Inadequate reporting quality of registered genome editing trials: an observational study.

ABSTRACT:

Background

To assess registration completeness and safety data of trials on human genome editing (HGE) reported in primary registries and published in journals, as HGE has safety and ethical problems, including the risk of undesirable and unpredictable outcomes. Registration transparency has not been evaluated for clinical trials using these novel and revolutionary techniques in human participants.

Methods

Observational study of trials involving engineered site-specific nucleases and long-term follow-up observations, identified from the WHO ICTRP HGE Registry in November 2020 and two comprehensive reviews published in the same year. Registration and adverse events (AEs) information were collected from public registries and matching publications. Published data were extracted

SUBMITTER: Juric D 

PROVIDER: S-EPMC9063127 | biostudies-literature | 2022 May

REPOSITORIES: biostudies-literature