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Clinical Trials Registry : A tool to strengthen access to,and confidence in,clinical research Gustavo Luiz F. Kesselring,MD.

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Presentation on theme: "Clinical Trials Registry : A tool to strengthen access to,and confidence in,clinical research Gustavo Luiz F. Kesselring,MD."— Presentation transcript:

1 Clinical Trials Registry : A tool to strengthen access to,and confidence in,clinical research Gustavo Luiz F. Kesselring,MD

2 Disclosure President Brazilian Society Of Pharmaceutical Medicine Director Clinical Operations IBIC. Brazilian Clinical Research Center Current Clinical Investigator: Lilly ; Wyeth ; Stiefel ; Sanofi-Aventis Former Clinical Research Director Hoechst Marion Roussel

3 REVISTA ÉPOCA, 07 DE AGOSTO DE 2006

4 JAMA, Published online August 7, 2006 Reprinted) JAMA, Published online August 7, 2006

5 WHY MOST PUBLISHED RESEARCH FINDINGS ARE FALSE Ioannidis, J.P.S. PLoS MEDICINE Vo. 2, No. 8: August 2005 DOI-10.1371/journal.pmed.0020124 http://medicine.plosjournals.org

6 WHY MOST PUBLISHED RESEARCH FINDINGS ARE FALSE. Ioannidis, J.P.S. PLoS MEDICINE Vo. 2, No. 8: August 2005 DOI-10.1371/journal.pmed.0020124 http://medicine.plosjournals.org Corollary 5: The greater the financial and other interests and prejudices in a scientific field, the less likely the research findings are to be true Conflicts of interest and prejudice may increase bias, u. Conflicts of interest are very common in biomedical research, and typically they are inadequately and sparsely reported. Prejudice may not necessarily have financial roots. Scientists in a given field may be prejudiced purely because of their belief in a scientific theory or commitment to their own findings.

7 WHY MOST PUBLISHED RESEARCH FINDINGS ARE FALSE. Ioannidis, J.P.S. PLoS MEDICINE Vo. 2, No. 8: August 2005 DOI-10.1371/journal.pmed.0020124 http://medicine.plosjournals.org Corollary 5: The greater the financial and other interests and prejudices in a scientific field, the less likely the research findings are to be true Many otherwise seemingly independent, university-based studies may be conducted for no other reason than to give physicians and researchers qualifications for promotion or tenure. Such nonfinancial conflicts may also lead to distorted reported results and interpretations.

8 PLoS Medicine | www.plosmedicine.org November 2005 | Volume 2 | Issue 11 | e378

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10 , JAMA 2004 292:1363-1363

11 International Standard Randomized Controlled Trial Number ISRCTN register http://www.controlled-trials.com/isrctn/http://www.controlled-trials.com/isrctn/ 21/8/2006

12 ClinicalTrials.gov National Library of Medicine http://www.clinicaltrials.gov/http://www.clinicaltrials.gov/ 21/8/2006

13 www.ifpma.org/clinicaltrialswww.ifpma.org/clinicaltrials September 2005

14 July 2006 - The Secretariat of the Registry Platform, WHO, Geneva, Switzerland

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16 January 2005

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18 Clinical Trial Registration: The Differing Views of Industry, the WHO, and the Ottawa Group www.plosmedicine.orgwww.plosmedicine.org November 2005 | Volume 2 | Issue 11 | e378

19 Clinical Trial Registration: The Differing Views of Industry, the WHO, and the Ottawa Group www.plosmedicine.orgwww.plosmedicine.org November 2005 | Volume 2 | Issue 11 | e378

20 Clinical Trials Registry : A tool to strengthen access to,and confidence in,clinical research FUTURE? Unique ? Multiple? WHO? Clinicaltrials.gov ? Controlled-trials.com/isrctn ? Ifpma.org/clinicaltrials ? Ottawa group ? Others ?.

21 PLoS Medicine | www.plosmedicine.org November 2005 | Volume 2 | Issue 11 | e378

22 OBRIGADO ! kesselring@uol.com.br www.sbmf.org.br


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