scholarly journals Leveraging Blockchain Technology for Informed Consent Process and Patient Engagement in a Clinical Trial Pilot

2021 ◽  
Author(s):  
Baldwin C. Mak ◽  
Bryan T. Addeman ◽  
Jia Chen ◽  
Kim A. Papp ◽  
Melinda J. Gooderham ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Patient Empowerment ◽  
Visit Time ◽  
Trial Management ◽  
Trial Quality ◽  
Blockchain Technology ◽  
Monitoring Visit ◽  
Clinical Trial Management ◽  
The Impact ◽  
Trial Cost

Objective: Despite the implementation of quality assurance procedures, current clinical trial management processes are time-consuming, costly, and often susceptible to error. This can result in limited trust, transparency, and process inefficiencies, without true patient empowerment. The objective of this study was to determine whether blockchain technology could enforce trust, transparency, and patient empowerment in the clinical trial data management process, while reducing trial cost. Design: In this proof of concept pilot, we deployed a Hyperledger Fabric-based blockchain system in an active clinical trial setting to assess the impact of blockchain technology on mean monitoring visit time and cost, non-compliances, and user experience. Using a parallel study design, we compared differences between blockchain technology and standard methodology. Results: A total of 12 trial participants, seven study coordinators and three clinical research associates across five sites participated in the pilot. Blockchain technology significantly reduces total mean monitoring visit time and cost versus standard trial management (475 to 7 min; P = 0.001; €722 to €10; P = 0.001 per participant/visit, respectively), while enhancing patient trust, transparency, and empowerment in 91, 82 and 63% of the patients, respectively. No difference in non-compliances as a marker of trial quality was detected. Conclusion: Blockchain technology holds promise to improve patient-centricity and to reduce trial cost compared to conventional clinical trial management. The ability of this technology to improve trial quality warrants further investigation.

scholarly journals Patient Perspective of Blockchain Technology in Clinical Trial Management: A Proof of Concept Study (Preprint)

2019 ◽  
Author(s):  
Julia Feldman ◽  
Laura Pugliese ◽  
Katrina Mateo ◽  
Stan Kachnowski
Keyword(s):  
Clinical Trial ◽  
Clinical Trials ◽  
Patient Perspective ◽  
Health Data ◽  
Management Tool ◽  
Proof Of Concept ◽  
Trial Management ◽  
Concept Study ◽  
Blockchain Technology ◽  
Clinical Trial Management

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.

Clinical Trial Management and Remote Data Entry on the Internet

1999 ◽  
Vol 33 (4) ◽  
pp. 1061-1065 ◽  
Author(s):  
Roberto Scognamillo ◽  
Carlo Strozzi ◽  
Beatrice Vincenzi ◽  
Giuseppe Recchia
Keyword(s):  
Clinical Trial ◽  
Data Entry ◽  
The Internet ◽  
Trial Management ◽  
Clinical Trial Management ◽  
Remote Data

scholarly journals Expedited Safety Reporting Through an Alert System for Clinical Trial Management at an Academic Medical Center: Retrospective Design Study (Preprint)

2019 ◽  
Author(s):  
Yu Rang Park ◽  
HaYeong Koo ◽  
Young-Kwang Yoon ◽  
Sumi Park ◽  
Young-Suk Lim ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Clinical Trials ◽  
High Risk ◽  
Performance Indicators ◽  
Phase 1 ◽  
Low Risk ◽  
Alert System ◽  
Trial Management ◽  
Safety Reporting ◽  
Clinical Trial Management

BACKGROUND Early detection or notification of adverse event (AE) occurrences during clinical trials is essential to ensure patient safety. Clinical trials take advantage of innovative strategies, clinical designs, and state-of-the-art technologies to evaluate efficacy and safety, however, early awareness of AE occurrences by investigators still needs to be systematically improved. OBJECTIVE This study aimed to build a system to promptly inform investigators when clinical trial participants make unscheduled visits to the emergency room or other departments within the hospital. METHODS We developed the Adverse Event Awareness System (AEAS), which promptly informs investigators and study coordinators of AE occurrences by automatically sending text messages when study participants make unscheduled visits to the emergency department or other clinics at our center. We established the AEAS in July 2015 in the clinical trial management system. We compared the AE reporting timeline data of 305 AE occurrences from 74 clinical trials between the preinitiative period (December 2014-June 2015) and the postinitiative period (July 2015-June 2016) in terms of three AE awareness performance indicators: onset to awareness, awareness to reporting, and onset to reporting. RESULTS A total of 305 initial AE reports from 74 clinical trials were included. All three AE awareness performance indicators were significantly lower in the postinitiative period. Specifically, the onset-to-reporting times were significantly shorter in the postinitiative period (median 1 day [IQR 0-1], mean rank 140.04 [SD 75.35]) than in the preinitiative period (median 1 day [IQR 0-4], mean rank 173.82 [SD 91.07], <i>P</i>≤.001). In the phase subgroup analysis, the awareness-to-reporting and onset-to-reporting indicators of phase 1 studies were significantly lower in the postinitiative than in the preinitiative period (preinitiative: median 1 day, mean rank of awareness to reporting 47.94, vs postinitiative: median 0 days, mean rank of awareness to reporting 35.75, <i>P</i>=.01; and preinitiative: median 1 day, mean rank of onset to reporting 47.4, vs postinitiative: median 1 day, mean rank of onset to reporting 35.99, <i>P</i>=.03). The risk-level subgroup analysis found that the onset-to-reporting time for low- and high-risk studies significantly decreased postinitiative (preinitiative: median 4 days, mean rank of low-risk studies 18.73, vs postinitiative: median 1 day, mean rank of low-risk studies 11.76, <i>P</i>=.02; and preinitiative: median 1 day, mean rank of high-risk studies 117.36, vs postinitiative: median 1 day, mean rank of high-risk studies 97.27, <i>P</i>=.01). In particular, onset to reporting was reduced more in the low-risk trial than in the high-risk trial (low-risk: median 4-0 days, vs high-risk: median 1-1 day). CONCLUSIONS We demonstrated that a real-time automatic alert system can effectively improve safety reporting timelines. The improvements were prominent in phase 1 and in low- and high-risk clinical trials. These findings suggest that an information technology-driven automatic alert system effectively improves safety reporting timelines, which may enhance patient safety.

scholarly journals The Impact of Clinical Trial Quality Assurance on Outcome in Head and Neck Radiotherapy Treatment

2019 ◽  
Vol 9 ◽  
Author(s):  
Haoyu Zhong ◽  
Kuo Men ◽  
Jiazhou Wang ◽  
Johan van Soest ◽  
David Rosenthal ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Quality Assurance ◽  
Head And Neck ◽  
Trial Quality ◽  
The Impact ◽  
Head And Neck Radiotherapy ◽  
Radiotherapy Treatment
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