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1. Data Sharing Statements for Clinical Trials.

Author

Taichman DB, Sahni P, Pinborg A, Peiperl L, Laine C, James A, Hong ST, Haileamlak A, Gollogly L, Godlee F, Frizelle FA, Florenzano F, Drazen JM, Bauchner H, Baethge C, and Backus J

Subjects
Clinical Trials as Topic standards, Humans, International Cooperation, Societies, Medical, Clinical Trials as Topic organization & administration, Datasets as Topic standards, Editorial Policies, Information Dissemination, Periodicals as Topic standards
Published
2017
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2. Data Sharing Statements for Clinical Trials: A Requirement of the International Committee of Medical Journal Editors.

Author

Taichman DB, Sahni P, Pinborg A, Peiperl L, Laine C, James A, Hong ST, Haileamlak A, Gollogly L, Godlee F, Frizelle FA, Florenzano F, Drazen JM, Bauchner H, Baethge C, and Backus J

Subjects
Clinical Trials as Topic standards, Humans, International Cooperation, Societies, Medical, Clinical Trials as Topic organization & administration, Datasets as Topic standards, Editorial Policies, Information Dissemination, Periodicals as Topic standards
Published
2017
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3. Data Sharing Statements for Clinical Trials: A Requirement of the International Committee of Medical Journal Editors.

Author

Taichman DB, Sahni P, Pinborg A, Peiperl L, Laine C, James A, Hong ST, Haileamlak A, Gollogly L, Godlee F, Frizelle FA, Florenzano F, Drazen JM, Bauchner H, Baethge C, and Backus J

Subjects
Clinical Trials as Topic standards, Humans, International Cooperation, Societies, Medical, Clinical Trials as Topic organization & administration, Datasets as Topic standards, Editorial Policies, Information Dissemination, Periodicals as Topic standards
Published
2017
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4. Data sharing statements for clinical trials: a requirement of the International Committee of Medical Journal Editors.

Author

Taichman DB, Sahni P, Pinborg A, Peiperl L, Laine C, James A, Hong ST, Haileamlak A, Gollogly L, Godlee F, Frizelle FA, Florenzano F, Drazen JM, Bauchner H, Baethge C, and Backus J

Subjects
Editorial Policies, Humans, International Cooperation, Societies, Medical standards, Clinical Trials as Topic methods, Clinical Trials as Topic standards, Information Dissemination methods, Periodicals as Topic standards, Registries standards
Published
2017
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5. Data Sharing Statements for Clinical Trials: A Requirement of the International Committee of Medical Journal Editors.

Author

Taichman DB, Sahni P, Pinborg A, Peiperl L, Laine C, James A, Hong ST, Haileamlak A, Gollogly L, Godlee F, Frizelle FA, Florenzano F, Drazen JM, Bauchner H, Baethge C, and Backus J

Subjects
Clinical Trials as Topic standards, Humans, International Cooperation, Societies, Medical, Clinical Trials as Topic organization & administration, Datasets as Topic standards, Editorial Policies, Information Dissemination, Periodicals as Topic standards
Published
2017
Full Text
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6. Data sharing statements for clinical trials: a requirement of the International Committee of Medical Journal Editors.

Author

Taichman DB, Sahni P, Pinborg A, Peiperl L, Laine C, James A, Hong ST, Haileamlak A, Gollogly L, Godlee F, Frizelle FA, Florenzano F, Drazen JM, Bauchner H, Baethge C, and Backus J

Subjects
Clinical Trials as Topic standards, Humans, International Cooperation, Societies, Medical, Clinical Trials as Topic organization & administration, Datasets as Topic standards, Editorial Policies, Information Dissemination, Periodicals as Topic standards
Abstract

Competing Interests: Dr. Gollogly reports being employed by the World Health Organization. Dr. Haileamlak is an employee of Jimma University in Ethiopia and the Editor of EJHS. Dr. Laine reports that she is employed as an editor by the Annals of Internal Medicine and the American College of Physicians. Dr. Peiperl reports other from Public Library of Science, non-financial support from World Health Organization, non-financial support from Association of Healthcare Journalists, outside the submitted work. Dr. Taichman reports that he is employed as an editor by the Annals of Internal Medicine and the American College of Physicians.

Published
2017

7. [Data sharing statements for clinical trials: a requirement of the International Committee of Medical Journal Editors].

