Science 37 and Tufts CSDD Publish Landmark Study on Direct-to-Patient Clinical Trial Site Performance, Outperforming Industry Benchmarks

Science 37 and the Tufts Center for the Study of Drug Development (Tufts CSDD) released a study in *Applied Clinical Trials* evaluating the performance of Science 37’s Direct-to-Patient (DTP) clinical trial model. The analysis compared 28 trials conducted through Science 37’s DTP Site—operating alongside traditional sites—against industry benchmarks for Phase II and Phase III studies. Results showed the DTP model enrolled 20-30% of total participants, averaging 150 patients per trial, compared to 26 patients per traditional site. Completion rates were significantly higher at 86% for DTP participants versus 36% in benchmarked traditional sites. The model also improved key timelines, including faster progression from first patient first visit to last patient first visit and database lock. Patient demographics were more representative, with 62.4% women enrolled (vs. 49% in benchmarks), 59.3% white participants (vs. 81.3%), and 19.9% Black participants (vs. 7%). Science 37’s DTP model operates under centralized medical oversight, featuring multi-state-licensed physicians and research-grade nurses for in-home visits. The model has passed multiple FDA inspections with No Action Indicated (NAI) classifications, meaning no Form 483 observations or significant findings were recorded. Data from these trials have supported regulatory submissions and approvals. Kenneth Getz, Executive Director of Tufts CSDD, noted that the study provides empirical evidence for the efficiency and accessibility benefits of DTP solutions, particularly when tailored to specific patient populations. The full study, available via *Applied Clinical Trials*, includes expanded datasets and methodology details. Tufts CSDD, a nonprofit research center within Tufts University School of Medicine, focuses on improving drug development processes. The collaboration highlights how hybrid DTP-traditional site approaches can enhance study performance while maintaining rigorous oversight.