Medical Writing Medical Writing Around the World Report on the EMA Workshop on clinical trial data and transparency

Volume 22, Issue 2 - Medical Writing Around the World

Report on the EMA Workshop on clinical trial data and transparency

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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References

  1. TRIPs Agreement: Agreement on Trade-Related Aspects of Intellectual Property Rights. The TRIPS Agreement is Annex 1C of the Marrakesh Agreement Establishing the World Trade Organization, signed in Marrakesh, Morocco on 15 April 1994. Available from: http://www.wto.org/

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Medical writing around the world
Message from the President
The yin and yang of medical writing in China
The changing face of medical writing in India
Medical writing in India at a crossroads
Medical writing in the Middle East
Medical writing in Finland
On the western edge of Europe – medical writing in Portugal
Announcing AERTeM, the Spanish Association of Medical Writers
From editors abroad into businesswomen back in Brazil
Science writing workshops for AIDS vaccine researchers in Africa
Medical postcard from Australia, the world's largest island
Teaching English for Medical Academic Purposes at the Faculty of Medicine in Belgrade, Serbia
Regulatory medical writing in Switzerland
Medical writing in the Russian Federation: Promises and pitfalls
Report on the EMA Workshop on clinical trial data and transparency
Potential implications of wider data transparency in medical communications
The need for registration of preclinical studies
Mentorship in EMWA: A perspective
In the Bookstores
The Webscout
Regulatory Writing
English Grammar and Style
Medical Journalism
Medical Communication
The Light Stuff
Out On Our Own

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