Participate in this survey of paediatric clinical trials!
In Europe, the clinical development of medicines is highly regulated. In particular, the Clinical Trials Regulation (CTR) published in 2014 aims to create a favourable environment for the conduct of clinical trials in the European Union, with the highest safety standards for participants and greater transparency of trial information. This will increase the efficiency of all trials in Europe with the expectation of encouraging innovation and research while helping to avoid unnecessary duplication of trials.
As part of the provisions of the Regulation, the following are included:
- The implementation of consistent standards for conducting clinical trials across the European Union;
- Information on the authorisation, development and results of each clinical trial conducted in the European Union must be publicly available.
To this aim, the results of clinical trials must be made available to the public and, in particular, to the persons who participated in them through a summary in lay language, i.e. in a language that is comprehensible to the general public. Lay Language Summaries survey (LLSs) are generally delivered to clinical trial participants through the investigator and are available through specific websites established by the pharmaceutical industry.
The European Commission published a guide that provides sponsors and researchers with guidelines and templates for the production of abstracts of clinical trial results for lay people. In order to implement this guidance, and in particular to provide recommendations for clinical trials developed with the paediatric population, the European Patients' Forum (EPF), the European Forum for Good Clinical Practice (EFGCP) and the European Federation of Pharmaceutical Industries Associations (EFPIA) have created specific working groups. Specifically, the paediatric group has designed a questionnaire to collect information related to paediatric patients who have participated in a clinical trial. To this purpose, the following questionnaire has been designed, which we at Rare Commons encourage you to complete in order to collect information that will help make the summaries of results of paediatric clinical trials more user-friendly and comprehensible.