Phase I clinical studies, or proof of mechanism studies, test the safety of a medicine in humans. Usually, these studies are carried out in healthy human volunteers.
Special considerations must be taken into account in the development of paediatric medicine, including in terms of research and trial design and ethical concerns.
Transcription My name is Pauline Kitchiner, and I work at GSK’s Clinical Unit in Cambridge. Which is a purpose built clinical unit to conduct phase one or phase...
Transcript * this transcription has been done with the help of AI. What is a clinical research study? For many of us, being diagnosed with a serious...
Introduction A case report on the inclusion of a patient expert on a pharmaceutical company’s external Bioethics Advisory Panel. The patient expert was proposed to the existing panel so...
Transcription My name is Dimitrios Athanasiou. I am a parent of a child with Duchenne muscular dystrophy. I am a full-time patient advocate for Duchenne and rare diseases,...
Transcription I’m Dominique Hamerlijnck. I’m one of the patient advocates from the Dutch Lung Foundation. We do quite a lot of different projects, and usually it goes two...
‘Within-trial decisions’ are decisions made once a clinical trial has already begun, for instance if an unexpected problem comes to light. This article looks at two specific kinds of...
Participants of clinical trials have rights that are protected by law, and they also have specific responsibilities. Participants' organisations have close relationships with the patients in a clinical trial...
Authors: Oyiza Momoh, Susan W. Burriss, Anya Harry, Kay Warner The importance of inclusion and diversity in clinical trials It is important that people participating in clinical trials...
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