Policy

Gender issue in clinical trials in Europe

Internationally, the issue of including women in clinical trials of medicines has been addressed in various guidelines issued by the International Conference on Harmonization (ICH), which promotes regulatory standards for clinical trials. While ICH has specific guidelines on the conduct of clinical trials in paediatric and geriatric populations, there are no consolidated guidelines for the investigation of medicinal product in women.

In the wake of the 2009-2010 H1N1-pandemic, also known as the swine flu, a web of mistrust between the public and health authorities was spun. National pandemic plans were usually based on a single scenario that was more severe than the actual 2009 pandemic, and that was extrapolated from the severity of previous outbreaks like SARS and Avian flu. In effect the 2009 pandemic was nicknamed the false-pandemic or ‘the pandemic there never was’. However, national health authorities had declared a pandemic and bought vaccines for billions.

The exploration and adoption of best practices in health by public institutions and non-governmental organizations as well has been growing in recent years. ASSET experts recognize the importance of these activities. Thus, they will gather examples from all around Europe and present them on a dedicated page.

But what exactly are “best practices”, and what are the differences between best and good practices?

One day, eight countries, fifty participants for each of them, open discussions and a series of questions. These are the ingredients of the citizen consultations organized by ASSET on September 24^th, to voice people’s opinion on epidemic preparedness and response.