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BRIDGING THE DIGITAL DIVIDE: EMPOWERING CLINICAL TRIALS OFFICES FOR DECENTRALIZED CLINICAL TRIALS
Kochukoshy, Teena Ann
Kochukoshy, Teena Ann
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Thesis/Dissertation
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2025-05
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Business Administration/Strategic Management
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https://doi.org/10.34944/bsbt-6w92
Abstract
The traditional model of clinical trials, which is conducted in centralized locations, has been criticized for being costly, inefficient, and a hindrance to patient access. Decentralized clinical trials, in contrast, leverage digital platforms and technologies to bring clinical research closer to patients. Studies have reported that for pharmaceutical companies this has meant a reduction in lengthy trial timelines, faster development of drugs, and a potential reduction in financial burden. However, the successful execution of decentralized clinical trials hinges on empowering clinical trials offices. These offices face challenges in implementing digital technologies that are presently overlooked, leading to a lack of investment. Clinical trials offices require investment in training staff, integrating existing systems and working across various sponsors. This research explored the oversight of impact of digitalization on clinical trials offices through a structured survey. This method enabled the ability to understand the value of digitalization through the perspective of clinical trial offices. Results revealed that digital tool adoption led to a perceived reduction in staff turnover but a decrease in minority patient recruitment. The digital maturity of a clinical trials office revealed a perceived increase in data quality as there was more engaged in the implementation and execution of tools. Alternatively, study start-up timelines were perceived to have increased with digital tools being implemented bringing to light the complexity of the ecosystem’s clinical trials offices and their operations. A qualitative analysis of an open response question provided insights from key stakeholders involved in clinical trial management revealing issues with one-size fit all models of digital tools, the lack of oversight and training of staff as well as the engagement of key stakeholders as tools get vetted. This dissertation provides insight into the effects of digitalization on key metrics for clinical trials offices while bringing to light how far behind we still are at truly understanding the impact of investing and implementing digital tools in clinical trials offices.
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