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MRes in Clinical Research (Pathway in Translational Medicine) - Academic Year 2012-2013Research Handbook for healthcare professionals. Mary Hickson. Blackwell Publishing, Chichester.2008https://www.myresearchproject.org.uk/ELearning/IRAS_E_learning.htmChapters 4,7,8,9,10,11,13 and 14 from "An Introduction to Medical Statistics" 3rd Edition, by MartinBland (published by Oxford University Press, 2000, ISBN 0192632698). http://wwwusers.york.ac.uk/~mb55/intro/introcon.htm"A Guide to Clinical Drug Research" 2nd Edition, edited by Adam Cohen and John Posner (publishedby Kluwer Academic Press, 2000, ISBN 0792361725)"Clinical Trials: A Practical Approach", by Stuart Pocock (published by Wiley, 1983, ISBN0471968838).Additional reading on Bench to Bedside, Clinical Trials and Experimental MedicineAnticipating change in drug development: the emerging era of translational medicine andtherapeutics. Nature Reviews, 4, 816-818. 2005Day M, Rutkowski JL, Feuerstein GZ. Translational medicine--a paradigm shift in moderndrug discovery and development: the role of biomarkers. Adv Exp Med Biol. 2009;655:1-12.How industry is approaching the search for new diagnostic markers and biomarkers. Zolg JW, LangenH. Mol Cell Proteomics. 3(4), 345-54. 2004Transgenic animal models in biomedical research. Houdebine LM. Methods Mol Biol. 360:163-202.2007Human Tissue Act: www.hta.gov.ukNRES guidance on safety reporting for CTIMPshttp://www.nres.npsa.nhs.uk/applications/after-ethical-review/safetyreports/safety-reports-forctimps/NRES guidance on information sheets and consent forms v3.5 May09.http://www.nres.npsa.nhs.uk/applications/guidance/#PISNRES information paper on informed consent in clinical trials of investigational medicinal productsv3 May 2008. http://www.nres.npsa.nhs.uk/applications/guidance/#InformedConsentNRES guidance on research involving adults unable to consent for themselves (incorporatingguidance on the Mental Capacity Act 2005).Multiple Choice Questions in Clinical Pharmacology. Timothy G K Mant, Lionel D Lewis and James MRitter. London, 2000Pharmacovigilance: MRC/DH joint project guidance notes on Pharmacovigilance. January 12 2007.http://www.ct-toolkit.ac.uk/_db/_documents/Joint_Project_Guidance_on_Pharmacovigilance.pdf38
MRes in Clinical Research (Pathway in Translational Medicine) - Academic Year 2012-2013EudraLex - Volume 10 Clinical trials guidelines chapter II - Monitoring and Pharmacovigilance.Detailed guidance on the collection, verification and presentation of adverse reaction reports arisingfrom clinical trials on medicinal products for human use. April 2006.http://ec.europa.eu/enterprise/pharmaceuticals/eudralex/vol-10/21_susar_rev2_2006_04_11.pdfThe Importance of Pharmacovigilance - Safety Monitoring of Medicinal Products. WHO. 2002.Clinical trials in gene therapy: ethics of informed consent and the future of experimental medicine.Lowenstein PR. Curr Opin Mol Ther. 10(5), 428-30. 2008Understanding Cancer Clinical Trials. (Cancer Backup, 2006)Applications of fMRI in translational medicine and clinical practice. Paul M. Matthews, Garry D.Honey and Edward T. Bullmore. Nature Reviews Neuroscience 7, 732-744. 2006Additional reading on TherapeuticsBiomarkers of Cardiovascular Disease: Molecular Basis and Practical Considerations. Vasan RS.Circulation. 2006; 113:2335-2362.H Watkins, H Ashrafian and W J McKenna. The genetics of hypetrophic cardiomyopathy. Heart 2008;94;1264-1268.Toward clinical risk assessment in hypertrophic cardiomyopathy with gadolinium cardiovascularmagnetic resonance. Moon JC, McKenna WJ, McCrohon JA, Elliott PM, Smith GC, Pennell DJ. J CmColl Cardiol. 2003 May 7; 41(9):1561-7Drug induced QT prolongation and torsades de pointes. Yap YG, Camm AJ. Heart. 2003 Nov;89(11):1363-72Cardiac physiology investigated by new methods of imaging. Neubauer S. Clin Med. 2007 Apr;7(2):189-91Molecular and metabolic imaging of atherosclerosis. Davies JR, Rudd JH, Weissberg PL. J Nucl Med.2004 Nov; 45(11):1898-907Proteomics and metabolomics combined in cardiovascular research. Mayr M, Madhu B, Xu Q. TrendsCardiovasc Med. 2007 Feb; 17(2):43-8Craven R. The risky business of drug development in neurology. Lancet Neurol. 2011Feb;10(2):116-7.Helmers SL, Phillips VL, Esper GJ. Translational medicine in neurology: the time is right.Arch Neurol. 2010 Oct;67(10):1263-6.Mangialasche F et al.. Alzheimer's disease:clinical trials and drug development. Lancet Neurol. 2010 Jul; 9(7):702-16.Brewer GJ. Drug development for orphan diseases in the context of personalizedmedicine.Trans Res. 2009 Dec;154(6):314-22. Epub 2009 Apr 23. Review.39
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