Author

Taichman DB, Sahni P, Pinborg A, Peiperl L, Laine C, James A, Hong ST, Haileamlak A, Gollogly L, Godlee F, Frizelle FA, Florenzano F, Drazen JM, Bauchner H, Baethge C, and Backus J

Subjects
Clinical Trials as Topic standards, Humans, International Cooperation, Societies, Medical, Clinical Trials as Topic organization & administration, Datasets as Topic standards, Editorial Policies, Information Dissemination, Periodicals as Topic standards
Published
2017

8. Data sharing statements for clinical trials: a requirement of the International Committee of Medical Journal Editors.

Author

Taichman DB, Sahni P, Pinborg A, Peiperl L, Laine C, James A, Hong ST, Haileamlak A, Gollogly L, Godlee F, Frizelle FA, Florenzano F, Drazen JM, Bauchner H, Baethge C, and Backus J

Subjects
Clinical Trials as Topic standards, Humans, International Cooperation, Societies, Medical, Clinical Trials as Topic organization & administration, Datasets as Topic standards, Editorial Policies, Information Dissemination, Periodicals as Topic standards
Published
2017
Full Text
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9. Data Sharing Statements for Clinical Trials - A Requirement of the International Committee of Medical Journal Editors.

Author

Taichman DB, Sahni P, Pinborg A, Peiperl L, Laine C, James A, Hong ST, Haileamlak A, Gollogly L, Godlee F, Frizelle FA, Florenzano F, Drazen JM, Bauchner H, Baethge C, and Backus J

Subjects
Clinical Trials as Topic standards, Humans, International Cooperation, Societies, Medical, Clinical Trials as Topic organization & administration, Datasets as Topic standards, Editorial Policies, Information Dissemination, Periodicals as Topic standards
Published
2017
Full Text
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10. Data sharing statements for clinical trials.

Author

Taichman DB, Sahni P, Pinborg A, Peiperl L, Laine C, James A, Hong ST, Haileamlak A, Gollogly L, Godlee F, Frizelle FA, Florenzano F, Drazen JM, Bauchner H, Baethge C, and Backus J

Subjects
Clinical Trials as Topic standards, Humans, International Cooperation, Periodicals as Topic, Societies, Medical, Clinical Trials as Topic organization & administration, Datasets as Topic standards, Editorial Policies, Information Dissemination
Abstract

Competing Interests: Competing interests: We have read and understood BMJ policy on declaration of interests and declare that LP has received travel reimbursement from the WHO and the Association of Health Care Journalists for consulting and speaking activities relating to data sharing.

Published
2017
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11. Data Sharing Statements for Clinical Trials: A Requirement of the International Committee of Medical Journal Editors.

Author

Taichman DB, Sahni P, Pinborg A, Peiperl L, Laine C, James A, Hong ST, Haileamlak A, Gollogly L, Godlee F, Frizelle FA, Florenzano F, Drazen JM, Bauchner H, Baethge C, and Backus J

Subjects
Clinical Trials as Topic standards, Humans, Societies, Medical, Clinical Trials as Topic organization & administration, Datasets as Topic standards, Editorial Policies, Information Dissemination, International Cooperation, Periodicals as Topic standards
Abstract

The International Committee of Medical Journal Editors announces requirements that a data sharing plan be prospectively registered, and a data sharing statement be included in submitted manuscripts, for clinical trials to be published in ICMJE journals.

Published
2017
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12. Data Sharing Statements for Clinical Trials: A Requirement of the International Committee of Medical Journal Editors.

Author

Taichman DB, Sahni P, Pinborg A, Peiperl L, Laine C, James A, Hong ST, Haileamlak A, Gollogly L, Godlee F, Frizelle F, Florenzano F, Drazen JM, Bauchner H, Baethge C, and Backus J

Subjects
Clinical Trials as Topic standards, Humans, International Cooperation, Societies, Medical, Clinical Trials as Topic organization & administration, Datasets as Topic standards, Editorial Policies, Information Dissemination, Periodicals as Topic standards
Abstract

El Comité Internacional de Editores de Revista Médicas (ICMJE) ha tomado la posición que el compartir los datos generados por los ensayos clínicos es una obligación ética, por cuanto los participantes en esos estudios se colocaron en riesgo al aceptar su inclusión. En esta editorial el ICMJE expresa que requerirá desde Julio 2018 que los manuscritos enviados a sus revistas deben incluir una declaración sobre compartir datos. A su vez, los ensayos clínicos que comiencen a enrolar pacientes a partir de Enero 2019, deben incluir un plan sobre compartir datos en el registro de tales ensayos. Se dan en esta declaración cuatro ejemplos de declaraciones sobre compartir datos, referidos a qué datos se compartirán, cuándo estarán disponibles y qué criterios de acceso se establecerán. El ICMJE visualiza un futuro cercano en el cual el compartir los datos será la norma, con el fin de maximizar el conocimiento ganado por los esfuerzos y sacrificios de los participantes.

