Clinical Trials Design and Statistical Analysis (15 credits)

Module organisers: Dr Duncan Gilbert and Dr Hakim-Moulay Dehbi

Term 1

The module will outline trial design implications for a broad range of trial types across all phases, keeping students informed of innovations in trial design as appropriate. The students 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.

Clinical perspectives in trials (15 credits)

Module organisers: Dr Alejandro Arenas-Pinto and Dr Helen Meadows

Term 1

The module will outline how clinical research enhances standard of care and delineate the roles and responsibilities of the clinical team in clinical research. The module will guide the students to identify gaps in standard of care necessitating novel trials to 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 students the opportunity to practice their skills in research and enquiry, scholarly practice and professional skills and show their 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. This assessment will also help students prepare for writing up their project dissertations.

Systematic reviews and meta-analysis (15 credits)

Module organisers: Dr Claire Vale and Prof Jayne Tierney

Term 2

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 the students to understand, interpret and appraise published reviews. The role of systematic reviews and meta-analysis in practice, 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:

Students will be asked to complete an oral presentation to outline a question for a systematic review topic - a list of potential topics will be provided to the group. They will need to demonstrate a clear rationale and research objectives, explain the key inclusion and exclusion criteria and define outcome measures for the review. They will need to present their protocol orally in a 10 minute presentation with 5 minutes of Q&A.

Applying clinical trial design principles in practice (15 credits)

Module organisers: Dr Aleksandra Gentry-Maharaj and Dr Alejandro Arenas-Pinto

Term 2

This module will focus on students gaining 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.

Areas covered will include: 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).

Knowledge through practice (hands-on module) (15 credits)

Module organisers: Dr Aleksandra Gentry-Maharaj and Dr Alejandro Arenas-Pinto

Terms 1&2

This module will comprise of a log-book based activity where students are set tasks to complete based on the hands-on experience they have gained. Students will be invited to attend trial team and other Institute of Clinical Trials and Methodology meetings, seminars and events. They will also be invited to observe trial oversight committee meetings. These are the key components they would 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 (students 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.

Research Project (30 credits)

Module organisers: Dr Aleksandra Gentry-Maharaj, Dr Angela Meade and Dr Alejandro Arenas-Pinto

Terms 1, 2 & 3

The students will be required to carry out an independent research project on a relevant topic, either proposed by Institute of Clinical Trials and Methodology staff or by students themselves. Students will be encouraged to suggest their own topics and work with a supervisor to formulate a research question and agree on the appropriate methodology to answer it.

In Term 1, students will choose a topic from a range of subjects, including reviews of literature, collecting and/or analysing data sets to provide new information relevant to clinical trials or addressing challenges in trials. There is a wealth of data from the many ongoing trials at the Institute of Clinical Trials and Methodology. Research project could be based on trial data already collected as part of these trials and could focus on, for example, improving trial processes (e.g. use of electronic healthcare data in follow up of participants/ascertaining trial outcomes) or a secondary study addressing an aspect not previously explored. 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, perform and report 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 and 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

The students will be encouraged to explore their ideas with lecturers on the course or discuss with the Programme Lead who will be able to suggest a potential Institute of Clinical Trials and Methodology supervisor.

If required, the supervisor will ensure that ethical approval is obtained. The students will be expected to contribute to the writing of the ethics application and submission. This would be part of the detailed methodology of the project. If approval is not obtained in time, the Programme Lead will explore alternative options for the student’s project early on in Term 2.

During Term 1, the cohort will be guided on how to write a research proposal, with IT training and library support provided throughout. They will finalise their proposal during Term 1 so that they are ready to undertake the practical aspects of their project during Term 2.

In Term 2, during week 1 of teaching the students will present their project proposals. The rest of the term they will focus on their project work around their lectures which would be at the most be delivered over two days of the week.

In Term 3, the students will submit their dissertation (7,500 words).

Module assessment:

Essay (2,500 words) on a topic covered during the module, giving students the opportunity to practice their skills in research and enquiry, scholarly practice and professional skills and show their 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. This assessment will also help students prepare for writing up their project dissertations.Short answer questions on statistical concepts and their applicationDuring Term 1, the cohort will be guided on how to write a research proposal, with IT training and library support provided throughout. They will finalise their proposal during Term 1 so that they are ready to undertake the practical aspects of their project during Term 2.

In Term 2, during week 1 of teaching the students will present their project proposals. The rest of the term they will focus on their project work around their lectures which would be at the most be delivered over two days of the week.

In Term 3, the students will submit their dissertation (7,500 words).

Entry Requirements

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

Contact Details

If you have any queries regarding the programme then please contact our lead, Dr Alex Gentry-Maharaj ictm.ibscclinicaltrials@ucl.ac.uk or a.gentry-maharaj@ucl.ac.uk

For further information about the Institute please click here