Adoption of digital health solutions by clinical study teams

Peter Schaeffer

doi:10.17918/00011421

Clinical trials are essential for pharmaceutical drug development but have become increasingly complex, costly, and burdensome for participants, investigative sites, sponsors, and clinical study teams. Digital health solutions (DHS) including electronic consent, electronic clinical outcome assessments, remote monitoring technologies, and decentralized trial components have been positioned as an innovation that can reduce participant burden, improve data completeness, and support more flexible, participant centered evidence generation. Despite substantial investment and clear potential benefits, DHS adoption across clinical study teams remains uneven, suggesting that factors beyond technological capability influence adoption decisions. This study examines the organizational, cognitive, and experiential factors that shape clinical study teams' decisions to adopt DHS instead of traditional clinical trial methods. The research addresses the question: What factors influence pharmaceutical clinical study teams' decisions to adopt digital health solutions rather than traditional methods in clinical trials? To answer this question, the study employs a two-part quantitative design. The first component is a survey of clinical study team members in across the pharmaceutical and biotechnology organizations that measures four theoretically derived constructs: exploration-exploitation orientation, team learning capability, perceived illegitimacy of DHS-related tasks, and perceived third-party cooperation. The second component is an archival analysis of historical DHS adoption decisions at the study level, focusing on the prior DHS experience of three key decision-making roles. Together, these components capture both observable adoption behavior and the underlying mindsets and experiences that inform those decisions Survey-based analyses yielded limited support for the proposed predictors of DHS adoption. Exploitation orientation was negatively associated with adoption in the predicted direction, but the relationship was not statistically significant. Team learning capability, conceptualized as a higher-order construct comprising trusting team climate, relationship learning, and commitment, also did not emerge as a significant predictor. The third-party cooperative intention construct could not be reliably constructed from the survey data and was therefore not tested. In contrast, perceived illegitimacy of DHS-related tasks a construct was statistically significant predictor of DHS adoption, but in the opposite direction from that hypothesized: higher perceived illegitimacy was associated with greater reported DHS adoption. This suggests that DHS adoption may expose study teams to additional role demands and implementation burdens, and that perceptions of illegitimacy may function more as a consequence than a predictor. The archival analysis provided stronger support for the role of prior DHS experience. Across multiple model specifications, prior experience with DHS among asset lead role was a consistent and statistically significant predictor of study-level adoption decisions, even after controlling for study-level characteristics. Experience among study accountable person and project manager roles were significant in more limited models but attenuated when controls were introduced. These findings indicate that accumulated DHS experience particularly in strategic decision-making roles plays a meaningful role in shaping whether digital solutions are adopted in subsequent clinical studies. The study contributes to the literature by demonstrating that DHS adoption in clinical trials is not driven solely by individual technology acceptance or technical readiness. Instead, adoption reflects a process shaped by role-specific experience accumulation and the perceived legitimacy of DHS-related work. Theoretically, the findings suggest that DHS adoption should be viewed as a learning and legitimacy management process in regulated, team-based environments. Practically, the results imply that organizations seeking to increase DHS adoption should deliberately assign experienced asset lead roles to studies where DHS can add value and should address the distribution, support, and perceived fairness of DHS-related tasks within clinical study teams.

Adoption of digital health solutions by clinical study teams

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Adoption of digital health solutions by clinical study teams

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