Clinical trial results are recorded in a clinical study report (CSR) in a prescribed manner; however, access to the CSR is usually limited. Summarised information from the CSR comes...
Transcription My name is Luís Mendão. I’m Portuguese, 58. I live with AIDS. I was until recently co-infected with hepatitis C. Hepatitis C was a very advanced liver...
Small populations present ethical and practical challenges to organising clinical trials. Small populations include groups with rare diseases or specific sub-types of common diseases, children, and the elderly.
Introduction Partners from Ethic Committees (National Commission of Ethic Committees – CNCP), patient associations, and investigating centres worked in a writer’s guide of five recommendations and six rules for...
Access here the original research paper. Background/Rationale for the document: Capturing the ‘return on engagement’ is complex, given the many factors that influence the impact of patient engagement. This Patient Engagement...
In the current Clinical Trials Directive, the definition of conditions for inclusion of vulnerable populations is limited to clinical trials with minors and incapacitated adults who are not able...
Transcription My name is Jan Geissler. I’m a patient advocate now for fifteen years. I’ve been diagnosed with chronic myeloid leukemia in 2001. At that time, diagnosis really...
There are several kinds of bias that may occur in clinical trials, including selection, measurement, and publication bias. Statistics are used in clinical trials in order to avoid or...
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