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Clinical Trial Documents, Videos, and Resources
| Clinical Trials Documents, Videos, and Resources |
As a service to researchers and health professionals, we continuously evaluate the available information on Clinical Trial and select and present the ones we consider more relevant.
Last Updated on Wednesday, 07 March 2012 09:08
Documents
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- WHO - The Mexico Statement on Health Research
- WHO - 58th Meeting of The World Health Assembly
- The Influence of the Pharmaceutical Industry
- Registering Clinical Trials: An Essential Role for WHO
Evans T, Gülmezoglu M, Pang T. Registering Clinical Trials: An Essential Role for WHO. The Lancet, 2004. 363:1413-1414
- Registering CIHR-funded randomized controlled trials: a global public good
- WHO Facilitates International Collaboration in Setting Standards for Clinical Trial Registration
Gülmezoglu M, Pang T, Horton R, Dickersin K. WHO Facilitates International Collaboration in Setting Standards for Clinical Trial Registration. The Lancet, 2005. 365:1829-1831
- Is This Clinical Trial Fully Registered?: A Statement From the International Committee of Medical Journal Editors
Catherine D. DeAngelis; Jeffrey M. Drazen; Frank A. Frizelle; Charlotte Haug; John Hoey Richard Horton; Sheldon Kotzin; Christine Laine; Ana Marusic; A. John P. M. Overbeke; Torben V. Schroeder; Harold C. Sox; Martin B. Van Der Weyden JAMA published 23 May 2005, 10.1001/jama.293.23.jed50037
- Fair Access to Clinical Trials
United States of America. 109th Congress Bill S. 470: Fair Access to Clinical Trials Act of 2005.
- Clinical trial registration
Reveiz L, Cardona AF, Ospina Clinical trial registration. N Engl J Med. 2005;352(2):198-9.
- WHO clinical trials initiative to protect the public
WHO clinical trials initiative to protect the public. Bulletin of the WHO - Volume 84, Number 1, January 2006.
- Options For Improving Public Access To Information On Clinical Trials Of Health Products In Canada.
Health Canada: External Working Group On The Registration And Disclosure Of Clinical Trial Information (EWG-CT).Options For Improving Public Access To Information On Clinical Trials Of Health Products In Canada. Dec 2006.
- Latin American Ongoing Clinical Trial Register (LATINREC) (Only available in Spanish)
Reveiz L, Delgado MB, Urrutia G, Ortiz Z, Garcia Dieguez M, Martí-Carvajal A, Calgua E, Vieyra A, Ciapponi A, Hidalgo R, Pantoja T, Sanchez LM, Martínez Pecino F, Tristan M. Latin American Ongoing Clinical Trial Register (LATINREC). Rev Panam Salud Publica. 2006;19(6):417-422
- El registro internacional de ensayos clínicos (only available in Spanish)
PAHO’s position paper (including Pan American Journal of Public Health) on trial registration: Cuervo LG, Valdés A, Clark ML. El registro internacional de ensayos clínicos [The International Clinical Trial Registry]. Rev Panam Salud Publica. 2006;19(6):365-370.
- Clinical trial registration: transparency is the watchword
Ida Sim, An-Wen Chan, A Metin Gülmezoglu, Tim Evans and Tikki Pang: Clinical trial registration: transparency is the watchword. The Lancet 2006; 367:1631-1633
- Title VIII - Clinical Trial Databases
United States of America. Food and Drug Administration Amendments Act of 2007. Title VIII - Clinical Trial Databases, p82-140, 27 Sep 2007.
- Registration of clinical trials: the international discussion and the possible positions to be taken by Brazil (only in Portuguese)
Jose da Rocha Carvalheiro, Cristiane Quental. Registration of clinical trials: the international discussion and the possible positions to be taken by Brazil. RECIIS, Vol 1, No 1 (2007), DOI: 10.3395/reciis.v1i1.42en>
- New standards for registration of human medical research
World Health Organization (2006) World Health Organization International Clinical Trials Registry Platform. New standards for registration of human medical research.
- Issues in the Registration of Clinical Trials
Zarin DA, Ide NC, Tse T, Harlan WL, West JC, Lindberg DAB. Issues in the Registration of Clinical Trials. JAMA. 2007; 297:2112-2120.
- Do trialists endorse clinical trial registration?
Reveiz L, Krleža-Jeric K, Chan A-W, De Aguiar S. Do trialists endorse clinical trial registration? Survey of a Pubmed sample. Trials. 2007 Oct 23;8:30.
- Clinical Trials Register Platform for Latin America and the Caribbean (238.75 KB) BIREME/PAHO/WHO. Sao Paulo: 2007
This report is still a preliminary vision for a Clinical Trial Register Platform for LAC. However, it collects and presents valuable information to accomplish the task and foster further discussion and more detailed specifications. Future versions of this document will give further information about lacking details such as data preparation and how the search and retrieval engine is supposed to work.
- Clinical Trial Registration: Looking Back and Moving Ahead
Laine C, Horton R, DeAngelis CD, Drazen JM, Frizelle FA, Godlee F, Haug C, Hébert PC, Kotzin S, Marusic A, Sahni P, Schroeder TV, Sox HC, Van Der Weyden MB, Verheugt FW. Clinical Trial Registration: Looking Back and Moving Ahead. Ann Intern Med. 2007 Aug 21;147(4):275-7.
