Donato Bonifazi and Adriana Ceci, both members of our Board of Directors, have co-authored the research paper entitled: “Innovative research methodologies in the EU regulatory framework: an analysis of EMA qualification procedures from a pediatric perspective”, published on Frontiers in Medicine.
In this research paper, authors from CVBF, FGB and TEDDY, on behalf of EPTRI, analyzed the positive qualification opinions of novel methodologies for medicine development published on the EMA website between 2008 and 2023 to assess the potential pediatric interest in methodologies qualified as “novel methodologies for medicine development” by the EMA.
Authors found that despite most of the 27 qualifications for novel methodologies issued by the EMA (70%) were potentially of interest to pediatric patients, only six of them reported pediatric data. This represents a low number of studies specific for the paediatric population despite all the initiatives implemented by EMA to boost application of new and innovative methods in the research of medicines, especially in areas concerning small populations, such as rare diseases and pediatric subjects. Several measures are suggested by the authors to strengthen the research framework in the pediatric field to ensure the highest standards of care and safety for pediatric participants.
Full research article here.