Teaching
Overview of the course:
The course is divided into taught and research components. The taught component is focussed in the Michaelmas term, including a series of face-to-face lectures, workshops, practicals, small group activities and online activities. The Lent and Easter terms primarily focus on completion of a research project, though small group tutorials and group presentation events will also be scheduled.
The taught component is divided into 4 modules, outlined below.
MODULE 1 - PRE-CLINICAL DEVELOPMENT
This module explores the later stages of basic scientific research, when a technology or therapy is nearing the point of clinical evaluation. It covers the ways in which efficacy and safety are evaluated, designs refined, and regulatory requirements met, as well as key considerations for leaders in the field such as intellectual property protection and team building.
MODULE 2 - CLINICAL TRIALS
This module covers clinical evaluation of new advanced therapies and medical devices, considering trial methodology and considerations specific to medical devices and first in human studies. Trial ethics, regulatory approval and monitoring will also be considered, along with how to engage patients, stakeholders and the media.
MODULE 3 - SCALE UP, IMPLEMENTATION AND COMMERCIALISATION
This module covers the key period when a validated device or advanced therapy can enter healthcare. Covering aspects of scale up, manufacturing and quality control, as well as considerations such as environmental sustainability and cost effectiveness. Key aspects of commercialisation are also covered, such as company building, dealing with investors and working with industry.
MODULE 4 - DATA ANALYSIS
The intended aims of this data analysis module are to provide training for evaluating novel interventions through pre-clinical and clinical trial stages. The curriculum will provide an overview of relevant statistical methods for leading clinical trials. The aim is to develop critical skills to appraise statistical writing and evaluate the quality based on a reasonable statistical intuition, run some simple statistical tests using ‘R’ and interpret the outputs.
The learning of transferable skills and researcher development training will be delivered by the course team (comprising Course Director, Course Research Lead, Programme Manager and Module Coordinators) and Biomedical Research Centre PIs, the MRC Biostatistics Unit, Cambridge Clinical Trials Unit, Cambridge BRC Patient and Public Involvement in Research team, Cambridge University Hospital's Clinical Engineering and Innovation, and the University’s Researcher Development Programme.
| One to one supervision |
Each student will have the opportunity to meet with the Course Director or Course Research Lead termly to discuss learning goals and progress. Students will be assigned to action learning sets of no more than 7 individuals to discuss shared and individual challenges, and to help develop and work on their projects in small learning communities. 9-12 hours per year are assigned to this Students will also be supervised in small groups for journal club sessions. During the research period, students will have regular meetings with their project supervisor. |
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| Seminars & classes |
Students will be provided with practical classes in small groups for the Data Analysis and Research Project teaching. Approximately 9 hours are assigned to these. |
| Lectures |
Approximately 100 hours of lectures will be provided during the course, with the course's limited intake allowing these to be interactive. |
| Practicals |
Practical experience will be gained from completing a research project with an experienced Principal Investigator. During the research project, we expect students to gain knowledge and skills in experimental design, experimental skills, data collection, data analysis and presentation. This training will be via receipt of project-specific training and by ongoing critical review of project progress with a Supervisor and potentially other members of the research group, where appropriate. Students will be embedded in the team of the Supervisor they are working with and will spend 24-32 hours per week on the project, for approximately 30 weeks. Students will be able to select their research topic from a list of proposed projects. Alternatively, if a student has a strong interest in a specific area, the course team will try to facilitate work in this area if a suitable Supervisor can be identified. |
| Posters and Presentations |
In the first term, students will present their project plan to their peers and supervisors, talking through a poster. In the following term, students will need to pitch a medical device and/or advanced therapy in a ‘Dragon’s Den’-style session and finally give an oral presentation of their work in a conference-style setting. To prepare for these events, the course incorporates teaching on the skills and techniques required to successfully present to both academic and lay audiences, in visual and oral formats, as well as the specific skills needed for a short, engaging pitch. |
| Taught/Research Balance |
Predominantly Taught
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Feedback
Various formative assignments and online tasks will consolidate learning. Students will receive termly supervision reports from the Course Director and will have the opportunity to provide self-evaluations.
Assessment
Thesis / Dissertation
In addition to the taught component of the course (October to December), students will embark on an individual research project, which will form 74% of the course assessment. Students will be provided with a range of potential research projects, working with Principal Investigators in a varied range of institutions, both within the University of Cambridge and beyond, including with relevant industry partners. In some circumstances, students may be able to set up their own project if a suitable Supervisor can be found.
The research project will be assessed by both a 10,000-word written thesis (comprised of two components) and an oral presentation:
Research project introduction - an introduction of the field providing background to, context for and the objectives of the research project. This will incorporate a literature review.
Final thesis – research project methods, results, discussion and conclusion.
Oral presentation – based on research project, presented at mini conference at the end of Easter Term.
Written examination
The taught component of the course will be assessed by two written examinations at the beginning of Lent Term.
Multiple Choice Question Exam - Assessment of modules 1-3 from Michaelmas Term taught material.
Data Analysis Exam - Application of knowledge from Module 4. Scored on the ability to conduct the relevant statistical analyses and the interpretation of results.
Other
Formative assessment:
Weekly online tasks during Michaelmas term to support lecture content.
Poster Presentation. Based on research project development ideas, presented at a seminar in the last week of Michaelmas Term, facilitating group feedback.
Research project introduction. Draft submitted for formative feedback.
Dragons Den Pitch. Presentation of a medical device or advanced therapeutic proposal to a panel of varied experts/ ‘investors’.