Literature DB >> 16513690

Harmful impact of EU clinical trials directive.

Akseli Hemminki, Pirkko-Liisa Kellokumpu-Lehtinen.   

Abstract

Mesh:

Year:  2006        PMID: 16513690      PMCID: PMC1388117          DOI: 10.1136/bmj.332.7540.501

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


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  6 in total

1.  American Society of Clinical Oncology guideline recommendations for sentinel lymph node biopsy in early-stage breast cancer.

Authors:  Gary H Lyman; Armando E Giuliano; Mark R Somerfield; Al B Benson; Diane C Bodurka; Harold J Burstein; Alistair J Cochran; Hiram S Cody; Stephen B Edge; Sharon Galper; James A Hayman; Theodore Y Kim; Cheryl L Perkins; Donald A Podoloff; Visa Haran Sivasubramaniam; Roderick R Turner; Richard Wahl; Donald L Weaver; Antonio C Wolff; Eric P Winer
Journal:  J Clin Oncol       Date:  2005-09-12       Impact factor: 44.544

2.  Directive 2001/20/EC of the European Parliament and of the Council of 4 April 2001 on the approximation of the laws, regulations and administrative provisions of the member states relating to the implementation of good clinical practice in the conduct of clinical trials on medicinal products for human use.

Authors: 
Journal:  Med Etika Bioet       Date:  2002 Spring-Summer

3.  Trastuzumab in the treatment of breast cancer.

Authors:  Gabriel N Hortobagyi
Journal:  N Engl J Med       Date:  2005-10-20       Impact factor: 91.245

4.  Effects of chemotherapy and hormonal therapy for early breast cancer on recurrence and 15-year survival: an overview of the randomised trials.

Authors: 
Journal:  Lancet       Date:  2005 May 14-20       Impact factor: 79.321

5.  Effects of radiotherapy and surgery in early breast cancer. An overview of the randomized trials.

Authors: 
Journal:  N Engl J Med       Date:  1995-11-30       Impact factor: 91.245

6.  Pooled analysis of fluorouracil-based adjuvant therapy for stage II and III colon cancer: who benefits and by how much?

Authors:  Sharlene Gill; Charles L Loprinzi; Daniel J Sargent; Stephan D Thomé; Steven R Alberts; Daniel G Haller; Jacqueline Benedetti; Guido Francini; Lois E Shepherd; Jean Francois Seitz; Roberto Labianca; Wei Chen; Stephen S Cha; Michael P Heldebrant; Richard M Goldberg
Journal:  J Clin Oncol       Date:  2004-04-05       Impact factor: 44.544

  6 in total
  34 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.  Are we keeping research participants safe enough?

Authors:  Paul C Hébert; Dean A Fergusson
Journal:  CMAJ       Date:  2010-04-26       Impact factor: 8.262

3.  Clinical research in Italy in adult patients unable to consent: after implementation of the European Union's Directive 2001/20/CE.

Authors:  Christian J Wiedermann; Mauro Almici; Salvatore Mangione; Antonello Giarratano; Oswald Mayr
Journal:  Intensive Care Med       Date:  2006-11-30       Impact factor: 17.440

4.  A model clinical trials agreement.

Authors:  Michael D E Goodyear
Journal:  BMJ       Date:  2006-11-17

5.  Clinical trials in emergency situations.

Authors:  Haleema Shakur; Ian Roberts; Lin Barnetson; Tim Coats
Journal:  BMJ       Date:  2007-01-27

6.  Effect of European Clinical Trials Directive on academic drug trials in Denmark: retrospective study of applications to the Danish Medicines Agency 1993-2006.

Authors:  Louise Berendt; Cecilia Håkansson; Karin Friis Bach; Kim Dalhoff; Per Buch Andreasen; Lene Grejs Petersen; Elin Andersen; Henrik Enghusen Poulsen
Journal:  BMJ       Date:  2007-12-06

Review 7.  Clinical trials in paediatric haematology-oncology: are future successes threatened by the EU directive on the conduct of clinical trials?

Authors:  Chris Mitchell
Journal:  Arch Dis Child       Date:  2007-11       Impact factor: 3.791

8.  Harmful impact of EU clinical trials directive: ...while paediatric oncology is being scuppered.

Authors:  Christopher D Mitchell
Journal:  BMJ       Date:  2006-03-18

9.  Harmful impact of EU clinical trials directive: ...and so has trial of melatonin in cancer related weight loss...

Authors:  Max Watson
Journal:  BMJ       Date:  2006-03-18

10.  Harmful impact of EU clinical trials directive: trial of alerting drug in fibromyalgia has had to be abandoned...

Authors:  Christopher D Hanning; Patricia Rentowl
Journal:  BMJ       Date:  2006-03-18
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