On 22 November, the European Medicines Agency (EMA) held a workshop on access to clinical- trial data and transparency. A spokesperson said that the event marked the beginning of the move towards the proactive disclosure of clinical trial data., a decision was initially announced in April 2012 in ‘Open clinical trial data for all? A view from regulators.’
The EMA stated that access to data would allow stakeholders to analyse clinical trial data and aimed to reinforce trust and transparency. The EMA will establish policies in five different fields, formulated with the support and advice of stakeholders. These areas are patient confidentiality, clinical trial data formats, rules of engagement, good analysis practice and legal aspects.
More information, including the press release and original article can be accessed at:
Since our inception in 2006, UKRIO has stressed – through our advisory service, our education and training, and our publications – that all research should be conducted to the highest standards of honesty, accuracy, integrity and accountability. We have always been clear that organisations and researchers should promote the open exchange, discussion and scrutiny of ideas, research methods, data and results.
It is essential that research is honest and accurate. This is necessary to retain the public’s trust, to safeguard the wellbeing of research participants and patients, and to ensure that decisions are not based on biased or incomplete evidence. Making raw data available when research is published would increase transparency, and therefore trust in research. It would also make it harder for organisations to analyse results inappropriately. The more people who can scrutinise research, the better.