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Literature DB >> 21613341

EMA must improve the quality of its clinical trial reports.

Corrado Barbui¹, Cinzia Baschirotto, Andrea Cipriani.

Abstract

Mesh：

Year: 2011 PMID： 21613341 DOI： 10.1136/bmj.d2291

Source DB: PubMed Journal: BMJ ISSN： 0959-8138

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12 in total

1. Optimizing investigator-led oncology research in Europe.

Authors: Tiziano Barbui; Magnus Björkholm; Alois Gratwohl
Journal: Haematologica Date: 2012-06 Impact factor: 9.941

2. Discrepancies in listed adverse drug reactions in pharmaceutical product information supplied by the regulatory authorities in Denmark and the USA.

Authors: Robert Eriksson; Lise Aagaard; Lars Juhl Jensen; Liza Borisova; Dorte Hørlück; Søren Brunak; Ebba Holme Hansen
Journal: Pharmacol Res Perspect Date: 2014-04-22

Review 3. Can systematic reviews contribute to regulatory decisions?

Authors: Corrado Barbui; Antonio Addis; Laura Amato; Giuseppe Traversa; Silvio Garattini
Journal: Eur J Clin Pharmacol Date: 2017-01-07 Impact factor: 2.953

4. Forty-five years of schizophrenia trials in Italy: a survey.

Authors: Marianna Purgato; Clive Adams; Corrado Barbui
Journal: Trials Date: 2012-04-12 Impact factor: 2.279

5. Information on new drugs at market entry: retrospective analysis of health technology assessment reports versus regulatory reports, journal publications, and registry reports.

Authors: Michael Köhler; Susanne Haag; Katharina Biester; Anne Catharina Brockhaus; Natalie McGauran; Ulrich Grouven; Heike Kölsch; Ulrike Seay; Helmut Hörn; Gregor Moritz; Kerstin Staeck; Beate Wieseler
Journal: BMJ Date: 2015-02-26

EMA must improve the quality of its clinical trial reports.

1. Optimizing investigator-led oncology research in Europe.

2. Discrepancies in listed adverse drug reactions in pharmaceutical product information supplied by the regulatory authorities in Denmark and the USA.

Review 3. Can systematic reviews contribute to regulatory decisions?

4. Forty-five years of schizophrenia trials in Italy: a survey.

5. Information on new drugs at market entry: retrospective analysis of health technology assessment reports versus regulatory reports, journal publications, and registry reports.

6. Why are there deadly drugs?

7. Quality and quantity of information in summary basis of decision documents issued by health Canada.

8. An update on the clinical evidence that supports biosimilar approvals in Europe.

9. A new approach to psychiatric drug approval in Europe.

10. Precaution, governance and the failure of medical implants: the ASR((TM)) hip in the UK.