Remote Monitoring and Data Collection for Decentralized Clinical Trials.

Importance: Less than 5% of patients with cancer enroll in a clinical trial, partly due to financial and logistic burdens, especially among underserved populations. The COVID-19 pandemic marked a substantial shift in the adoption of decentralized trial operations by pharmaceutical companies. Objective: To assess the current global state of adoption of decentralized trial technologies, understand factors that may be driving or preventing adoption, and highlight aspirations and direction for industry to enable more patient-centric trials. Design, Setting, and Participants: The Bloomberg New Economy International Cancer Coalition, composed of patient advocacy, industry, government regulator, and academic medical center representatives, developed a survey directed to global biopharmaceutical companies of the coalition from October 1 through December 31, 2022, with a focus on registrational clinical trials. The data for this survey study were analyzed between January 1 and 31, 2023. Exposure: Adoption of decentralized clinical trial technologies. Main Outcomes and Measures: The survey measured (1) outcomes of different remote monitoring and data collection technologies on patient centricity, (2) adoption of these technologies in oncology and all therapeutic areas, and (3) barriers and facilitators to adoption using descriptive statistics. Results: All 8 invited coalition companies completed the survey, representing 33% of the oncology market by revenues in 2021. Across nearly all technologies, adoption in oncology trials lags that of all trials. In the current state, electronic diaries and electronic clinical outcome assessments are the most used technology, with a mean (SD) of 56% (19%) and 51% (29%) adoption for all trials and oncology trials, respectively, whereas visits within local physician networks is the least adopted at a mean (SD) of 12% (18%) and 7% (9%), respectively. Looking forward, the difference between the current and aspired adoption rate in 5 years for oncology is large, with respondents expecting a 40% or greater absolute adoption increase in 8 of the 11 technologies surveyed. Furthermore, digitally enabled recruitment, local imaging capabilities, and local physician networks were identified as technologies that could be most effective for improving patient centricity in the long term. Conclusions and Relevance: These findings may help to galvanize momentum toward greater adoption of enabling technologies to support a new paradigm of trials that are more accessible, less burdensome, and more inclusive.

From music to macromolecules: using rich media/podcast lecture recordings to enhance the preclinical educational experience.

BACKGROUND: Little is known regarding the impact of lecture recordings on medical education. AIM: This study was designed to assess the impact of lecture recordings on the educational experience of first-year medical students. METHODS: Students were provided with digital lecture recordings in Molecular Foundations of Medicine, an integrated preclinical science block. Students could access recordings as audio/visual rich media, in which lectures were linked to slide presentations, and as audio-only podcasts. Student reactions were assessed by a mandatory questionnaire on the use of recordings and by a voluntary follow-up questionnaire on the effects of recordings on learning, stress and anxiety. RESULTS: Student response to lecture recordings was universally positive. A high proportion of the class accessed recordings, with rich media being the preferred format. Students felt that the lecture recordings helped them learn course material and reduced stress and anxiety. Finally, the availability of lecture recordings had no apparent adverse effect on classroom attendance. CONCLUSIONS: The availability of lecture recordings aided medical students in their studies and reduced stress and anxiety. Student response to the recordings was universally positive, and no negative outcomes were noted by students or faculty.