Clinical disclosures
All together now
Some of the world’s largest funders of medical research and international non-governmental organisations have agreed on new standards that will require all clinical trials they fund or support to be registered and the results disclosed publicly.
In a joint statement, the Indian Council of Medical Research, the Norwegian Research Council, the UK Medical Research Council, Médecins Sans Frontières and Epicentre (its research arm), PATH, the Coalition for Epidemic Preparedness Innovations (CEPI), Institut Pasteur, the Bill & Melinda Gates Foundation, and the Wellcome Trust have agreed to develop and implement policies within the next 12 months that require all trials they fund, co-fund, sponsor or support to be registered in a public registry.
Raising the bar
Improved adverse event reporting
The European Medicines Agency (EMA) will launch a new and improved version of EudraVigilance, the European information system of suspected adverse reactions to medicines that are authorised or being studied in clinical trials in the European Economic Area (EEA). The new version will go live on November 22, 2017 with enhanced functionalities for reporting and analysing suspected adverse reactions, the EMA said.
Psychosocial assessment
Adoloscents at risk
Adolescents who are admitted to hospital for alcohol, drug, or violence related injuries are at a similar risk of suicide 10 years later than those who have self-harmed, according to a study using data from one million adolescents in the United Kingdom and published in The Lancet .
The authors suggest that such adolescents should be treated with a similar response from mental health professionals to those who are admitted after self-harm.
Specialist psychosocial assessment by a child and adolescent mental health professional is recommended.
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