Clinical Trials (CTs) remain the foundation of safe and effective drug development. Given the evolving data-driven and personalized medicine approach in healthcare, it is imperative for companies and regulators to utilize tailored Artificial Intelligence (AI) solutions that enable expeditious and streamlined clinical research. In this paper, we identified opportunities, challenges, and potential implications of AI in CTs.Following an extensive search in relevant databases and websites, we gathered publications tackling the use of AI and Machine Learning (ML) in CTs from the past 5 years in the US and Europe, including Regulatory Authorities' documents.Documented applications of AI commonly concern the oncology field and are mostly being applied in the area of recruitment. Main opportunities discussed aim to create efficiencies across CT activities, including the ability to reduce sample sizes, improve enrollment and conduct faster, more optimized adaptive CTs. While AI is an area of enthusiastic development, the identified challenges are ethical in nature and relate to data availability, standards, and most importantly, lack of regulatory guidance hindering the acceptance of AI tools in drug development. However, future implications are significant and are anticipated to improve the probability of success, reduce trial burden and overall, speed up research and regulatory approval.The use of AI in CTs is in its relative infancy; however, it is a fast-evolving field. As regulators provide more guidance on the acceptability of AI in specific areas, we anticipate the scope of use to broaden and the volume of implementation to increase rapidly. 

/pdf/artificial-intelligence-applied-to-clinical-trials-1qi6andg.pdf

Artificial Intelligence Applied to clinical trials: opportunities and challenges

Natural language processing (NLP) is an effective tool for generating structured information from unstructured data, the one that is commonly found in clinical trial texts. Such interdisciplinary research has gradually grown into a flourishing research field with accumulated scientific outputs available. In this study, bibliographical data collected from Web of Science, PubMed, and Scopus databases from 2001 to 2018 had been investigated with the use of three prominent methods, including performance analysis, science mapping, and, particularly, an automatic text analysis approach named structural topic modeling. Topical trend visualization and test analysis were further employed to quantify the effects of the year of publication on topic proportions. Topical diverse distributions across prolific countries/regions and institutions were also visualized and compared. In addition, scientific collaborations between countries/regions, institutions, and authors were also explored using social network analysis. The findings obtained were essential for facilitating the development of the NLP-enhanced clinical trial texts processing, boosting scientific and technological NLP-enhanced clinical trial research, and facilitating inter-country/region and inter-institution collaborations.

https://www.mdpi.com/2076-3417/10/6/2157/pdf

Trends and Features of the Applications of Natural Language Processing Techniques for Clinical Trials Text Analysis

Background: Clinical trials are an important step in introducing new interventions into clinical practice by generating data on their safety and efficacy. Clinical trials need to ensure that participants are similar so that the findings can be attributed to the interventions studied and not some other factors. Therefore, each clinical trial defines eligibility criteria, which describe characteristics that must be shared by the participants. Unfortunately, the complexities of eligibility criteria may not allow them to be translated directly into readily executable database queries. Instead, they may require careful analysis of the narrative sections of medical records. Manual screening of medical records is time consuming, thus negatively affecting the timeliness of the recruitment process. Objective: The Track 1 of the 2018 National NLP Clinical Challenge (n2c2) focused on the task of cohort selection for clinical trials with the aim of answering the following question: 'Can natural language processing be applied to narrative medical records to identify patients who meet eligibility criteria for clinical trials?' The task required the participating systems to analyze longitudinal patient records to determine if the corresponding patients met the given eligibility criteria. This article describes a system developed to address this task. Methods: Our system consists of 13 classifiers, one for each eligibility criterion. All classifiers use a bag-of-words document representation model. To prevent the loss of relevant contextual information associated with such representation, a pattern matching approach is used to extract context-sensitive features. They are embedded back into the text as lexically distinguishable tokens, which will consequently be featured in the bag-of-words representation. Supervised machine learning was chosen wherever a sufficient number of both positive and negative instances were available to learn from. A rule–based approach focusing on a small set of relevant features was chosen for the remaining criteria. Results: The system was evaluated using micro-averaged F–measure. Four machine algorithms, including support vector machine, logistic regression, naive Bayesian classifier and gradient tree boosting, were evaluated on the training data using 10–fold cross-validation. Overall, gradient tree boosting demonstrated the most consistent performance. Its performance peaked when oversampling was used to balance the training data. Final evaluation was performed on previously unseen test data. On average, the F-measure of 89.04% was comparable to three of the top ranked performances in the shared task (91.11%, 90.28% and 90.21%). With F-measure of 88.14%, we significantly outperformed these systems (81.03%, 78.50% and 70.81%) in identifying patients with advanced coronary artery disease. Conclusions: The holdout evaluation provides evidence that our system was able to identify eligible patients for the given clinical trial with high accuracy. Our approach demonstrates how rule-based knowledge infusion can improve the performance of machine learning algorithms even when trained on a relatively small dataset.

/pdf/cohort-selection-for-clinical-trials-from-longitudinal-1tf1h168ua.pdf

Cohort Selection for Clinical Trials From Longitudinal Patient Records: Text Mining Approach.

OUP accepted manuscript

Unstructured data from electronic health records represent a wealth of information. Doc'EDS is a pre-screening tool based on textual and semantic analysis. The Doc'EDS system provides a graphic user interface to search documents in French. The aim of this study was to present the Doc'EDS tool and to provide a formal evaluation of its semantic features.Doc'EDS is a search tool built on top of the clinical data warehouse developed at Rouen University Hospital. This tool is a multilevel search engine combining structured and unstructured data. It also provides basic analytical features and semantic utilities. A formal evaluation was conducted to measure the impact of Natural Language Processing algorithms.Approximately 18.1 million narrative documents are stored in Doc'EDS. The formal evaluation was conducted in 5000 clinical concepts that were manually collected. The F-measures of negative concepts and hypothetical concepts were respectively 0.89 and 0.57.In this formal evaluation, we have shown that Doc'EDS is able to deal with language subtleties to enhance an advanced full text search in French health documents. The Doc'EDS tool is currently used on a daily basis to help researchers to identify patient cohorts thanks to unstructured data. 

/pdf/evaluation-of-doceds-a-french-semantic-search-tool-to-query-10yuyi6z.pdf

Evaluation of Doc’EDS: a French semantic search tool to query health documents from a clinical data warehouse

Hybrid bag of approaches to characterize selection criteria for cohort identification

Although clozapine demonstrates unique efficacy for treatment-resistant schizophrenia, its impact on community-based services remains largely underexplored. The authors examined changes in use of community-based services after clozapine treatment among a sample of 163 patients with schizophrenia by using public claims data in Allegheny County, Pennsylvania. Mirror-image analyses of service utilization were used to compare the 180-day period before treatment initiation with the 180-day period that began after 6 months of adherent treatment, accounting for age, race, and gender. Across demographic variables, clozapine treatment was associated with increased use of community-based services and decreased use of psychiatric inpatient services (p<0.05, Bonferroni corrected), suggesting that clozapine treatment shifts service needs from emergency care to community-based care and recovery.

Community-Based Service Use After Clozapine Treatment: A Mirror-Image Analysis of Public Claims Data.

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Hybrid bag of approaches to characterize selection criteria for cohort identification

Community-Based Service Use After Clozapine Treatment: A Mirror-Image Analysis of Public Claims Data.