Catálogo de publicaciones - libros
Clinical Trial Registries: A Practical Guide for Sponsors and Researchers of Medicinal Products
MaryAnn Foote (eds.)
Resumen/Descripción – provisto por la editorial
No disponible.
Palabras clave – provistas por la editorial
Pharmacology/Toxicology; Medicinal Chemistry
Disponibilidad
Institución detectada | Año de publicación | Navegá | Descargá | Solicitá |
---|---|---|---|---|
No detectada | 2006 | SpringerLink |
Información
Tipo de recurso:
libros
ISBN impreso
978-3-7643-7578-2
ISBN electrónico
978-3-7643-7583-6
Editor responsable
Springer Nature
País de edición
Reino Unido
Fecha de publicación
2006
Información sobre derechos de publicación
© Birkhäuser Verlag 2006
Cobertura temática
Tabla de contenidos
Clinical trial registries and publication of results — a primer
MaryAnn Foote
In the past years, the arena has suffered a remarkable development, where tools, such as , have been successfully applied in the design of medical systems. In this work, are applied to the prediction of organ dysfunction in . The novelty of this approach comes from the use of , which are triggered from four bedside alarms, being achieved an overall predictive accuracy of 70%.
Pp. 1-12
The journal editor’s perspective
Ana MarušiĆ; Charlotte Haug
In the past years, the arena has suffered a remarkable development, where tools, such as , have been successfully applied in the design of medical systems. In this work, are applied to the prediction of organ dysfunction in . The novelty of this approach comes from the use of , which are triggered from four bedside alarms, being achieved an overall predictive accuracy of 70%.
Pp. 13-26
Industry perspective on public clinical trial registries and results databases
Tracy Beck
In the past years, the arena has suffered a remarkable development, where tools, such as , have been successfully applied in the design of medical systems. In this work, are applied to the prediction of organ dysfunction in . The novelty of this approach comes from the use of , which are triggered from four bedside alarms, being achieved an overall predictive accuracy of 70%.
Pp. 27-46
Public and patient usage and expectations for clinical trial registries
Kenneth Getz
In the past years, the arena has suffered a remarkable development, where tools, such as , have been successfully applied in the design of medical systems. In this work, are applied to the prediction of organ dysfunction in . The novelty of this approach comes from the use of , which are triggered from four bedside alarms, being achieved an overall predictive accuracy of 70%.
Pp. 47-58
Building a global culture of trial registration
Karmela Krleža-Jerić
In the past years, the arena has suffered a remarkable development, where tools, such as , have been successfully applied in the design of medical systems. In this work, are applied to the prediction of organ dysfunction in . The novelty of this approach comes from the use of , which are triggered from four bedside alarms, being achieved an overall predictive accuracy of 70%.
Pp. 59-82
The Japanese perspective on registries and a review of clinical trial process in Japan
Hisako Matsuba; Takahiro Kiuchi; Kiichiro Tsutani; Eiji Uchida; Yasuo Ohashi
It is unclear where this debate is headed and how it will be resolved. It is important to remember that patients’ needs are quite different from the research community’s when it comes to clinical trial registries. The patient is interested in the number of different trials, the enrollment criteria, and the geographical proximity of the trial site so that he/she can make a decision about whether the trial is of potential interest. These are a mere subset of the 20 data elements that are under discussion and have little bearing on the transparency of clinical research that the remaining data elements are designed to address. p ]Finally, the role of the FDA must be fully recognized for what it is, an impartial review of all the data required to support a marketing application. Those who castigate the pharmaceutical industry indirectly impugn the integrity of the FDA. Pharmaceutical industry clinical research goes forward with the full knowledge that trial design and results will be critically examined. A product will not be licensed for marketing nor will an advertising claim be permitted unless the data support it.
Pp. 83-106
Transparency and validity of pharmaceutical research
Alan Goldhammer
It is unclear where this debate is headed and how it will be resolved. It is important to remember that patients’ needs are quite different from the research community’s when it comes to clinical trial registries. The patient is interested in the number of different trials, the enrollment criteria, and the geographical proximity of the trial site so that he/she can make a decision about whether the trial is of potential interest. These are a mere subset of the 20 data elements that are under discussion and have little bearing on the transparency of clinical research that the remaining data elements are designed to address. p ]Finally, the role of the FDA must be fully recognized for what it is, an impartial review of all the data required to support a marketing application. Those who castigate the pharmaceutical industry indirectly impugn the integrity of the FDA. Pharmaceutical industry clinical research goes forward with the full knowledge that trial design and results will be critically examined. A product will not be licensed for marketing nor will an advertising claim be permitted unless the data support it.
Pp. 107-118
A project management approach to the planning and execution of clinical trial registries
Mark Jungemann
In the past years, the arena has suffered a remarkable development, where tools, such as , have been successfully applied in the design of medical systems. In this work, are applied to the prediction of organ dysfunction in . The novelty of this approach comes from the use of , which are triggered from four bedside alarms, being achieved an overall predictive accuracy of 70%.
Pp. 119-133
Biopharmaceutical companies tackle clinical trial transparency
Dan McDonald; Steve Zisson
In the past years, the arena has suffered a remarkable development, where tools, such as , have been successfully applied in the design of medical systems. In this work, are applied to the prediction of organ dysfunction in . The novelty of this approach comes from the use of , which are triggered from four bedside alarms, being achieved an overall predictive accuracy of 70%.
Pp. 135-149
In search of “Clinical Trial Register — Version 2.0”
Lawrence E. Liberti; Lucy Erdelac; Jean Papaj
In the past years, the arena has suffered a remarkable development, where tools, such as , have been successfully applied in the design of medical systems. In this work, are applied to the prediction of organ dysfunction in . The novelty of this approach comes from the use of , which are triggered from four bedside alarms, being achieved an overall predictive accuracy of 70%.
Pp. 151-166