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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

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