Phase II clinical studies, or proof of concept studies, begin to test the effect of a medicine on the target disease in humans. These studies are usually run as...
Developing medicines for children is important, but requires special measures to be taken during clinical development in order to shield children from undue risk.
The power of the patient voice is phenomenal, and inspires, motivates, informs, challenges and advises us during our awareness seminars. It may sound simple – share your experience and...
A medicine can be marketed in the European Union (EU) until the company has obtained a Marketing Authorisation (MA) for that medicine from the relevant regulatory authority. MAs are...
The processes of patient involvement in industry medicines research and development have evolved, but the evolution of frameworks, mechanisms, metrics and processes happens individually without much alignment and sharing.
A case report on Phase II patient involvement into Proof of Concept study design, to improve probability of success generating patient-relevant data and meeting current regulatory needs.
Involvement of the foundation ‘Children with SMA’ (spinal muscular atrophy) with an academic institution in Ukraine to design a pilot clinical trial addressing issues in SMA clinical trials.
Working with Community Advisory Boards: Guidance and tools for patient communities and pharmaceutical companies Background/Rationale for the document Community Advisory Boards (CABs) can improve research...
