MRes Translational Medicine Academic year 2012/2013 Division of ...
MRes Translational Medicine Academic year 2012/2013 Division of ... MRes Translational Medicine Academic year 2012/2013 Division of ...
MRes in Clinical Research (Pathway in Translational Medicine) - Academic Year 2012-2013Welcome week(1 st – 5 th Oct 2012)Core Module 1(8 th -12 th October 2012)Core Module 2(14 th – 18 th Jan 2013)Core Module 3(18 th – 22 rd March 2013)Pathway specific Module 4(13 th – 17 th May 2013)Inductions (Heath and Safety; Security Badges;Library),Introductory talksProjects discussion.Introduction to Clinical ResearchMedical GovernanceCritical AppraisalMedical StatisticsBench to BedsideClinical Trial Design and ImplementationClinical and Experimental Medicine Tools in ClinicalResearchTherapeutics (inflammatory, cardiovascular,respiratory, metabolic, oncology and neuropsychiatricdiseases.Specialist Module (Translational Medicine)1 st Exam(3 rd Dec2012)2 nd Exam(Mar/April2013)3 rd Exam(June 2013)Part-time students can choose to attend all modules and relative exams during the first year of thecourse or they can choose to; Attend core modules 1 and 2 during year 1 (and sit the first written exam during the sameyear) Attend core module 3 and specialist module 4 during year 2 and sit the second and thirdwritten exams during the second year of the course.Module 1: Introduction to Clinical Research, Governance and Medical StatisticsModule convenors: Dr Karen Mosley, Dr Mary Hickson, Dr Les HusonThe first three days of the module, along with a compulsory e-learning element (see page 18/19),aim to provide students with a thorough grounding in the methods required to design andimplement a clinical research study. The module also covers all aspects of Good Clinical Practice(GCP) and regulatory requirements and provides students with the necessary tools to facilitate aclinical research project from conception to end of study. A workshop with the library will cover thecriteria for searching the literature in a systematic and comprehensive manner and a workshop oncritical appraisal will cover how to critically evaluate research papers to confidently identify robustand valid published literature.During the second part of the module (days 4 and 5) students will learn basic statistical skills to carryout descriptive data analysis, to estimate parameters such as means and variances, and to carry outand interpret hypothesis tests. Statistical concepts covered in this module will include randomisationand blinding, sample size calculations and specific types of statistical significance test comparingmeans and medians, proportions, type I and type II errors, p-values, confidence intervals, simplelinear regression and correlation analysis. Lectures will be complemented by a number of practicalclasses on data analysis.Dr Les Huson will be available for one-to-one discussions of any statistical issue arising during thecourse of your work, and in particular issues connected with your project. To book a session pleasecontact Dr Huson via email - (l.huson@imperial.ac.uk).16
MRes in Clinical Research (Pathway in Translational Medicine) - Academic Year 2012-2013Module 2: Bench to Bedside, Clinical Trials and Experimental Medicine ToolsModule convenors: Dr V Libri, Dr Rohini Sharma, Dr Roberto DinaThis module will focus on the key elements of clinical research and the role of surrogate markers andemerging technologies in drug development, from preclinical discovery through first-time-in-human(FTIH) studies and early phase clinical trials in patients. Advantages and limitations of animal modelsof diseases, principles of pharmacokinetics, prediction of likely therapeutic doses, extrapolation ofpreclinical findings to human diseases and the clinical applicability/validity of marker endpoints willbe covered. Lectures will also give an overview of the classification and staging of cancer and thespecific pathways required for the development of oncology drugs.The module will cover a wide range of topics in the following areas: Preclinical Research (e.g. principles of drug discovery; gene expression pharmacogenomicsand proteomics; animal models of diseases) Drug Development (e.g. target identification and candidate molecule selection; preclinicalassessment of drug toxicity; FTIH and proof-of-concept (POC) studies; patients selection;principles of pharmacokinetics; surrogate biomarkers and safety markers) Imaging and Experimental Medicine Technologies (e.g. magnetic resonance imaging;positron emission tomography and radiotracers; spectroscopy and other imaging modalities)Module 3: TherapeuticsModule convenors: Dr V Libri, Dr Rohini Sharma, Prof Gary Frost and Dr Mary HicksonThis module will introduce students to the complexity of clinical trials in across a broad range ofhuman diseases, including inflammatory, cardiovascular, respiratory, metabolic medicine, oncologyand neuro-psychiatric diseases. The purpose is to allow students to gain a thorough understandingof the challenges in setting up clinical trials in these therapeutic areas. Alongside basic principles andchallenges of diseases, emphasis will be put on the cutting edge of novel clinical endpoints,emerging platform technologies and clinical biomarkers.Teaching is designed to allow students to gain