Clinical trials are critical for drug development. Constructing the appropriate eligibility criteria (i.e., the inclusion/exclusion criteria for patient recruitment) is essential for the trial’s success. Proper design of clinical trial protocols should consider similar precedent trials and their eligibility criteria to ensure sufficient patient coverage. In this paper, we present a method named AutoTrial to aid the design of clinical eligibility criteria using language models. It allows (1) controllable generation under instructions via a hybrid of discrete and neural prompting, (2) scalable knowledge incorporation via in-context learning, and (3) explicit reasoning chains to provide rationales for understanding the outputs. Experiments on over 70K clinical trials verify that AutoTrial generates high-quality criteria texts that are fluent and coherent and with high accuracy in capturing the relevant clinical concepts to the target trial. It is noteworthy that our method, with a much smaller parameter size, gains around 60% winning rate against the GPT-3.5 baselines via human evaluations.

Patients with low health literacy usually have difficulty understanding medical jargon and the complex structure of professional medical language. Although some studies are proposed to automatically translate expert language into layperson-understandable language, only a few of them focus on both accuracy and readability aspects simultaneously in the clinical domain. Thus, simplification of the clinical language is still a challenging task, but unfortunately, it is not yet fully addressed in previous work. To benchmark this task, we construct a new dataset named MedLane to support the development and evaluation of automated clinical language simplification approaches. Besides, we propose a new model called DECLARE that follows the human annotation procedure and achieves state-of-the-art performance compared with eight strong baselines. To fairly evaluate the performance, we also propose three specific evaluation metrics. Experimental results demonstrate the utility of the annotated MedLane dataset and the effectiveness of the proposed model DECLARE.