Neurology's vital role in preventing unnecessary and potentially harmful pediatric studies
Source : https://www.tandfonline.com/doi/abs/10.1080/14737175.2022.2045953?journalCode=iern20
Abstract Regulatory authorities recognize two human populations: adults and children defined as <18 years. For drug approval, they demand separate studies. But humans mature slowly during puberty. The 18 th birthday is an administrative limit that does not correspond to a physiological change.
Expert opinion: Young patients with multiple sclerosis and other neurological diseases deserve studies with therapeutic intentions. “Pediatric” careers have emerged in academia, regulatory authorities, and pharmaceutical companies. Institutional Review Boards/ Ethics Committees should suspend questionable “pediatric” studies and reject newly submitted ones. The medical professions should distance themselves from questionable “pediatric” research that reflects massive conflicts of interest.