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UCL Institute of Clinical Trials and Methodology

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Modules

The following modules are offered by the ICTM:


    Introduction to Clinical Trial Designs and Statistical Analysis

     

    • Credit value: 30 credits 
    • Lecture time: 10 weeks (~60 hours)
    • Indicative workload: 300 hours

    At the end of the module students will be able to:

    • Choose the appropriate trial design and intervention in a range of disease settings.
    • Explain the phases of clinical trials, from early to late phase trials and associate appropriate populations and outcome measures with each phase.
    • Define and explain the principles of randomisation, blinding and bias in the context of randomised controlled trials.  
    • Propose methods to carry out randomisation and blinding and to prevent bias.
    • Calculate sample sizes for a given set of clinical trial assumptions and evaluate the impact of changes in those assumptions on trial size and duration.
    • Identify the components of a statistical analysis plan to be included in a clinical trial protocol.
    • Define and describe key statistical principles and their application in the analysis of clinical trials.
    • Analyse data in Stata (e.g. carry out simple descriptive statistics and time-to-event analysis).
    • Interpret results from analyses of clinical trial data.
    • Critique and appraise published clinical trials and systematic reviews.
    • Apply newfound knowledge to prepare a poster presentation to communicate the results of a clinical trial.

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    Protecting Patients and Introduction to Patient and Public Involvement

     

    • Credit value: 15 credits 
    • Lecture time: 5 weeks (~30 hours)
    • Indicative workload: 150 hours

    At the end of the module students will be able to:

    • Differentiate between appropriate and inappropriate trial conduct from ethical and regulatory perspectives.
    • Explain good clinical practice and recommend appropriate courses of action to ensure good practice is set out and adhered to in given clinical trial situations.
    • Evaluate good manufacturing and pharmacovigilance responsibilities for different types of IMP clinical trial and compose plans to manage those responsibilities.
    • Apply the appropriate clinical trial regulations to different patient populations and interventions to ensure patient safety and data integrity.
    • Recognise the value of patient and public involvement in clinical trial design and conduct. Analyse and reflect on scenarios where public involvement has helped/hindered clinical trial design/conduct.

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    Trial Set-up and Conduct - from an Idea to Reality

    • Credit value: 15 credits
    • Lecture time: 5 weeks (~30 hours)
    • Indicative workload: 150 hours

    At the end of the module students will be able to:

    • Explain the steps that must be completed to set up a clinical trial both centrally and at research sites (including the selection of sites).
    • Assess the risks associated with a given clinical trial and propose plans to mitigate those risks.
    • Plan a timeline for a clinical trial to aid project management (and hypothesise how different factors can impact on the trial timeline).
    • Illustrate the relationships involved in clinical trials; describe the importance of collaboration and good communication in successful trial conduct.
    • Compose CRFs to collect the appropriate data to ensure the outcome measures of different trials can be measured.
    • Construct/assess data management plans for a clinical trial.

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    Further Trial Designs and Outcomes

    • Credit value: 15 credits
    • Lecture time: 5 weeks (~30 hours)
    • Indicative workload: 150 hours

    At the end of the module students will be able to:

    • Define and describe different types of clinical trial design and their application.
    • Analyse different types of data using STATA and interpret and communicate the findings.
    • Identify and evaluate different questionnaires/measurement tools for assessing patient reported outcomes.
    • Appraise the relationships between the outcomes of a clinical trial and the costs associated with the intervention.
    • Formulate a plan to conduct a systematic reviews and meta-analysis.
    • Critique the findings from published systematic reviews and meta-analyses.

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    Applying Clinical Trial Design Principles in Practice

    • Credit value: 15 credits
    • Lecture time: 5 weeks (~30 hours)
    • Indicative workload: 150 hours

    At the end of the module students will be able to:

    • Compare and contrast requirements for clinical trial design and analysis in a range of different healthcare situations and with a range of different interventions.
    • Propose appropriate trial designs for a range of diseases / populations / interventions describing the strengths and weaknesses of different designs.
    • Recognise the complexities faced in carrying out clinical trials in a range of disease/population settings and propose solutions to particular challenges.
    • Propose critical findings from a clinical trial or systematic review and present to their peer group in a clear and succinct manner.

     

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    Managing Open Trials, Preparing for Analysis and Disseminating Trial Results

    • Credit value: 15 credits
    • Lecture time: 5 weeks (~30 hours)
    • Indicative workload: 150 hours

    At the end of the module students should be able to:

    • Identify possible data management risks and provide potential solutions.
    • Describe the importance of appropriate trial oversight and identify the roles and responsibilities of the trial team and other committees/stakeholders.
    • Identify the steps involved in closing a clinical trial. Formulate a plan of action to manage the premature (and unexpected) closure of a trial either for benefit, for harm or for lack of benefit/futility.
    • Recommend steps to encourage and enhance the involvement of patients and the public in trial oversight, the reporting of clinical trial results and the dissemination of clinical trial findings.
    • Communicate clinical trial results appropriately to different audiences.

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    Patient and Data Pathways through Clinical Trials

    • Credit value: 15 credits
    • Lecture time: 5 weeks (~30 hours)
    • Indicative workload: 150 hours

    At the end of the module students should be able to:

    • Propose methods to encourage participation in clinical trials by being able to recognise and describe motivations for, and barriers to, participation in trials (at individual and societal levels).
    • Recommend methods to ensure maximum compliance with treatment and follow-up within a trial protocol.
    • Explain the patient (and data) pathway throughout a clinical trial from screening, through treatment, follow-up and after trial care.
    • Describe the alignment and integration of translational/biological research into clinical trials to enable personalised/stratified treatment (including an introduction to the biology of disease where appropriate).
    • Identify and describe plans to implement patient and public involvement throughout the clinical trial process and beyond.

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    Project (MSc only)

    • Credit value: 60 credits
    • Lecture time: no teaching required, although students may need to attend meetings
    • Indicative workload: 600 hours

    Students taking the full MSc are required to complete an independent research project under the supervision of an ICTM researcher. The project module is assessed as follows:

    • Project proposal (2,500 words): The ability to design a study proposal is a key aspect in clinical trials and it is the initial stage of clinical trial design. Academic organisations, pharma, funders and regulators will all often review project proposals prior to giving their approval for a clinical trial to commence. This element of assessment will give students the opportunity to develop and demonstrate their skills in designing, proposing and justifying a study.
    • Oral presentation (20 minutes): The ability to communicate confidently and effectively to different audiences, to study team members, colleagues and collaborators is essential for all members of a clinical trial team. This element will give students the opportunity to become confident in presenting and communicating their work preparing them for the workplace.
    • Journal paper (6,000 words): Writing a report in the style of a journal paper will allow students to improve their writing skills becoming more efficient, succinct and professional in their approach. This is an essential skill in the field of clinical trials. Production of at least one manuscript describing the key clinical trial methods and results is one of the expected outputs of all clinical trials.

    By the end of the research project students will be able to:

    • Develop and design a research project
    • Effectively manage a research project applying both project and time management skills
    • Analyse and evaluate findings from their research
    • Write up and present findings clearly and concisely
    • Summarise key findings from their research and place it in context of the relevant field of research

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