In the month of June, the European Commission has launched four new public consultations on clinical trials. The consultations are on risk proportionate approaches, on the summary of the clinical trials results for a lay person, on the definition of investigational medicinal products and the use of auxiliary medicinal products, and on ethical considerations of clinical trials with minors. All consultations can be found here and are open until the 31st August to all citizens and interested organisations.
The consultation can be accessed here: http://ec.europa.eu/health/files/clinicaltrials/2016_06_pc_guidelines/gl_4_consult.pdf
Contributions should be submitted by August 31st to: This email address is being protected from spambots. You need JavaScript enabled to view it.
EFA has been advocating together with the European Patients’ Forum (EPF) for a legislation on clinical trials that is transparent and safe for patients and that involve them as much as possible. We will respond to the consultation and we will have a special focus on the summary of the clinical trial results for lay persons, which has been developed by the expert group on clinical trials in preparation for the implementation for the Clinical Trials Regulation (EU) No 536/2014.