Decentralized Clinical Trials and Time Burden: Important Considerations for Potential Clinical Trial Participants

OBJECTIVES: High participant burden in clinical trials has been a long-standing issue among standard site based clinical trials. This burden weighs heavily on the decision of potential study participants to enroll in and complete clinical trials. This study sought to elucidate preferences of potential clinical trial participants in for partaking in clinical trials.

METHODS: A digital survey was issued for 90 days in the US among n=217 men and women aged 18+. Respondents were asked two questions and given a series of statements of which they were asked to respond on a 5-point Likert scale. These two questions were, 1) “If you were considering participating in a clinical trial, how important would the following be to you?” and 2) “If you were considering participating in a clinical trial, how would each of these required activities affect your likelihood of participating in that clinical trial?”

RESULTS: For question 1, two of the top responses were “The distance I would have to travel for my trial visits” and “The number of visits and total time per month to participate in that trial” with 83% and 70% responding that it is “Very important/Important” respectively. For question 2, the top response was “Being able to collect trial data at home and provide health information remotely, via a website or a smartphone app” with 80% responding it would make them “Much more likely/More likely” to participate in the study.

CONCLUSIONS: Travel time, number of in person visits, and taken together, impact on participant time, is a major consideration for potential clinical trial participants. Decentralized clinical trials have strong potential to decrease time burden through reduction, or even elimination, of required in person site visits, thus reducing travel time, making clinical trials more attractive to prospective study participants.