MRes Translational Medicine Academic year 2012/2013 Division of ...

MRes in Clinical Research (Pathway in Translational Medicine) - Academic Year 2012-2013Module 4: Specialist Module in Translational MedicineModule convenor: Dr V LibriThis module aims to further enhance student skills and knowledge in clinical research andtranslational medicine. A recurrent theme of this module is the use of biomarkers andpharmacodynamics endpoints in early phase exploratory studies to provide an initial indication ofwhether novel putative therapies may be sufficiently promising to justify the conduct of larger-scale,and longer-term, clinical trials. Consideration will also be given to human volunteer models andclinical study designs that may be used to either identify factors associated with risk, onset andprogression of diseases or to assess response to treatments and PK/PD relationships, which mayenhance predictability of drug efficacy in patients.The process of selection, development and validation of biomarkers will be emphasised withreference to specific diseases, including rare diseases, and the difficulties of studying drug efficacy insmall patient populations. Lectures will be integrated by practical sessions on the use and validity ofbiomarkers, surrogate endpoints, imaging and non-imaging technologies to advance drug discoveryand novel therapies. Alternative trial designs and advanced statistical methods of data analysis willalso be covered, as well as students will have the opportunity to shadow clinical trials at theWellcome Trust- McMichael Clinical Research Facility (WTMCRF).By the end of the module students will become familiar with the use of technologies in clinicalresearch, and the main principles underpinning the design and implementation of clinical trials forearly demonstration of drug efficacy based on conventional clinical endpoints and surrogate markersof diseases.Module details, including timetables will be available ahead of the module weeks.The research projectDuring the research period (one-year or two-year programme for full-time and part-time students,respectively), students are expected to design and undertake a research project. The purpose of theproject is to gain practical experience in supervised clinical and/or laboratory-based research.Students will be provided training in academic research and acquisition of practical skills, includingthe design of a research project, planning of experiments, dealing with practical problems,recording, presenting and analysing data. Research projects will comprise a literature survey on anassigned research area, preparation of a written report and presentation of proposed experimentalwork in seminars, conduct of experimental work and finally writing up of the thesis/manuscript.Students are expected to make an original contribution to the chosen area of research within thetime period allotted.Part-time students undertaking projects in their place of work will be required to have a local clinicalsupervisor (providing assistance and direction to projects on a day-to-day basis) and an ImperialCollege academic supervisor who will oversee the successful and timely implementation of theproject and will provide guidance on how to structure the final report.18