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In August we sent our comments to the European Commission open consultation on the summary of results of clinical trials for laypersons.

This consultation follows the new clinical trials regulation that states that sponsors will have to publish the results of the clinical trials in an EU data base within one year time after the end of the trial.

While the preliminary text of the Commission is very detailed, EFA underlined the need to take into consideration patients’ views at any stage of the clinical trial, from the design to the dissemination of results because involving people with allergy, asthma and COPD would lead to have a clear and understandable summary of the results by a layperson.

EFA made recommendations not only about how to put the information to patients, but also what to put and how to refer it so that indexation of clinical trial results can be easily found by patients (by disease, comorbidities, results). We also encourage sponsors to systematically inform all the individuals involved in clinical trials unless specifically opposed to be contacted. 

The complete EFA's response to the consultations is here

Please visit our dedicated clinical trial section to know more. 

Tags: Category: News,Position paper
Country: EU
Theme: - Clinical trials