CIOMS cited

Based on the discussions at the inaugural WHO Global Clinical Trials Forum in November, 2023, a rapid review of key global, regional, or national ethical and regulatory documents, and previous expert consultations, this paper aims to summarise obstacles and suggest opportunities for appropriate inclusion of pregnant and lactating women in clinical trials. The authors conclude that a paradigm shift towards more inclusive and integrated research methodologies is urgently needed. This shift extends beyond pregnancy to transform the overall trial ecosystem and prioritise the health and wellbeing of all women and their infants everywhere, to truly achieve equitable access to health and innovations and leave no one behind.

Real-world data and real-world Evidence in regulatory decision making: report summary from the Council for International Organizations of Medical Sciences (CIOMS) Working Group XIII.

This study addresses these bioethical implications in the use of digital technologies to conduct mental health research, as noted by the Research Ethics Committee of the Ramón de la Fuente Muñiz National Institute of Psychiatry during the social distancing measures during the COVID-19 pandemic in Mexico. The increased use of digital tools abruptly transformed the manner in which studies were conducted, especially for those not familiar with this modality. The transition to these new digital technologies must include consideration of the bioethical implications of these strategies, and ethics committees must work with researchers to identify the best ways to safeguard the dignity, autonomy, and rights of participants.

The 8th European Pharmacovigilance Congress: speaker abstracts.

Aggregation of adverse event terms for signal detection and labeling in clinical trials. (Requires subscription). See also the CIOMS report on MedDRA Labeling Grouping (reference 40 in the publication)