- Minutes and Recommendations. Clinical Trial Registration in Latin America and the Caribbean Cochrane (856.07 kB) Cochrane Colloquium, October 26th, 2007. São Paulo, Brazil
The participants discussed about the progress and activities carried out to promote clinical trials registration in Latin American and the Caribbean. Presentations were also made on a framework for a Primary Clinical Trials Register Model built on an “open source” software and the methodology to collect and disseminate information on clinical trials and feed the ICTRP.
- Reporting the findings of clinical trials: a discussion paper. Bulletin of the World Health Organisation
Ghersi D, Clarke M, Berlin J, Gulmezoglu M, Kush R, Lumbiganon P, Moher D, Rockhold F, Sim I & Wager E. Reporting the findings of clinical trials: a discussion paper. Bulletin of the World Health Organisation. 2008; 86(6).
- Publication of Clinical Trials Supporting Successful New Drug Applications: A Literature Analysis
Lee K, Bacchetti P, Sim I. Publication of Clinical Trials Supporting Successful New Drug Applications: A Literature Analysis. PLoS Med. 2008 Sep 23;5(9):e191.
- Moving toward transparency of clinical trials
Zarin DA, Tse T. Medicine. Moving toward transparency of clinical trials. Science. 2008 Mar 7;319(5868):1340-2.
- International dialogue on the Public Reporting Of Clinical Trial Outcome and Results - PROCTOR meeting
Krleža-Jeric K. International dialogue on the Public Reporting Of Clinical Trial Outcome and Results - PROCTOR meeting. Croat Med J. 2008 Apr;49(2):267-8.
- En route to international clinical trial transparency
Ghersi D, Pang T. En route to international clinical trial transparency. The Lancet. 2008; 372:1531-1532.
- Clinical trials in India: ethical concerns
Clinical trials in India: ethical concerns. Bulletin of the World Health Organization. Volume 86, Number 8, August 2008, 577-656
- Trial Publication after Registration in ClinicalTrials.Gov: A Cross-Sectional Analysis
Ross JS, Mulvey GK, Hines EM, Nissen SE, Krumholz HM (2009) Trial Publication after Registration in Clinical Trials.Gov: A Cross-Sectional Analysis.
- Revision of the Declaration of Helsinki: Good News for the Transparency of Clinical Trials
Krleza-Jeric K, Lemmens T. 7th Revision of the Declaration of Helsinki: Good News for the Transparency of Clinical Trials. Croat Med J. 2009; 50: 105-10.
- From Mexico to Mali: four years in the history of clinical trial registration
Ghersi D, Pang T. From Mexico to Mali: four years in the history of clinical trial registration. Journal of Evidence-Based Medicine.
- Clinical trials registry advances in Latin America and the Caribbean
Clinical trials registry advances in Latin America and the Caribbean. Newsletter VHL 086 21/January/2009
- Strengthening the credibility of clinical research. The Lancet, 2010
- Reporting of methodologic information on trial registries for quality assessment: a study of trial records retrieved from the WHO search portal
Reveiz L, Chan AW, Krleza-Jerić K, Granados CE, Pinart M, Etxeandia I, Rada D, Martinez M, Bonfill X, Cardona AF. Reporting of methodologic information on trial registries for quality assessment: a study of trial records retrieved from the WHO search portal. PLoS One. 2010 Aug 31;5(8):e12484.
- Influence of trial registration on reporting quality of randomized trials: study from highest ranked journals
Reveiz L, Cortés-Jofré M, Asenjo Lobos C, Nicita G, Ciapponi A, Garcìa-Dieguez M, et al. Influence of trial registration on reporting quality of randomized trials: study from highest ranked journals. J Clin Epidemiol. 2010 Nov;63(11):1216-22
- The Quality of Registration of Clinical Trials
Viergever RF, Ghersi D (2011) The Quality of Registration of Clinical Trials. PLoS ONE 6(2): e14701. doi:10.1371/journal.pone.0014701
- Prospective registration and results disclosure of clinical trials in the Americas: a roadmap toward transparency
Krleza-Jeric 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 Publica. 2011;30(1):87-96.
- Progress and Challenges of Clinical Trials Registration in Latin America and the Caribean's (only in Spanish)
- Progress and Challenges of Clinical Trials Registration in Latin America and the Caribbean (only in Spanish)
Reveiz L, Saenz C, Murasaki RT, Cuervo LG, Ramalho L. Avances y retos en el registro de ensayos clínicos en América Latina y el Caribe [Progress and Challenges of Clinical Trials Registration in Latin America and the Caribbean]. Rev Peru Med Exp Salud Publica. 2011;28(4):676-81.
- Informed consent Elements
Department of Health and human services. Food and Drug Administration. Informed consent Elements 21 CRF part 50; Federal Register 2011;76(2)/ Rules and Regulations.
- Implementación de la iniciativa de registro de ensayos clínicos (only in Spanish)
Reveiz L, Cuervo LG. Implementación de la iniciativa de registro de ensayos clínicos. Revista Colombiana de Anestesiologia 2011;39(162): 21-26
- Clinical trial regulation in Argentina: overview and analysis of regulatory framework, use of existing tools, and researchers’ perspectives to identify potential barriers
White L, Ortiz Z, Cuervo LG, Reveiz L. Clinical trial regulation in Argentina: overview and analysis of regulatory framework, use of existing tools, and researchers’ perspectives to identify potential barriers. Rev Panam Salud Publica. 2011;30(5):445–52.
- WHO - The Mexico Statement on Health Research
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