Publication

Clinical trials information in drug development and regulation: existing systems and standards

Valkenhoef, G. V., Tervonen, T., Brock, B. D. & Hillege, H., 2012, Groningen: University of Groningen, SOM research school, 16 p. (SOM Research Reports; vol. 12003-Other).

Research output: Working paperAcademic

APA

Valkenhoef, G. V., Tervonen, T., Brock, B. D., & Hillege, H. (2012). Clinical trials information in drug development and regulation: existing systems and standards. (SOM Research Reports; Vol. 12003-Other). Groningen: University of Groningen, SOM research school.

Author

Valkenhoef, Gert van ; Tervonen, Tommi ; Brock, Bert de ; Hillege, Hans. / Clinical trials information in drug development and regulation : existing systems and standards. Groningen : University of Groningen, SOM research school, 2012. (SOM Research Reports).

Harvard

Valkenhoef, GV, Tervonen, T, Brock, BD & Hillege, H 2012 'Clinical trials information in drug development and regulation: existing systems and standards' SOM Research Reports, vol. 12003-Other, University of Groningen, SOM research school, Groningen.

Standard

Clinical trials information in drug development and regulation : existing systems and standards. / Valkenhoef, Gert van; Tervonen, Tommi; Brock, Bert de; Hillege, Hans.

Groningen : University of Groningen, SOM research school, 2012. (SOM Research Reports; Vol. 12003-Other).

Research output: Working paperAcademic

Vancouver

Valkenhoef GV, Tervonen T, Brock BD, Hillege H. Clinical trials information in drug development and regulation: existing systems and standards. Groningen: University of Groningen, SOM research school. 2012. (SOM Research Reports).


BibTeX

@techreport{233f334982b94eb28b4722d00e900ebe,
title = "Clinical trials information in drug development and regulation: existing systems and standards",
abstract = "Clinical trials provide pivotal evidence on drug efficacy and safety. The evidence, information from clinical trials, is currently used by regulatory decision makers in marketing authorization decisions, but only in an implicit manner. For clinical trials information to be used in a transparent and accountable way, it must be available in a format enabling efficient access and further processing, so that decisions can be explicitly linked to the underlying evidence. Thus, processing and management of clinical trials information plays a critical role in enabling transparent decisions. With the aim of identifying bottlenecks that prevent transparent decision making based on clinical trials evidence, we review the information systems and data standards that process clinical trials data in drug development and regulation. We find that while systems and standards for the management of single clinical trials are relatively mature, the transfer of information to the public and to decision makers is still an ad-hoc and text-based affair, and the integration of data from multiple studies remains difficult.",
author = "Valkenhoef, {Gert van} and Tommi Tervonen and Brock, {Bert de} and Hans Hillege",
note = "Relation: https://www.rug.nl/ Rights: University of Groningen",
year = "2012",
language = "English",
volume = "12003-Other",
series = "SOM Research Reports",
publisher = "University of Groningen, SOM research school",
type = "WorkingPaper",
institution = "University of Groningen, SOM research school",

}

RIS

TY - UNPB

T1 - Clinical trials information in drug development and regulation

T2 - existing systems and standards

AU - Valkenhoef, Gert van

AU - Tervonen, Tommi

AU - Brock, Bert de

AU - Hillege, Hans

N1 - Relation: https://www.rug.nl/ Rights: University of Groningen

PY - 2012

Y1 - 2012

N2 - Clinical trials provide pivotal evidence on drug efficacy and safety. The evidence, information from clinical trials, is currently used by regulatory decision makers in marketing authorization decisions, but only in an implicit manner. For clinical trials information to be used in a transparent and accountable way, it must be available in a format enabling efficient access and further processing, so that decisions can be explicitly linked to the underlying evidence. Thus, processing and management of clinical trials information plays a critical role in enabling transparent decisions. With the aim of identifying bottlenecks that prevent transparent decision making based on clinical trials evidence, we review the information systems and data standards that process clinical trials data in drug development and regulation. We find that while systems and standards for the management of single clinical trials are relatively mature, the transfer of information to the public and to decision makers is still an ad-hoc and text-based affair, and the integration of data from multiple studies remains difficult.

AB - Clinical trials provide pivotal evidence on drug efficacy and safety. The evidence, information from clinical trials, is currently used by regulatory decision makers in marketing authorization decisions, but only in an implicit manner. For clinical trials information to be used in a transparent and accountable way, it must be available in a format enabling efficient access and further processing, so that decisions can be explicitly linked to the underlying evidence. Thus, processing and management of clinical trials information plays a critical role in enabling transparent decisions. With the aim of identifying bottlenecks that prevent transparent decision making based on clinical trials evidence, we review the information systems and data standards that process clinical trials data in drug development and regulation. We find that while systems and standards for the management of single clinical trials are relatively mature, the transfer of information to the public and to decision makers is still an ad-hoc and text-based affair, and the integration of data from multiple studies remains difficult.

M3 - Working paper

VL - 12003-Other

T3 - SOM Research Reports

BT - Clinical trials information in drug development and regulation

PB - University of Groningen, SOM research school

CY - Groningen

ER -

ID: 15132901