Safety of psychotropic medicines: looking beyond randomised evidence

Enhancing the quality and efficiency of regulatory science literature reviews through innovation and collaboration with library and information science experts

“…This can contribute to the need to identify appropriate vocabulary that accounts for foreign languages, spans all stages of development from pre-clinical to clinical studies, includes synonyms and older terms that have been replaced by more current terms, and captures all ways in which related products may be labeled. Furthermore, as the field of regulatory science has sought to include non-RCT evidence ( 1 – 7 ), additional vocabulary is needed to identify alternate study designs and data sources.…”

“…From large trials to follow-up case studies, capturing existing research is key to creating safe and effective regulatory policies. With a shift toward incorporating additional evidence-types—beyond randomized controlled trials (RCTs)—into regulatory decisions and the potential for literature reviews themselves to generate new data ( 1 – 7 ), the importance of high-quality literature reviews is increasing. However, rigorous and comprehensive literature reviews—that ensure important data are not missed ( 8 )—take substantial effort and can be difficult to do well.…”