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Deficiencies in the transfer and availability of clinical trials evidence: a review of existing systems and standards
- Source :
- BMC Medical Informatics and Decision Making, 12(95), 1-23. BioMed Central Ltd., BMC Medical Informatics and Decision Making, Vol 12, Iss 1, p 95 (2012), BMC Medical Informatics and Decision Making, BMC Medical Informatics and Decision Making, 12:95. BioMed Central Ltd.
- Publication Year :
- 2012
-
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.
- Subjects :
- PROTOCOLS
Decision support system
TRANSPARENCY
Databases, Pharmaceutical
RANDOMIZED CONTROLLED-TRIALS
Decision Making
Information Dissemination
Health Informatics
lcsh:Computer applications to medicine. Medical informatics
computer.software_genre
Health informatics
law.invention
Randomized controlled trial
law
Information system
Humans
Medicine
Registries
Policy Making
Clinical Trials as Topic
Evidence-Based Medicine
business.industry
STATEMENT
MEDICINE
Health Policy
Evidence-based medicine
Computer Science Applications
Clinical trial
ONTOLOGY
Systematic review
Risk analysis (engineering)
BIAS
HEALTH-CARE
REGISTRATION
PAPER
lcsh:R858-859.7
Data mining
business
computer
Research Article
Subjects
Details
- Language :
- English
- ISSN :
- 14726947
- Database :
- OpenAIRE
- Journal :
- BMC Medical Informatics and Decision Making, 12(95), 1-23. BioMed Central Ltd., BMC Medical Informatics and Decision Making, Vol 12, Iss 1, p 95 (2012), BMC Medical Informatics and Decision Making, BMC Medical Informatics and Decision Making, 12:95. BioMed Central Ltd.
- Accession number :
- edsair.doi.dedup.....1bd25f12d5181be5915472a60dee6811