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

Clinical Trials Registry : A tool to strengthen access to ,andconfidence in ,clinical research

Gustavo Luiz F. Kesselring,MD

Page 2: Clinical Trials Registry : A tool to strengthen access to,and confidence in,clinical research Gustavo Luiz F. Kesselring,MD

Gustavo Luiz F.Kesselring, MD

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

Page 3: Clinical Trials Registry : A tool to strengthen access to,and confidence in,clinical research Gustavo Luiz F. Kesselring,MD

REVISTA ÉPOCA, 07 DE AGOSTO DE 2006REVISTA ÉPOCA, 07 DE AGOSTO DE 2006

Page 4: Clinical Trials Registry : A tool to strengthen access to,and confidence in,clinical research Gustavo Luiz F. Kesselring,MD

JAMA, Published online August 7, 2006

Reprinted) JAMA, Published online August 7, 2006

Page 5: Clinical Trials Registry : A tool to strengthen access to,and confidence in,clinical research Gustavo Luiz F. Kesselring,MD

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

Page 6: Clinical Trials Registry : A tool to strengthen access to,and confidence in,clinical research Gustavo Luiz F. Kesselring,MD

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.

Page 7: Clinical Trials Registry : A tool to strengthen access to,and confidence in,clinical research Gustavo Luiz F. Kesselring,MD

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.

Page 8: Clinical Trials Registry : A tool to strengthen access to,and confidence in,clinical research Gustavo Luiz F. Kesselring,MD

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

Page 9: Clinical Trials Registry : A tool to strengthen access to,and confidence in,clinical research Gustavo Luiz F. Kesselring,MD
Page 10: Clinical Trials Registry : A tool to strengthen access to,and confidence in,clinical research Gustavo Luiz F. Kesselring,MD

,

JAMA 2004 292:1363-1363

Page 11: Clinical Trials Registry : A tool to strengthen access to,and confidence in,clinical research Gustavo Luiz F. Kesselring,MD

International Standard Randomized Controlled Trial NumberISRCTN register

http://www.controlled-trials.com/isrctn/ 21/8/2006

Page 12: Clinical Trials Registry : A tool to strengthen access to,and confidence in,clinical research Gustavo Luiz F. Kesselring,MD

ClinicalTrials.govNational Library of Medicine

http://www.clinicaltrials.gov/ 21/8/2006

Page 13: Clinical Trials Registry : A tool to strengthen access to,and confidence in,clinical research Gustavo Luiz F. Kesselring,MD

www.ifpma.org/clinicaltrials September 2005

Page 14: Clinical Trials Registry : A tool to strengthen access to,and confidence in,clinical research Gustavo Luiz F. Kesselring,MD

July 2006 - The Secretariat of the Registry Platform, WHO,

Geneva, Switzerland

Page 15: Clinical Trials Registry : A tool to strengthen access to,and confidence in,clinical research Gustavo Luiz F. Kesselring,MD

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

Page 16: Clinical Trials Registry : A tool to strengthen access to,and confidence in,clinical research Gustavo Luiz F. Kesselring,MD

January 2005

Page 17: Clinical Trials Registry : A tool to strengthen access to,and confidence in,clinical research Gustavo Luiz F. Kesselring,MD

January 2005

Page 18: Clinical Trials Registry : A tool to strengthen access to,and confidence in,clinical research Gustavo Luiz F. Kesselring,MD

Clinical Trial Registration: The Differing Viewsof Industry, the WHO, and the Ottawa Group

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

Page 19: Clinical Trials Registry : A tool to strengthen access to,and confidence in,clinical research Gustavo Luiz F. Kesselring,MD

Clinical Trial Registration: The Differing Viewsof Industry, the WHO, and the Ottawa Group

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

Page 20: Clinical Trials Registry : A tool to strengthen access to,and confidence in,clinical research Gustavo Luiz F. Kesselring,MD

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 ?

.

Page 21: Clinical Trials Registry : A tool to strengthen access to,and confidence in,clinical research Gustavo Luiz F. Kesselring,MD

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