News from working groups: Clinical Study Reports?

In June 2017 ISDB Committee members and other bulletins interested, participated in a workshop on clinical study reports (CSRs). This two day workshop was organized by the Institut für Qualität und Wirtschaftlichkeit im Gesundheitswesen (Institute for Quality and Efficiency in Health Care, IQWIG) in Cologne, Germany. Beate Wieseler and her colleagues lectured about the framework of these CSRs and we could also practice what we had learned. The participants were very enthusiastic about this experience and the Committee discussed how we could further develop our knowledge. Interestingly, the Cochrane Collaboration was also working on this topic and the Committee and interested members gave input to their proposal on the guidance for including CSR’s in their reviews. On the Cochrane Collaboration’s website the following information was shared (http://community.cochrane.org/ news/request-comments-draftinterim-guidance-how-decidewhether-incorporate-clinical-studyreports-and-other-regulatorydocuments-cochrane-reviews).

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News from working groups: Clinical Trials Group

Nuria Homedes  We have been working hard. Two years ago, we divided Bulletin Farmacos in four bulletins. Due to the large amount of information that is emerging and the interests of our Spanish readership, one of the bulletins has been dedicated to Ethics and Clinical trials. The other bulletins are devoted to Pharmacovigilance and Appropriate use, Access and Economics, Regulatory Agencies and Policies. Consequently, we have increased the number of translations into Spanish from English and French sources.

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No to EMA’s provision of confidential scientific advice to drug companies (November 2017)

Paris, 28 November 2017 Prescrire, along with around 20 civil society organisations, has signed a joint declaration drawing attention to potential problems posed by the provision of confidential scientific advice by the European Medicines Agency to pharmaceutical companies, especially a decline in regulatory standards, a risk of institutional capture, and a total lack of transparency surrounding the activity of European regulatory authorities.

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