EMA: Reflection Paper on the Use of Patient Reported Outcome (PRO) Measures in Oncology Studies (01-SEP-2014)

The importance of the patient’s point of view on their health status is fully acknowledged and such information may in principle be used in drawing regulatory conclusions regarding treatment effects. This reflection paper on the use of patient reported outcome (PRO) measures in patients with malignancies focuses on the value of these data from a […]

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Italy: New Platform for the “National Observatory on Clinical Trials of Medicines” (OsSC)(1-SEP-2014)

The National Monitoring Centre on Clinical Research with Medicines [Acknowledgements: Prof David Hutchinson. Principal Author & Editor of Advisor] [NOTE - The following does NOT apply to observational studies] The National Monitoring Centre on Clinical Research with Medicines (Osservatorio Nazionale sulla Sperimentazione Clinica con i Medicinali; OsSC) monitors ongoing clinical trials in Italy.  The Italian […]

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UK: NRES Website Closing Soon (14 Aug 2014)

The website of the National Research Ethics Service (NRES) site will be closing in a few weeks. The only areas that are maintained are the directory of Research Ethics Committees and the Research Summaries. The information previously found on the NRES website can now be found on the website of the Health Research Authority (HRA). […]

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UK: NHS REC Booking & Submission Changes (14 Aug 2014)

NHS REC Booking & Submission Changes – Implemented 19 May 2014 The HRA has changed the processes for applying to Research Ethics Committees (RECs) to improve its service and make the booking and application process more straightforward for researchers. The key changes that have been introduced are as follows: NEW Central Booking Service (CBS) for […]

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EU: Revision 3 of the ENCePP Guide on Methodological Standards in Pharmacoepidemiology Published (14 July 2014)

The Guide on Methodological Standards in Pharmacoepidemiology offers a single web resource for methodological English language guidance in pharmacoepidemiology. For each topic covered, direct electronic access is given to internationally agreed recommendations, and key points from important guidelines, published articles and textbooks are highlighted. Where relevant, gaps in existing guidance are addressed with what ENCePP […]

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