The implementation of a data learning series focused on clinical development teams in a contract research organization

Effective management of a clinical trialrequires having real time access to information that provides useful insightsinto trial progress and that lends itself to collaborative decisionmaking.  Data visualizations using datafrom multiple source systems employed during the conduct of a clinical trialhave become an essential tool in the recent past as support for collaborativedecision making by project teams. Having the ability to access, analyze, read,work with, and present data to support an argument are  important skills that ensure datavisualizations fulfill their purpose in clinical trial management. There is anexpectation that members of the clinical trial team either possess or developthe data literacy skill sets necessary to collaborate on the successfulexecution of a clinical drug development trial. Here we describe thedevelopment of a Data Learning Series program targeted to increase the data literacyskills within a Contract Research Organization in support of the digitalevolution of the drug development industry.

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

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.

The Successful Synchronized Orchestration of an Investigator-Initiated Multicenter Trial Using a Clinical Trial Management System and Team Approach: Design and Utility Study (Preprint)

BACKGROUND As the cost of clinical trials continues to rise, novel approaches are required to ensure ethical allocation of resources. Multisite trials have been increasingly utilized in phase 1 trials for rare diseases and in phase 2 and 3 trials to meet accrual needs. The benefits of multisite trials include easier patient recruitment, expanded generalizability, and more robust statistical analyses. However, there are several problems more likely to arise in multisite trials, including accrual inequality, protocol nonadherence, data entry mistakes, and data integration difficulties. OBJECTIVE The Biostatistics & Data Science department at the University of Kansas Medical Center developed a clinical trial management system (comprehensive research information system [CRIS]) specifically designed to streamline multisite clinical trial management. METHODS A National Institute of Child Health and Human Development–funded phase 3 trial, the ADORE (assessment of docosahexaenoic acid [DHA] on reducing early preterm birth) trial fully utilized CRIS to provide automated accrual reports, centralize data capture, automate trial completion reports, and streamline data harmonization. RESULTS Using the ADORE trial as an example, we describe the utility of CRIS in database design, regulatory compliance, training standardization, study management, and automated reporting. Our goal is to continue to build a CRIS through use in subsequent multisite trials. Reports generated to suit the needs of future studies will be available as templates. CONCLUSIONS The implementation of similar tools and systems could provide significant cost-saving and operational benefit to multisite trials. CLINICALTRIAL ClinicalTrials.gov NCT02626299; https://tinyurl.com/j6erphcj

Nursing’s Role in Translating Safe Communication Practices to Clinical Trial Management

There is great emphasis on safety-related communication best practices in healthcare. However, little is known about safety-related communication within clinical trial management. Clinical trial participants are at greater risk for adverse events, injury, and trial withdrawal when seeking care outside of the trial when external providers are not aware of protocol constraints with care management. Nurses are traditionally the first providers to gather or denote importance on pertinent information when a participant seeks care. The World Health Organization (WHO) 2014 Minimum Information Model for Patient Safety and the SACCIA Safe Communication framework support identification of communication errors that place participants at risk. Implementation of these frameworks by providers can promote accuracy, clarity, context, and actionable decision-making that is in alignment to protocol mandated requirements for care. This paper reviews participant-nurse communication and provides recommendations for effective communication with clinical trial participants who seek care external to the trial.

Perspective: Guidelines Needed for the Conduct of Human Nutrition Randomized Controlled Trials

ABSTRACT Guidelines for designing, conducting, documenting, and reporting human nutrition randomized controlled trials (RCTs) have as yet to be developed and disseminated as reference for investigators, funders, regulators, institutions, assessors, trainees, and others involved in human nutrition research. Diet-related interventions can include diet and/or behavioral manipulation, provision of foods or entire meals, or delivery of dietary components in individual food items or supplements. This Perspective introduces a series of papers that outline core principles for the design and conduct of human nutrition RCTs, documentation and reporting of all aspects of clinical trial management, and data analysis and reporting of results. Human nutrition RCTs have unique considerations delineated in these papers. Conducting them with the highest scientific rigor is essential to the development of evidence-based dietary guidance for promoting optimal health and advancing health care.

Expedited Safety Reporting to Sponsors Through the Implementation of an Alert System for Clinical Trial Management at an Academic Medical Center: Retrospective Design Study

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], P≤.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, P=.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, P=.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, P=.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, P=.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.