A novel semantic representation for eligibility criteria in clinical trials.
Eligibility Criteria (EC) comprise an important part of a clinical study, being determinant of its cost, duration and overall success. Their formal, computer-processable description can significantly improve clinical trial design and conduction by enabling their intelligent processing, replicability and linkability with other data. For EC representation purposes, related standards were investigated, along with published literature. Moreover, a considerable number of clinicaltrials.gov studies was analyzed in collaboration with clinical experts for the determination and classification of parameters of clinical research importance. The outcome of this process was the EC Representation; a CDISC-compliant schema for organizing criteria along with a patient-centric model for their formal expression, properly linked with international classifications and codifications. Its evaluation against 200 randomly selected EC indicated that it can adequately serve its purpose, while it can be also combined with existing tools and components developed for both EC specification and especially application to Electronic Health Records.
National Technical University of Athens, 9 Heroon Politechniou Str, 15773 Athens, Greece. Electronic address: chondrog@mail.ntua.gr.
Efthymios
E
Chondrogiannis
National Technical University of Athens, 9 Heroon Politechniou Str, 15773 Athens, Greece. Electronic address: vandro@mail.ntua.gr.
Vassiliki
V
Andronikou
National Technical University of Athens, 9 Heroon Politechniou Str, 15773 Athens, Greece. Electronic address: tastagar@biomed.ntua.gr.
Anastasios
A
Tagaris
National Technical University of Athens, 9 Heroon Politechniou Str, 15773 Athens, Greece. Electronic address: ekaranas@mail.ntua.gr.
Efstathios
E
Karanastasis
National Technical University of Athens, 9 Heroon Politechniou Str, 15773 Athens, Greece. Electronic address: dora@telecom.ntua.gr.
Theodora
T
Varvarigou
University of Hyogo, 7-1-28, Minatojima-Minami-cho, Chuo-ku, Kobe, Hyogo 650-0047, Japan. Electronic address: tsuji@ai.u-hyogo.ac.jp.
Masatsugu
M
Tsuji
D035843:Biomedical Research; D002986:Clinical Trials as Topic; D057225:Data Mining; D057286:Electronic Health Records; D006801:Humans; D018579:Patient Selection; D012660:Semantics
Bioinformatics; Clinical trials; Eligibility criteria representation; Reference models; Semantic web; Temporal constraints