CONNECT-ClinicalTrials: An Empirical Study on Establishing an Online Consultation System for Clinical Trial Enrollment Using a Communication Application Among Medical Professionals

Abstract Background Clinical trial participation among patients with cancer remains limited, with particularly low rates in Japan. Structural challenges, including “drug lag” and “drug loss,” along with limited patient access to trial information and physician time constraints, hinder trial enrollment. Therefore, the National Cancer Center Hospital (NCCH) developed CONNECT-ClinicalTrials (COnsultation system of Nationwide oncology medical NEeds with online Communication Tool in Clinical Trials), a multicenter initiative leveraging the Join® communication platform to facilitate early trial eligibility assessments and streamline patient referrals. Methods This observational, non-interventional study aimed to evaluate the implementation of CONNECT-ClinicalTrials. Participating physicians from cooperating institutions submit patient data via Join®, enabling NCCH specialists to assess trial eligibility. Eligible patients may be formally referred to and enrolled in clinical trials. The data collected include patient demographics, clinical history, trial participation outcomes, and physician satisfaction. The primary endpoint is the proportion of referred patients enrolled in any clinical trial within three months of consultation. The study assessed 150 participants over two years, with follow-up extending to one year post-enrollment. The observed trial participation rate will be compared with the predefined threshold using binomial testing and Clopper–Pearson confidence intervals. Conclusion CONNECT-ClinicalTrials offer a scalable digital solution to enhance clinical trial access and mitigate disparities in trial enrollment. By improving inter-institutional communication and pre-screening efficiency, the system may contribute to reducing drug development delays in Japan and promoting equitable access to investigational therapies. CONNECT-ClinicalTrials could potentially be a national model for integrating community and academic cancer care in precision oncology.