Clinical trials – research studies involving human participants – are critical and essential steps in bringing new medicines to patients and to evaluate the efficacy and safety of these drugs. These studies also provide important information needed to obtain approval from governmental health authorities in order to bring new products to a diverse population of people in dire need. Therefore, our commitment is to conduct clinical research in a way that promotes mutual trust between patients, physicians, Gedeon Richter as the pharma company, local ethics committees and governmental authorities. 

The company commits to implementing specific measures to protect vulnerable clinical trial participants. These measures include special attention on age-appropiate language in child assent as well as animated video and easy-to-understand material to explain study details to participants and caregivers. Several design elements are introduced to minimize participants’ exposure to the study drug if the study is futile, regular evaluation of emerging data is performed by an independent data monitoring committee, and homecare visits are made to minimize the burden on participants. Regarding privacy and confidentiality, special attention is paid to protecting the data and identity of participants.