Literature DB >> 22134525

EMA's reflection on placebo does not reflect patients' interests.

Vittorio Bertele'1, Rita Banzi, Christian Gluud, Silvio Garattini.   

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Year:  2011        PMID： 22134525     DOI： 10.1007/s00228-011-1175-4

Source DB:  PubMed          Journal:  Eur J Clin Pharmacol        ISSN： 0031-6970            Impact factor:   2.953


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  7 in total

1.  Efficacy, safety, and cost of new anticancer drugs.

Authors:  Silvio Garattini; Vittorio Bertele
Journal:  BMJ       Date:  2002-08-03

Review 2.  Disappointing biotech.

Authors:  Roberta Joppi; Vittorio Bertele'; Silvio Garattini
Journal:  BMJ       Date:  2005-10-15

3.  An update on the first decade of the European centralized procedure: how many innovative drugs?

Authors:  Domenico Motola; Fabrizio De Ponti; Elisabetta Poluzzi; Nello Martini; Pasqualino Rossi; Maria Chiara Silvani; Alberto Vaccheri; Nicola Montanaro
Journal:  Br J Clin Pharmacol       Date:  2006-06-23       Impact factor: 4.335

4.  CNS drugs approved by the centralised European procedure: true innovation or dangerous stagnation?

Authors:  Corrado Barbui; Andrea Cipriani; Camilla Lintas; Vittorio Bertelé; Silvio Garattini
Journal:  Psychopharmacology (Berl)       Date:  2006-11-22       Impact factor: 4.530

5.  Non-inferiority trials are unethical because they disregard patients' interests.

Authors:  Silvio Garattini; Vittorio Bertele'
Journal:  Lancet       Date:  2007-10-23       Impact factor: 79.321

6.  Human subject protection; foreign clinical studies not conducted under an investigational new drug application. Final rule.

Authors: 
Journal:  Fed Regist       Date:  2008-04-28

Review 7.  Placebo interventions for all clinical conditions.

Authors:  Asbjørn Hróbjartsson; Peter C Gøtzsche
Journal:  Cochrane Database Syst Rev       Date:  2010-01-20
  7 in total
  3 in total

Review 1.  Drug development: how academia, industry and authorities interact.

Authors:  Silvio Garattini; Norberto Perico
Journal:  Nat Rev Nephrol       Date:  2014-08-05       Impact factor: 28.314

2.  Recent controversies on comparative effectiveness research investigations: Challenges, opportunities, and pitfalls.

Authors:  Haresh Kirpalani; William E Truog; Carl T D'Angio; Michael Cotten
Journal:  Semin Perinatol       Date:  2016-08-08       Impact factor: 3.300

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

Authors:  Corrado Barbui; Irene Bighelli
Journal:  PLoS Med       Date:  2013-10-15       Impact factor: 11.069
  3 in total

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