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Participant recruitment and retention are significant challenges that clinical trial sponsors face, especially with increasingly complex trial protocols. Participating in a clinical trial may be burdensome in a variety of ways, negatively impacting participants’ overall experience and jeopardizing their sustained enrollment. While participants are typically compensated for participation in clinical trials and may experience therapeutic benefits, some scholars argue that more should be done to minimize participant burden. Clinical researchers have an obligation to minimize burden and harm while maximizing the potential benefits of trial participation, as reflected by the bioethical principle of justice. Though participant burden is a common term discussed in the clinical research community, how research participants conceptualize burden associated with their clinical trial participation is not consistently understood and addressed by researchers.
This capstone project will provide an overview of the role of technology in clinical trials, summarize both its benefits and burdens, and provide researchers with tangible recommendations on how to approach technology-related considerations when planning clinical trials.
Learning Objectives:
Explain the growing and evolving role of technology use in clinical trials, including the impact of the COVID-19 pandemic
Summarize the benefits and potential burdens of technology use in clinical trials
Suggest tangible recommendations to clinical trial sponsors regarding how they should approach technology-related considerations and decisions when planning clinical trials