a comprehensive understanding of the basicpathological processes and diagnostic techniques used in the assessment of the above diseases.Lectures will be complemented by a number of sessions on diagnostic methods to provideunderstanding of the main areas of investigation in clinical practice and on the use of morphologicaland molecular techniques in the understanding of human diseases. Among other topics, lectures willprovide knowledge of tests and procedures used in the diagnosis, prognosis and treatment of cancerand their application to oncology trials. The objectives of these sessions are to prepare students forthe planning and management of clinical trials and studies in the area of oncology while providingthe necessary knowledge and skills to also meet the potentially complex and sensitive needs of theoncology patient.By the end of the module, students will have an enhanced awareness of the challenges andcomplexity of specific human pathologies and will be able to recognise and exploit potential enablingtechnologies within the context of clinical trials.17
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<strong>MRes</strong> in Clinical Research (Pathway in <strong>Translational</strong> <strong>Medicine</strong>) - <strong>Academic</strong> Year <strong>2012</strong>-<strong>2013</strong>Module 2: Bench to Bedside, Clinical Trials and Experimental <strong>Medicine</strong> ToolsModule convenors: Dr V Libri, Dr Rohini Sharma, Dr Roberto DinaThis module will focus on the key elements <strong>of</strong> clinical research and the role <strong>of</strong> surrogate markers andemerging technologies in drug development, from preclinical discovery through first-time-in-human(FTIH) studies and early phase clinical trials in patients. Advantages and limitations <strong>of</strong> animal models<strong>of</strong> diseases, principles <strong>of</strong> pharmacokinetics, prediction <strong>of</strong> likely therapeutic doses, extrapolation <strong>of</strong>preclinical findings to human diseases and the clinical applicability/validity <strong>of</strong> marker endpoints willbe covered. Lectures will also give an overview <strong>of</strong> the classification and staging <strong>of</strong> cancer and thespecific pathways required for the development <strong>of</strong> oncology drugs.The module will cover a wide range <strong>of</strong> topics in the following areas: Preclinical Research (e.g. principles <strong>of</strong> drug discovery; gene expression pharmacogenomicsand proteomics; animal models <strong>of</strong> diseases) Drug Development (e.g. target identification and candidate molecule selection; preclinicalassessment <strong>of</strong> drug toxicity; FTIH and pro<strong>of</strong>-<strong>of</strong>-concept (POC) studies; patients selection;principles <strong>of</strong> pharmacokinetics; surrogate biomarkers and safety markers) Imaging and Experimental <strong>Medicine</strong> Technologies (e.g. magnetic resonance imaging;positron emission tomography and radiotracers; spectroscopy and other imaging modalities)Module 3: TherapeuticsModule convenors: Dr V Libri, Dr Rohini Sharma, Pr<strong>of</strong> Gary Frost and Dr Mary HicksonThis module will introduce students to the complexity <strong>of</strong> clinical trials in across a broad range <strong>of</strong>human diseases, including inflammatory, cardiovascular, respiratory, metabolic medicine, oncologyand neuro-psychiatric diseases. The purpose is to allow students to gain a thorough understanding<strong>of</strong> the challenges in setting up clinical trials in these therapeutic areas. Alongside basic principles andchallenges <strong>of</strong> diseases, emphasis will be put on the cutting edge <strong>of</strong> novel clinical endpoints,emerging platform technologies and clinical biomarkers.Teaching is designed to allow students to gain a comprehensive understanding <strong>of</strong> the basicpathological processes and diagnostic techniques used in the assessment <strong>of</strong> the above diseases.Lectures will be complemented by a number <strong>of</strong> sessions on diagnostic methods to provideunderstanding <strong>of</strong> the main areas <strong>of</strong> investigation in clinical practice and on the use <strong>of</strong> morphologicaland molecular techniques in the understanding <strong>of</strong> human diseases. Among other topics, lectures willprovide knowledge <strong>of</strong> tests and procedures used in the diagnosis, prognosis and treatment <strong>of</strong> cancerand their application to oncology trials. The objectives <strong>of</strong> these sessions are to prepare students forthe planning and management <strong>of</strong> clinical trials and studies in the area <strong>of</strong> oncology while providingthe necessary knowledge and skills to also meet the potentially complex and sensitive needs <strong>of</strong> theoncology patient.By the end <strong>of</strong> the module, students will have an enhanced awareness <strong>of</strong> the challenges andcomplexity <strong>of</strong> specific human pathologies and will be able to recognise and exploit potential enablingtechnologies within the context <strong>of</strong> clinical trials.17
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