Patient Considerations & Involvement

Participant experience

When introducing a different way of doing clinical trials to participants, the impact on participant experiences is an important component to evaluate. While DCTs promise to reduce the burden on trial participants and make participation more compatible with everyday life responsibilities, there is little knowledge about how moving trial activities to participants’ homes affects their experience and satisfaction. Participant satisfaction may be influenced by different trial components.

Recommendations

The use of digital technologies enables trial activities to be performed from the participant’s home, which allows for more flexibility in trial participation, and can therefore have a positive influence on the participant’s trial experience. When technology, which is often more present in DCTs, is not working, it can have a strong negative impact on the participant experience. Potential causes can be a malfunction of the device or increased time required for troubleshooting. We therefore advise trial design teams to deploy technologies that have not only been validated and tested to be user-friendly, but also to ensure their interoperability and compatibility with the wide array of combinations of hardware and operating systems encountered in the real-world, especially in a Bring-Your-Own-Device trial.

We found that both the provision and explanation of trial information and the competent and friendly interaction with trial staff, either remote or in-person, contributed to participants’ overall satisfaction. As participants valued the support they received from trial staff in the RADIAL trial (telemedicine calls, phone calls, home visits, on-site visits, depending on the trial arm), we advise providing a communication method which allows participants to ask questions easily. Participants should know who to contact and when, especially when in-person trial visits are not scheduled. We recommend the use of simple and understandable lay language when providing information and notifying participants about the results of medical tests and future support after the trial.

We recommend involving patients or patient representatives upfront to discuss the feasibility of trial activities, as, e.g., working people may have different time resources available for trial visits or data collection as opposed to retired people. In addition, certain trial activities, such as taking a blood sample or measuring blood pressure as part of the physical examination, may be challenging for some participants to conduct themselves. In such cases we advise offering alternatives for participants, such as having a nurse visiting the participant at home to take these measurements.

How Trials@Home reached these recommendations

We asked RADIAL participants to complete a questionnaire at three different time points over the course of the trial to evaluate the participant satisfaction in all three trial arms. Besides overall satisfaction with trial participation satisfaction was measured for specific decentralised elements,  information provided and trial staff contact. We also performed a database study to understand the purpose and use of physical examination in clinical trial protocols. Followed by interviews with various stakeholders to investigate whether a physical examination is always needed in a clinical trial and what opportunities exist for decentralisation of physical examination.

Further reading

Publications

Why and how do we perform physical examination(s) in clinical trials? A use case of drug intervention trials in type 2 diabetes mellitus.

Kopanz, et al
British Journal of Clinical Pharmacology
2025
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