To obtain clinical trial approval, a Clinical Trial Application must be submitted to regulatory bodies and a Research Ethics Committee who review the protocol and gives a positive or...
Compensation in clinical trials is not always a standard but may be offered to participants according to different models and in line with the respective legislation and regulations.
This article explores patient involvement in scientific regulatory committees in the EU, specifically in the activities of the European Medicines Association (EMA).
The term 'personalised medicine' includes both stratification and personalisation, which are often incorrectly used as synonyms. However, the two are different, as explained further below.
The starter kits provide you with links to relevant background reading in the toolbox and associated PowerPoint slide decks and media in order to prepare a single or multi-day...
Introduction Patients were asked by GlaxoSmithKline staff members to review a draft plain language summary from a completed Phase III study. The patients provided valuable feedback about the wording,...
Introduction Novo-Nordisk, a pharmaceutical company, does user research with patients to enhance understanding of patients and to develop products that meet users’ needs. Where in the process? – Phase...
Transcription My name is Tetiana Zamorska, I’m coming from Ukraine. I live in the capitol of Ukraine, Kiev. My son was born with a rare skin disorder called,...
Introduction A collaboration of Genzyme, International Pompe Association (IPA); UK, Dutch, and US Pompe patient organisations, Erasmus Medical Center and Duke University to establish appropriate measures to ensure the...