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01.12.2012 | Research article | Ausgabe 1/2012 Open Access

BMC Medical Informatics and Decision Making 1/2012

Deficiencies in the transfer and availability of clinical trials evidence: a review of existing systems and standards

Zeitschrift:
BMC Medical Informatics and Decision Making > Ausgabe 1/2012
Autoren:
Gert van Valkenhoef, Tommi Tervonen, Bert de Brock, Hans Hillege
Wichtige Hinweise

Electronic supplementary material

The online version of this article (doi:10.​1186/​1472-6947-12-95) contains supplementary material, which is available to authorized users.

Competing interests

The authors declare that they have no competing interests.

Authors’ contributions

GvV carried out literature and internet searches and drafted the manuscript. TT carried out additional searches and drafted parts of the manuscript. BdB drafted parts of the manuscript. HH coordinated the study and helped to draft the manuscript. TT, BdB and HH critically commented on many versions of the manuscript. All authors read and approved the final manuscript.

Abstract

Background

Decisions concerning drug safety and efficacy are generally based on pivotal evidence provided by clinical trials. Unfortunately, finding the relevant clinical trials is difficult and their results are only available in text-based reports. Systematic reviews aim to provide a comprehensive overview of the evidence in a specific area, but may not provide the data required for decision making.

Methods

We review and analyze the existing information systems and standards for aggregate level clinical trials information from the perspective of systematic review and evidence-based decision making.

Results

The technology currently used has major shortcomings, which cause deficiencies in the transfer, traceability and availability of clinical trials information. Specifically, data available to decision makers is insufficiently structured, and consequently the decisions cannot be properly traced back to the underlying evidence. Regulatory submission, trial publication, trial registration, and systematic review produce unstructured datasets that are insufficient for supporting evidence-based decision making.

Conclusions

The current situation is a hindrance to policy decision makers as it prevents fully transparent decision making and the development of more advanced decision support systems. Addressing the identified deficiencies would enable more efficient, informed, and transparent evidence-based medical decision making.
Zusatzmaterial
Authors’ original file for figure 1
12911_2011_581_MOESM1_ESM.pdf
Authors’ original file for figure 2
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Authors’ original file for figure 3
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Authors’ original file for figure 4
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Authors’ original file for figure 5
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Authors’ original file for figure 6
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Literatur
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