Features

The second edition of the ASSET best practice award for general practitioners has come to an end, with the assignment of the four grants to health professionals or groups of health professionals working in the primary health sector.

Last January, the scientific journal Nature published a news about scientists who do research funded by the Gates Foundation, who are not allowed to publish their work in those journals that do not comply with the Foundation’s open-access policy. This is the case of important publications such as Nature, Science and the New England Journal of Medicine (NEJM).

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.

Drug Approval Regulation in Canada and USA

Since the thalidomide tragedy in the late1950s, there has been a reluctance to include women of childbearing age in clinical trials. However, this fear cannot be used as an excuse to not include females in clinical trials, and, with proper care and regulation, increased female participation has been reached. The United States adopted regulation early on to increase the participation of women, while a new regulation in Europe is going to improve this as well. Here follows an overview of the issue in Canada and in the USA. The third part of this series will deal with new regulation in Europe.