Published
2017
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15. Data Sharing: An Ethical and Scientific Imperative.

Author

Bauchner H, Golub RM, and Fontanarosa PB

Subjects
Clinical Trials as Topic standards, Data Anonymization ethics, Data Anonymization standards, Humans, Publication Bias, Social Responsibility, Clinical Trials as Topic ethics, Data Interpretation, Statistical, Information Dissemination ethics, Research Subjects
Published
2016
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17. Sharing Clinical Trial Data: A Proposal From the International Committee of Medical Journal Editors.

Author

Taichman DB, Backus J, Baethge C, Bauchner H, de Leeuw PW, Drazen JM, Fletcher J, Frizelle FA, Groves T, Haileamlak A, James A, Laine C, Peiperl L, Pinborg A, Sahni P, and Wu S

Subjects
Humans, Information Dissemination ethics, Periodicals as Topic, Publishing, Registries, Advisory Committees, Clinical Trials as Topic ethics, Editorial Policies, Information Dissemination methods
Published
2016
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20. Sharing Clinical Trial Data.

Author

Taichman DB, Backus J, Baethge C, Bauchner H, de Leeuw PW, Drazen JM, Fletcher J, Frizelle FA, Groves T, Haileamlak A, James A, Lain C, Peiperl L, Pinborg A, Sahni P, and Wu S

Subjects
Editorial Policies, Internationality, Clinical Trials as Topic standards, Guidelines as Topic, Information Dissemination methods, Periodicals as Topic standards, Publishing standards, Self Disclosure
Published
2016
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21. Sharing Clinical Trial Data--A Proposal from the International Committee of Medical Journal Editors.

Author

Taichman DB, Backus J, Baethge C, Bauchner H, de Leeuw PW, Drazen JM, Fletcher J, Frizelle FA, Groves T, Haileamlak A, James A, Laine C, Peiperl L, Pinborg A, Sahni P, and Wu S

Subjects
Confidentiality, Consensus, Humans, Periodicals as Topic standards, Clinical Trials as Topic standards, Editorial Policies, Information Dissemination ethics, Publishing standards, Registries
Published
2016
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22. [Sharing clinical trial data: a proposal from the International Committee of Medical Journal Editors].

Author

Taichman DB, Backus J, Baethge C, Bauchner H, de Leeuw PW, Drazen JM, Fletcher J, Frizelle FA, Groves T, Haileamlak A, James A, Laine C, Peiperl L, Pinborg A, Sahni P, and Wu S

Subjects
Humans, Information Dissemination ethics, Periodicals as Topic, Publishing, Registries, Advisory Committees, Clinical Trials as Topic, Editorial Policies, Information Dissemination methods
Published
2016

23. Sharing clinical trial data: a proposal from the International Committee of Medical Journal Editors.

Author

Taichman DB, Backus J, Baethge C, Bauchner H, de Leeuw PW, Drazen JM, Fletcher J, Frizelle FA, Groves T, Haileamlak A, James A, Laine C, Peiperl L, Pinborg A, Sahni P, and Wu S

Subjects
Humans, Information Dissemination ethics, Periodicals as Topic, Publishing, Registries, Advisory Committees, Clinical Trials as Topic, Editorial Policies, Information Dissemination methods
Published
2016
Full Text
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24. Sharing clinical trial data.

Author

Taichman DB, Backus J, Baethge C, Bauchner H, de Leeuw PW, Drazen JM, Fletcher J, Frizelle FA, Groves T, Haileamlak A, James A, Laine C, Peiperl L, Pinborg A, Sahni P, and Wu S

Subjects
Humans, Clinical Trials as Topic, Editorial Policies, Information Dissemination, Periodicals as Topic
Published
2016
Full Text
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