BACKGROUND
Blockchain is a technology that has emerged over the past 12 years with the potential to heighten security, data provenance, immutability and create a ‘patient centered experience’ when used in clinical trials. Although much of the recent literature discusses the potential for blockchain to benefit patients in these trials, no IRB-approved, independent study, has evaluated a blockchain-enabled clinical trial management tool from the patient perspective.
OBJECTIVE
The objective of this study was to determine the usability and feasibility of a blockchain-enabled clinical trials management platform with a connected activity tracker and blood pressure monitor through the perspective of patients. Specifically, this study aimed to assess the ability of the blockchain-enabled platform to support electronic consenting, participants’ engagement and compliance to study activities in the one-week period, and to assess the participants’ ability to successfully use and transmit health data via the connected devices.
METHODS
A rapid proof of concept study of a blockchain software platform used for patient eConsent, engagement and management in clinical trials was conducted. Participants were recruited using digital flyering on online forums (e.g. Craigslist) and by contacting participants from previous studies by the authors. To be eligible participants had to be native English speakers aged 18-75 who: 1) have been diagnosed with at least one chronic condition, and 2) possess an Android or iOS Smart Phone. Once enrolled, participants used the platform (webpage and smartphone app) and activity trackers (a Fitbit™ and iHealth™ devices) for a one-week period. Adherence data as well as perceptions of the platform were collected via semi-structured interviews and surveys at baseline and endline visits. Audio-recorded interviews were professionally transcribed and systematically coded.
RESULTS
15 chronically ill individuals with a mean age of 37.7 participated. Themes on opinions of the key properties of the blockchain technology emerged. Participants expressed that they valued transparency features of the blockchain tool because it would make doctors more accountable and potentially more cautious about the care they provide, which was especially important for patients with many doctors. Participants valued the ability to easily access, share and collect data remotely via the app because it saves money and time. Participants were highly interested in sharing their health records for clinical trials or being “matched” into trials. The heightened security of blockchain did not emerge as a major value because most expressed that they weren’t worried about keeping their health data secure.
CONCLUSIONS
Testing highlighted participants’ overall positive experience with the tool and trust that it could support their adherence to activities in the clinical trial, and that they would recommend the application be used in future studies. Participants believed that blockchain can improve the quality of care in clinical trials and were open to adopting it.
Using Blockchain Technology to Manage Clinical Trials Data: A Proof-of-Concept Study