Exploring the Generalization of Cancer Clinical Trial Eligibility Classifiers Across Diseases

Clinical trials are pivotal in medical research, and NLP can enhance their success, with application in recruitment. This study aims to evaluate the generalizability of eligibility classification across a broad spectrum of clinical trials. Starting with phase 3 cancer trials, annotated with seven eligibility exclusions, then to determine how well models can generalize to non-cancer and non-phase 3 trials. To assess this, we have compiled eligibility criteria data for five types of trials: (1) additional phase 3 cancer trials, (2) phase 1 and 2 cancer trials, (3) heart disease trials, (4) type 2 diabetes trials, and (5) observational trials for any disease, comprising 2,490 annotated eligibility criteria across seven exclusion types. Our results show that models trained on the extensive cancer dataset can effectively handle criteria commonly found in non-cancer trials, such as autoimmune diseases. However, they struggle with criteria disproportionately prevalent in cancer trials, like prior malignancy. We also experiment with few-shot learning, demonstrating that a limited number of disease-specific examples can partially overcome this performance gap. We are releasing this new dataset of annotated eligibility statements to promote the development of cross-disease generalization in clinical trial classification.

Text Classification of Cancer Clinical Trial Eligibility Criteria

Automatic identification of clinical trials for which a patient is eligible is complicated by the fact that trial eligibility is stated in natural language. A potential solution to this problem is to employ text classification methods for common types of eligibility criteria. In this study, we focus on seven common exclusion criteria in cancer trials: prior malignancy, human immunodeficiency virus, hepatitis B, hepatitis C, psychiatric illness, drug/substance abuse, and autoimmune illness. Our dataset consists of 764 phase III cancer trials with these exclusions annotated at the trial level. We experiment with common transformer models as well as a new pre-trained clinical trial BERT model. Our results demonstrate the feasibility of automatically classifying common exclusion criteria. Additionally, we demonstrate the value of a pre-trained language model specifically for clinical trials, which yields the highest average performance across all criteria.