BMJ  2004;329:637-638 (18 September), doi:10.1136/bmj.329.7467.637

Editorial

Compulsory registration of clinical trials

Will be a requirement before submission to the BMJ from July 2005

The first 150 words of the full text of this article appear below.

"The case for registering all clinical trials—first advanced a decade ago1—is now unanswerable."2 Editors of the BMJ and the Lancet made this statement in 1999. Five years of industry resistance, government impotence, and public confusion followed. Medical journals persisted with noble intentions and wise words but were themselves in part resistant, impotent, and confused about how to enforce registration. Some journals, including the BMJ, tried an amnesty for unpublished trials, with little success.3 The BMJ also considered asking for compulsory registration, but it seemed to us that trial registries were too diverse, disorganised, and easily disregarded to insist on registration before submission. Nor did we want fees for registering trials to be a barrier to researchers wanting to publish in the BMJ.

The world has changed. Undisclosed trials and duplicate and selective publication sting government agencies, clinicians, researchers, and journals ever more frequently and painfully. . . . [Full text of this article]

Kamran Abbasi, acting editor BMJ


Add to CiteULike CiteULike   Add to Complore Complore   Add to Connotea Connotea   Add to Del.icio.us Del.icio.us   Add to Digg Digg   Add to Reddit Reddit   Add to Technorati Technorati    What's this?

Related Articles

Fate of biomedical research protocols and publication bias in France: retrospective cohort study
Evelyne Decullier, Véronique Lhéritier, and François Chapuis
BMJ 2005 331: 19. [Abstract] [Full Text] [PDF]

Next steps in trial registration
Kamran Abbasi and Fiona Godlee
BMJ 2005 330: 1222-1223. [Extract] [Full Text] [PDF]

Principles for international registration of protocol information and results from human trials of health related interventions: Ottawa statement (part 1)
Karmela Krleza-Jeric, An-Wen Chan, Kay Dickersin, Ida Sim, Jeremy Grimshaw, Christian Gluud for the Ottawa Group
BMJ 2005 330: 956-958. [Extract] [Full Text] [PDF]

More on compulsory registration of clinical trials: GSK has created useful register
Ronald Krall and Frank Rockhold
BMJ 2005 330: 479-480. [Extract] [Full Text]

More on compulsory registration of clinical trials: Complete clinical trial register is already reality for paediatrics
M Bonati, C Pandolfini DEC-net collaborative group
BMJ 2005 330: 480. [Extract] [Full Text]

Compulsory registration of clinical trials: Publicly funded national register of trials would be best in the United Kingdom
Lesley Stewart, Claire Vale, and Janet Darbyshire
BMJ 2004 329: 1043-1044. [Extract] [Full Text]

Compulsory registration of clinical trials: Maybe European research should be protected
Ernst A Singer and Christiane Druml
BMJ 2004 329: 1044. [Extract] [Full Text]

Compulsory registration of clinical trials: Under-reporting is not an option
Peter Jay and Mike Wallace
BMJ 2004 329: 1044. [Extract] [Full Text]

This article has been cited by other articles:

  • Santoro, E., Rossi, V., Pandolfini, C., Bonati, M. (2006). DEC-net: the development of the European register of clinical trials on medicines for children. Clin Trials 3: 366-375 [Abstract]  
  • Sheard, L, Tompkins, C N E, Wright, N M J, Adams, C E (2006). Non-commercial clinical trials of a medicinal product: can they survive the current process of research approvals in the UK?. J. Med. Ethics 32: 430-434 [Abstract] [Full text]  
  • Gold, J. L., Studdert, D. M. (2005). Clinical Trials Registries: A Reform that is Past Due. J Law Med Ethics 33: 811-820  
  • Decullier, E., Lheritier, V., Chapuis, F. (2005). Fate of biomedical research protocols and publication bias in France: retrospective cohort study. BMJ 331: 19- [Abstract] [Full text]  
  • Sammons, H M, Naylor, C, Choonara, I, Pandolfini, C, Bonati, M (2005). Should paediatricians support the European Paediatric Clinical Trials Register?. Arch. Dis. Child. 90: 559-560 [Full text]  
  • Abbasi, K., Godlee, F. (2005). Next steps in trial registration. BMJ 330: 1222-1223 [Full text]  
  • Krleza-Jeric, K., Chan, A.-W., Dickersin, K., Sim, I., Grimshaw, J., Gluud, C., for the Ottawa Group, (2005). Principles for international registration of protocol information and results from human trials of health related interventions: Ottawa statement (part 1). BMJ 330: 956-958 [Full text]  
  • Bonati, M, Pandolfini, C, DEC-net collaborative group, (2005). More on compulsory registration of clinical trials: Complete clinical trial register is already reality for paediatrics. BMJ 330: 480-480 [Full text]  
  • Krall, R., Rockhold, F. (2005). More on compulsory registration of clinical trials: GSK has created useful register. BMJ 330: 479-480 [Full text]  
  • Abbasi, K. (2005). Trial results: the next battle. BMJ 330: - [Full text]  
  • Watts, R., Cubie, S. (2005). 'Onwards and Upwards'. Rheumatology (Oxford) 44: 1-2 [Full text]  
  • Jones, G., Abbasi, K. (2004). Trial protocols at the BMJ. BMJ 329: 1360-1360 [Full text]  
  • Singer, E. A, Druml, C. (2004). Compulsory registration of clinical trials: Maybe European research should be protected. BMJ 329: 1044-1044 [Full text]  
  • Stewart, L., Vale, C., Darbyshire, J. (2004). Compulsory registration of clinical trials: Publicly funded national register of trials would be best in the United Kingdom. BMJ 329: 1043-1044 [Full text]  
  • Jay, P., Wallace, M. (2004). Compulsory registration of clinical trials: Under-reporting is not an option. BMJ 329: 1044-1044 [Full text]  

Rapid Responses:

Read all Rapid Responses

Latinoamerican Ongoing Clinical Trials Register (LATINREC)
Ludovic Reveiz, et al.
bmj.com, 17 Sep 2004 [Full text]
ICMJE needs helping hands
Arun S Nanivadekar
bmj.com, 20 Sep 2004 [Full text]
The reality of trial registration in practice
Lesley A Stewart, et al.
bmj.com, 29 Sep 2004 [Full text]
DNR for European Academic Research?
Ernst A Singer, et al.
bmj.com, 1 Oct 2004 [Full text]
Under reporting of clinical trials
Mike Wallace, et al.
bmj.com, 4 Oct 2004 [Full text]
A complete clinical trial register is already a reality for the paediatric field
Maurizio Bonati, et al.
bmj.com, 23 Dec 2004 [Full text]
Clinical Trials Registers
Frank W Rockhold, et al.
bmj.com, 12 Jan 2005 [Full text]



Student BMJ

Intimate examinations

Israeli students are refusing to perform intimate examinations on anaesthetised women without their informed consent.

www.student.bmj.com

Listen to the latest BMJ Interview