o Organizations and essential documents
Ottawa Statement on trial registration.
- Krleža-Jeric K, Chan A-W, Dickersin K, Sim I, Grimshaw J, Gluud C for the Ottawa Group. The Ottawa Statement, Part One: Principles for international registration of protocol information and results from human trials of health-related interventions.
- Krleža-Jeric K. The Ottawa Statement, Part Two: Principles of operationalisation for international trial registration.
- Part 3 about Principles of implementation of registration and results disclosure is under elaboration.
The International Committee of Medical Journal Editors (ICMJE).
- Uniform Requirements for Manuscripts Submitted to Biomedical Journals: Publishing and Editorial Issues Related to Publication in Biomedical Journals: Obligation to Register Clinical Trials
- Update on FDAAA from ClinicalTrials.gov: Basic Results Reporting at ClinicalTrials.gov and “Prior Publication” (2008)
- Clinical Trial Registration: Looking Back and Moving Ahead (2007)
- Update on Trials Registration. Is This Clinical Trial Fully Registered?: A Statement from the International Committee of Medical Journal Editors (2005)
- Update on Trials Registration (2004)
- Clinical Trial Registration: A Statement from the International Committee of Medical Journal Editors (2004)
International Clinical Trial Registry Plataform (ICTRP) of WHO
o Recommended articles
- Krleža-Jeric K, Chan AW, Dickersin K, Sim I, Grimshaw J, Gluud C, en nombre del grupo de Ottawa. Principios del registro internacional de protocolos y resultados de ensayos clínicos a base de intervenciones de salud en seres humanos: Declaración de Ottawa (parte 1). Rev Panam Salud Pública/Pan Am J Public Health 19(6), 2006: 413-6
- Cuervo LG, Valdés A, Clark ML. El registro internacional de ensayos clínicos (editorial). Rev Panam Salud Pública/Pan Am J Public Health 2006; 19(6):365-70
o Hot topics
- Zarin DA, Tse T, Williams RJ, Califf RM, Ide NC. The ClinicalTrials.gov results database--update and key issues. N Engl J Med 2011;364(9):852-60.
- Krleža-Jeriç K, Lemmens T, Reveiz L, Cuervo LG, Bero LA. Prospective registration and results disclosure of clinical trials in the Americas: a roadmap toward transparency. Rev Panam Salud Pública. 2011 Jul;30(1):87-96.
- Viergever RF, Ghersi D. The quality of registration of clinical trials. PLoS One. 2011 Feb 24;6(2):e14701.
- Joint Position on the Disclosure of Clinical Trial Information via Clinical Trial Registries and Databases (2010)
- Bian ZX, Wu TX. Legislation for trial registration and data transparency. Trials. 2010 May 26;11:64
- Tse T, Williams RJ, Zarin DA. Reporting “Basic Results” in ClinicalTrials.gov. Chest 2009;136(1): 295–303.
- Thomas KB, Tesch C. Clinical Trial Disclosure: The ongoing debate on public registers for clinical trials. The Journal of the European Medical Writers Association 2007;16(2).
Printer-friendly version
PDF version