Literature DB >> 12660062

Role of a research ethics committee in follow-up and publication of results.

Judit Pich1, Xavier Carné, Joan-Albert Arnaiz, Begoña Gómez, Antoni Trilla, Juan Rodés.   

Abstract

Follow-up of clinical trials is a commitment rarely fulfilled by research ethics committees (RECs). We assessed the output of clinical trials submitted in 1997 to our REC, and talked to principal investigators, sponsors, contract research organisations, or a combination of these. During 1997, our REC reviewed 166 clinical trials, and approved 158. The recruitment rate was lower than expected in 45% (64/143) of all initiated clinical trials; 64% (92/143) were finished in accordance with protocol. 3 years after, the results of only 21% (26/123) of finished clinical trials were published in peer-reviewed journals, rising to 31% (38/123) if in-press articles were included. RECs should devote more effort and resources to assess public dissemination of results of clinical trials.

Keywords:  Biomedical and Behavioral Research; Empirical Approach

Mesh:

Year:  2003        PMID: 12660062     DOI: 10.1016/S0140-6736(03)12799-7

Source DB:  PubMed          Journal:  Lancet        ISSN: 0140-6736            Impact factor:   79.321


  32 in total

1.  [Psychiatrists and the pharmaceutical industry].

Authors:  H Helmchen
Journal:  Nervenarzt       Date:  2003-11       Impact factor: 1.214

2.  Are results from pharmaceutical-company-sponsored studies available to the public?

Authors:  Rafael Dal-Ré; Alejandro Pedromingo; Manuel García-Losa; Juan Lahuerta; Rafael Ortega
Journal:  Eur J Clin Pharmacol       Date:  2010-09-16       Impact factor: 2.953

3.  Methodological characteristics of academic clinical drug trials--a retrospective cohort study of applications to the Danish Medicines Agency 1993-2005.

Authors:  Louise Berendt; Cecilia Håkansson; Karin F Bach; Per B Andreasen; Lene G Petersen; Elin Andersen; Henrik E Poulsen; Kim Dalhoff
Journal:  Br J Clin Pharmacol       Date:  2010-11       Impact factor: 4.335

4.  Multicentre trials review process by research ethics committees in Spain: where do they stand before implementing the new European regulation?

Authors:  R Dal-Ré; R Ortega; E Morejón
Journal:  J Med Ethics       Date:  2005-06       Impact factor: 2.903

5.  Fate of biomedical research protocols and publication bias in France: retrospective cohort study.

Authors:  Evelyne Decullier; Véronique Lhéritier; François Chapuis
Journal:  BMJ       Date:  2005-06-20

Review 6.  Publication bias in clinical trials due to statistical significance or direction of trial results.

Authors:  Sally Hopewell; Kirsty Loudon; Mike J Clarke; Andrew D Oxman; Kay Dickersin
Journal:  Cochrane Database Syst Rev       Date:  2009-01-21

7.  SPIRIT 2013 explanation and elaboration: guidance for protocols of clinical trials.

Authors:  An-Wen Chan; Jennifer M Tetzlaff; Peter C Gøtzsche; Douglas G Altman; Howard Mann; Jesse A Berlin; Kay Dickersin; Asbjørn Hróbjartsson; Kenneth F Schulz; Wendy R Parulekar; Karmela Krleza-Jeric; Andreas Laupacis; David Moher
Journal:  BMJ       Date:  2013-01-08

Review 8.  Reporting bias in medical research - a narrative review.

Authors:  Natalie McGauran; Beate Wieseler; Julia Kreis; Yvonne-Beatrice Schüler; Heike Kölsch; Thomas Kaiser
Journal:  Trials       Date:  2010-04-13       Impact factor: 2.279

9.  Extent of publication bias in different categories of research cohorts: a meta-analysis of empirical studies.

Authors:  Fujian Song; Sheetal Parekh-Bhurke; Lee Hooper; Yoon K Loke; Jon J Ryder; Alex J Sutton; Caroline B Hing; Ian Harvey
Journal:  BMC Med Res Methodol       Date:  2009-11-26       Impact factor: 4.615

10.  Inadequate dissemination of phase I trials: a retrospective cohort study.

Authors:  Evelyne Decullier; An-Wen Chan; François Chapuis
Journal:  PLoS Med       Date:  2009-02-17       Impact factor: 11.069

View more

北京卡尤迪生物科技股份有限公司 © 2022-2023.