An Experimental Cancer Medicine Centre

MEDN66201 An Experimental Cancer Medicine Centre 15 Semester 1 Postgraduate Taught Level 6 Andrew Hughes Unit coordinator Division of Cancer Sciences 1 FHEQ level (Framework for Higher Education Qualifications) ' Masters/Integrated Masters P4 ' European Credit Transfer & Accumulation System Rating : 7.5 “An Experimental Cancer Medicine Unit” unit is a 15 credit, interactive blended learning unit which will give you a comprehensive introduction to the clinical trial and clinical research portfolio of a Phase 1 unit, together with how a Phase 1 unit is structured and functions within the context of a  highly matrixed clinical research environment.The unit is a blended combination of lectures, workshops and on-line material.Part A (The Clinical Trial Portfolio for an Experimental Cancer Unit) is designed to cover topics relating to the types of human clinical trials conducted by a “Phase 1” unit. Part B (The Clinical Research Portfolio of an Experimental Cancer unit) is designed to provide students with the clinical research which can be conducted by a Phase I unit in parallel with conducting clinical trials. Part C (The Anatomy and Physiology of an Experimental Cancer Medicine Unit) will equip students as to the importance of metrics, business cases, funding sources and facilities to the smooth running of an experimental cancer medicine unit. “An Experimental Cancer Medicine Unit” unit is a 15 credit, interactive blended learning unit which will give you a comprehensive introduction to the clinical trial and clinical research portfolio of a Phase 1 unit, together with how a Phase 1 unit is structured and functions within the context of a  highly matrixed clinical research environment.The unit is a blended combination of lectures, workshops and on-line material.Part A (The Clinical Trial Portfolio for an Experimental Cancer Unit) is designed to cover topics relating to the types of human clinical trials conducted by a “Phase 1” unit. Part B (The Clinical Research Portfolio of an Experimental Cancer unit) is designed to provide students with the clinical research which can be conducted by a Phase I unit in parallel with conducting clinical trials. Part C (The Anatomy and Physiology of an Experimental Cancer Medicine Unit) will equip students as to the importance of metrics, business cases, funding sources and facilities to the smooth running of an experimental cancer medicine unit. The purpose of Part A is to provide a foundation and appreciation of what comprises a “Phase 1” trial- ie a trial of “non-therapeutic intent”. Specifically, four types of studies fall into the category of studies where the primary endpoint/intent is not characterization of efficacy – but rather the characterization of toxicity (First in human and first in combination clinical trials), characterization of pharmacokinetics (regulatory clinical pharmacology studies) and characterization of the relevance of human target (using tissue collections or microdosing).The purpose of Part B is to provide a foundation and appreciation of how an functional experimental cancer medicines unit also needs to have an active research portfolio- to contribute to the advancement of the science of clinical research. How the research portfolio is selected and prioritized and then embedded into the clinical trials portfolio is a key learning from Part B.The purpose of Part C is to provide a foundation and appreciation of the structure and function of an experimental cancer medicines unit. Four critical but interconnected cornerstones are needed- a facility, staff, acquiring trials and acquiring patients. Students will gain an understanding as to how these are inter-dependent and also how to develop realistic plans for each of the cornerstones. 1.         The Clinical Trial Portfolio for an Experimental Cancer UnitILO's:Basic introduction to types of Phase I trialsOverview of designs for the first in man and first in combination administration trialsDefinition of Phase 0 studiesHuman tissue validation using tissue and microdosing techniquesDetermination of pharmacokinetic endpoints in regulatory clinical pharmacology studiesFactors influencing the absorption, distribution, metabolism and elimination of drugsOverview of designs for regulatory clinical pharmacology studies 2.         The Clinical Research Portfolio of an Experimental Cancer unitILOs:To understand the concept of “precision medicine”To understand the merits and challenges of precision medicine being conducted by “virtual biopsy”To understand methods for “real time data capture and visualization” and the pros and cons versus traditional methods of pen and paper and hand curationTo understand the highly matrixed nature of clinical research- within Manchester, within the UK and Globally 3.         The Anatomy and Physiology of an Experimental Cancer Medicine UnitILOs:To understand what makes a compelling business caseTo understand the value of measuring research outputsTo understand requirements for a facility to conduct clinical researchTo understand how to secure trials from academia and pharmaTo understand where patient referrals come from and how to facilitate referral patternsTo develop skills to estimate safe staffing levels for a clinical research facility Analytical skills through data interpretation and literature review Group/team working through delivering research projects to dissertation standards Innovation/creativity through designing a plan for clinical research projects Leadership taking ownership for defining then delivering then interpreting then communicating research Project management of two research projects- RP1 and RP2 at 60 credits each Oral communication by summative course assessments Problem solving through engagement with patients cancer disease Research the fundamental basis of the year programme Written communication by summative course assessments Other through awareness and engagement with life-skills courses at Manchester library A range of teaching, learning and assessments are utilised in order to assess the students’ knowledge, understanding, and developing intellectual and practical skills. Summative assessments include a variety of reports (e.g., strategies, plans, audits) literature reviews, critical appraisals/reviews of published work/government guidelines and presentation of different types of work.The programme also places an emphasis on group work as this a vital skill for persons operating in a multi-disciplinary area such as experimental cancer medicine, and this is shown in the teaching methods and assignments.  Each experimental cancer medicine specific unit has different emphasis on the group work assessment based on the nature of the material being covered; how they are to apply the knowledge and the work they are to complete. Written assignments based on problem-solving work assess the students’ ability to gather information from a wide range of sources, evaluate and critically analyse information, make considered judgements about that information and synthesise material into logical and coherent pieces of work. Analytical assignments prepare students on practical skills gained from the course. All assignments also assess the ability of students to develop their knowledge and understanding of underpinning subjects, concepts and theories. On-going, formative assessment and feedback to students is a key feature of the learning materials for this programme. Students will be required to engage in a wide range of interactive exercises to enhance their learning and test their developing knowledge, understanding and skills via eLearning.  In addition, feedback on work is provided in the F2F workshops.  2 Written assignment (inc essay) 100% Feedback on assessed work is given to students via Turnitin.Student feedback is the central aspect of how the programmes are organised and developed. Feedback mechanisms include the following:   I.        Student representation from each year of the programmes on the MRes in Experimental Cancer Medicine Programme Committee   II.        Online feedback questionnaire on which students rate the quality of teaching in terms of delivery, handouts, presentation etc. MRes Experimental Cancer Med MRes Experimental Cancer Med PGDT Taught Component Mandatory N Lectures 50 0 100