Author Archives: kjell

Module 4: The European regulatory framework and drug approval process

The EU regulatory system for medicines The European medicines regulatory system is based on a network of around 50 regulatory authorities from the 31 EEA countries (28 EU Member States plus Iceland, Liechtenstein and Norway), the European Commission and the European Medicines Agency (EMA). This network is what makes the EU regulatory system unique. The network is supported by a […]

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Module 3: Statistics in clinical trials

Using statistics in research Statistical methods provide a way for formally accounting for sources of variability in patients’ responses to treatment. The use of statistics allows the clinical researcher to form reasonable and accurate inferences from collected information, and make sound decisions in the presence of uncertainty. Statistics are key to preventing errors and biases in medical research.  Hypothesis Testing A hypothesis […]

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Module 2: Clinical trials: types, designs and methods

What is a clinical trial? A clinical trial is a clinical study in which participants are assigned according to a pre-defined therapeutic strategy or plan (protocol) to receive a health-related intervention, such as a medicine, in order to investigate its effects on health outcomes, usually compared to another (or sometimes no) treatment. Clinical trials are used to evaluate clinical practices […]

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Pan-European survey of patient perception of unmet need and value drivers in NSCLC

A pan-European survey is being conducted with the aim to understand the following about people’s experience with non-small cell lung cancer (NSCLC), with the overall aim of better understanding experience during the care pathway, as well as needs and expectations in terms of innovative treatments. More specifically, the survey will explore:  perception of the disease burden on the daily life […]

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