Leveraging retooled clinical research infrastructure for Clinical Research Management System implementation at a large Academic Medical Center.

Quality clinical research is essential for health care progress and is the mission of academic health centers. Yet ensuring quality depends on an institution's ability to measure, control, and respond to metrics of trial performance. Uninformed clinical research provides little benefit to health care, drains institutional resources, and may waste participants' time and commitment. Opportunities for ensuring high-quality research are multifactorial, including training, evaluation, and retention of research workforces; operational efficiencies; and standardizing policies and procedures. Duke University School of Medicine has committed to improving the quality and informativeness of our clinical research enterprise through investments in infrastructure with significant focus on optimizing research management system integration as a foundational element for quality management. To address prior technology limitations, Duke has optimized Advarra's OnCore for this purpose by seamlessly integrating with the IRB system, electronic health record, and general ledger. Our goal was to create a standardized clinical research experience to manage research from inception to closeout. Key drivers of implementation include transparency of research process data and generating metrics aligned with institutional goals. