Graduate School of health and Medical Sciences

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An Introduction to the Theory and Practice of Clinical Trials
Provider: Faculty of Health and Medical Sciences

Activity no.: 3345-23-00-00
	Enrollment deadline: 03/02/2023

Date and time	02.03.2023, at: 10:00 - 17:00
Regular seats	43
Course fee	720.00 kr.
Lecturers	Paul Blanche
ECTS credits	0.70

Contact person	Susanne Kragskov Laupstad E-mail address: skl@sund.ku.dk

Enrolment Handling/Course Organiser	PhD administration SUND E-mail address: phdkursus@sund.ku.dk

Enrolment guidelines This is a generic course. This means that the course is reserved for PhD students at the Graduate School of Health and Medical Sciences at UCPH. Anyone can apply for the course, but if you are not a PhD student at the Graduate School, you will be placed on the waiting list until enrollment deadline. After the enrollment deadline, available seats will be allocated to the waiting list. The course is free of charge for PhD students at Danish universities (except Copenhagen Business School), and for PhD students at NorDoc member universities. All other participants must pay the course fee. Learning objectives A student who has met the objectives of the course will be able to: 1. understand the basics of clinical trial protocols and clinical trial reports. 2. ask critical questions regarding trial design. Content This course is based on the author’s monograph Statistical Issues in Drug Development (3rd edition, 2021) and his extensive experience working within and consulting for the pharmaceutical industry. It will explain methodological ideas that underpin clinical trials and practical issues in implementing them. It should appeal to non-statisticians who wish to gain an intuitive understanding of statistical issues related to clinical trial practice but also to statisticians who wish to understand practical problems that trialists face. Details: This one day course will consist of four lectures and associated question and answer (Q&A) sessions. The lecture content will total four hours and the Q&A session will total 2 hours. Lecture 1: Control, randomisation and blinding. Why is concurrent control valuable? Trend effects, study effects, regression to the mean. Should patients in a clinical trial be representative? How are patients allocated to treatment? What is the point of randomisation? How is randomisation carried out? How are clinical trials blinded? What is the purpose of placebos? The double dummy technique. Double dummy loading. The TARGET study as an example. When is blinding inappropriate? Should we test blinding by asking patients if they can identify the treatment? Lecture 2: The measurement of treatment effects. Scales commonly used. Why dichotomisation is a bad idea. Risk differences, relative risks, odds-ratios, hazard rates. The example of bioequivalence studies. The example of vaccine efficacy trials. Transferability of results. The Pfizer/BioNTech COVID vaccine efficacy trial as an example. Measures of uncertainty. Lecture 3: The use of covariate information. Baselines. Placebo run-ins. Why change scores (also known as gain scores) are a bad idea. Why percentage change from baseline is an even worse idea. Stratification. Analysis of covariances. Why responder analysis should be avoided. Why personalised medicine is overhyped. Lecture 4: Some examples and some lessons. The Lanarkshire Milk Experiment as a historical example. What does it teach us about the value of concurrent control? The Shumaker and Metzler phenytoin study. What does it teach us about personal response? MTA/02: an example of a complex study. Pre-requisites: A basic understanding of high school algebra and very elementary statistics would be an advantage. However, the course itself will be very light on algebra and concepts will mainly be explained verbally, by analogy and graphically. Participants Ph.D. students and visiting researchers. Max. 40 participants. Relevance to graduate programmes The course is relevant to PhD students from the following graduate programmes at the Graduate School of Health and Medical Sciences, UCPH: - All graduate programmes Language English Form Lectures and associated question and answer (Q&A) sessions Course director Associate professor Paul Blanche Teachers Professor Stephen Senn (Statistical Consultant, self-employed, and University of Sheffield, UK). Stephen Senn has worked as a statistician but also as an academic in various positions in Switzerland, Scotland, England, France and Luxembourg. From 2011-2018 he was head of the Competence Center for Methodology and Statistics at the Luxembourg Institute of Health. He is the author of Cross-over Trials in Clinical Research (1993, 2002), Statistical Issues in Drug Development (1997, 2007,2021), Dicing with Death (2003, 2022). In 2009 was awarded the Bradford Hill Medal of the Royal Statistical Society. In 2017 he gave the Fisher Memorial Lecture. He is an honorary life member of PSI (Statisticians in the Pharmaceutical Industry) and ISCB (International Society For Clinical Biostatistics). Dates 2 March 2023, from 10-17. Course location CSS Registration Please register before 3 February 2023 Expected frequency Only once Seats to PhD students from other Danish universities will be allocated on a first-come, first-served basis and according to the applicable rules. Applications from other participants will be considered after the last day of enrolment. Note: All applicants are asked to submit invoice details in case of no-show, late cancellation or obligation to pay the course fee (typically non-PhD students). If you are a PhD student, your participation in the course must be in agreement with your principal supervisor.

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