Clinical trials technology provider Medable has reported data from a study where enhanced electronic informed consent (eIC) forms were demonstrated to boost patient comprehension and satisfaction in clinical trials.
The study was conducted in partnership with Duke University Department of Population Health Sciences’ Bioethics and Stakeholder (BASE) Lab in the US.
It compared subject comprehension and usability, preference and satisfaction of using enhanced eIC, which includes interactive videos and graphics, as against traditional text-only eIC forms.
The study involved 24 patients who analysed an eIC for a mock hypertension medication trial.
Participants were split into two groups: one reviewed the text-only eIC before the use of the enhanced version, while the other group did the opposite.
The demographic of the study population was diverse, covering various genders, ages, races, and geographic locations.
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According to the findings, 71% of the subjects found the enhanced eIC more informative, with digital elements making them feel more informed, engaged, comfortable and equipped to take part in clinical research.
The latest findings suggest that the inclusion of digital enhancements in eICs could lead to better outcomes for potential participants, not just in terms of understanding but also in engagement and satisfaction.
Medable chief scientific officer Dr Pamela Tenaerts said: “We will continue partnering with leading academia like Duke’s BASE Lab, Tufts CSDD, Harvard MRCT, and others to gather systematic evidence of technology’s impact on trial execution.
“Evidence of how new methodologies impact protocol performance and trial experience is how we will affect real change. Whether using AI, eIC, or other innovations, Medable is committed to leading responsible, evidence-driven clinical trial transformation.”
The new development came after Medable introduced new automation technology that reduced the amount of time it took to set up standard clinical trial procedures.
The company’s software-as-a-service platform has been utilised in more than 300 decentralised and hybrid trials across 60 countries.