Author： Bhatti Susan
Publisher： Maney Publishing
ISSN： 2047-4814
Source： Medical Writing, Vol.22, Iss.2, 2013-06, pp. : 124-127
Disclaimer: Any content in publications that violate the sovereignty, the constitution or regulations of the PRC is not accepted or approved by CNPIEC.
Abstract
Access to patient data gathered in clinical trials is a highly controversial and complex issue that needs to balance three aspects: the public right to transparency regarding data used to approve new medicines, protection of the data privacy rights of patients involved in the studies, and commercial confidentiality concerns of the trial sponsors. In response to an increasing number of formal complaints about restrictive practices in publicising clinical data, the European Medicines Agency has started an initiative to enable access to patient-level study data. In November 2012, they organised a workshop to bring the stakeholders together to discuss and establish the way forward.
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