J Biomed Inform - Analysis of eligibility criteria representation in industry-standard clinical trial protocols.


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Previous research on standardization of eligibility criteria and its feasibility has traditionally been conducted on clinical trial protocols from ClinicalTrials.gov (CT). The portability and use of such standardization for full-text industry-standard protocols has not been studied in-depth. Towards this end, in this study we first compare the representation characteristics and textual complexity of a set of Pfizer's internal full-text protocols to their corresponding entries in CT. Next, we identify clusters of similar criteria sentences from both full-text and CT protocols and outline methods for standardized representation of eligibility criteria. We also study the distribution of eligibility criteria in full-text and CT protocols with respect to pre-defined semantic classes used for eligibility criteria classification. We find that in comparison to full-text protocols, CT protocols are not only more condensed but also convey less information. We also find no correlation between the variations in word-counts of the ClinicalTrials.gov and full-text protocols. While we identify 65 and 103 clusters of inclusion and exclusion criteria from full text protocols, our methods found only 36 and 63 corresponding clusters from CT protocols. For both the full-text and CT protocols we are able to identify 'templates' for standardized representations with full-text standardization being more challenging of the two. In our exploration of the semantic class distributions we find that the majority of the inclusion criteria from both full-text and CT protocols belong to the semantic class "Diagnostic and Lab Results" while "Disease, Sign or Symptom" forms the majority for exclusion criteria. Overall, we show that developing a template set of eligibility criteria for clinical trials, specifically in their full-text form, is feasible and could lead to more efficient clinical trial protocol design.

Resumo Limpo

previous research standard elig criteria feasibl tradit conduct clinic trial protocol clinicaltrialsgov ct portabl use standard fulltext industrystandard protocol studi indepth toward end studi first compar represent characterist textual complex set pfizer intern fulltext protocol correspond entri ct next identifi cluster similar criteria sentenc fulltext ct protocol outlin method standard represent elig criteria also studi distribut elig criteria fulltext ct protocol respect predefin semant class use elig criteria classif find comparison fulltext protocol ct protocol condens also convey less inform also find correl variat wordcount clinicaltrialsgov fulltext protocol identifi cluster inclus exclus criteria full text protocol method found correspond cluster ct protocol fulltext ct protocol abl identifi templat standard represent fulltext standard challeng two explor semant class distribut find major inclus criteria fulltext ct protocol belong semant class diagnost lab result diseas sign symptom form major exclus criteria overal show develop templat set elig criteria clinic trial specif fulltext form feasibl lead effici clinic trial protocol design

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