Analysis of eligibility criteria representation in industry-standard clinical trial protocols
Analysis of eligibility criteria representation in industry-standard clinical trial protocols
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DOI：
10.1016/j.jbi.2013.06.001
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发表时间：
2013-10-01
影响因子：
4.5
通讯作者：
Cantor, Michael N.
中科院分区：
文献类型：
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作者：
Bhattacharya, Sanmitra;Cantor, Michael N.
以前关于合格标准标准化及其可行性的研究传统上是在ClinicalTrials.gov（CT）的临床试验方案上进行的。对于全文工业标准协议的可移植性和这种标准化的使用还没有深入研究。为此，在这项研究中，我们首先比较了一组辉瑞公司的内部全文协议的代表性特点和文本的复杂性，其相应的条目在CT。接下来，我们从全文和CT协议中识别出相似标准句子的集群，并概述了资格标准的标准化表示方法。我们还研究了在全文和CT协议的资格标准的分布与预定义的语义类用于资格标准分类。我们发现，与全文协议相比，CT协议不仅更精简，而且传达的信息更少。我们还发现ClinicalTrials.gov和全文协议的字数变化之间没有相关性。虽然我们从全文协议中确定了65和103个纳入和排除标准的集群，但我们的方法从CT协议中只找到了36和63个相应的集群。对于全文和CT协议，我们能够识别标准化表示的“模板”，其中全文标准化更具挑战性。在我们对语义类别分布的探索中，我们发现来自全文和CT方案的大多数入选标准属于语义类别“诊断和实验室结果”，而“疾病、体征或症状”形成了大多数排除标准。总体而言，我们表明，制定一套模板的资格标准的临床试验，特别是在其全文形式，是可行的，并可能导致更有效的临床试验方案设计。(C)2013 Elsevier Inc. All rights reserved.
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. (C) 2013 Elsevier Inc. All rights reserved.