Introduction An example of patient involvement looking at a case report on Phase III patient involvement in an advisory board comprising six expert GYN oncology nurses from across Europe...
Patient Engagement in Early Dialogues: Tools and resources for HTA bodies Background/Rationale Early Dialogues with regulators and health technology assessment (HTA) bodies are a well-established processes in which medicines...
Health-related Quality of Life (HRQoL) measures provide important information about the added value of a health technology and are often used to support decision-making in Health Technology Assessment (HTA)...
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 François. I’m 51. I work for the European organisation for rare disease EURORDIS, where my main role is to help patients navigating through the different procedures for...
Research Ethics Committees (RECs) evaluate the ethical acceptability of research before participants can be enrolled in a study. RECs are highly regulated, neutral bodies which operate according to standard...
A very important result from the EUPATI project was the development, broad consultation and final release of guidances on the best approach to interaction of patients with pharmaceutical industry-led...
Special considerations must be taken into account in the development of paediatric medicine, including in terms of research and trial design and ethical concerns.
Phase III clinical studies, or confirmatory studies, are the final confirmation of the safety and efficacy of a medicine before it can be launched on the market. Phase III...
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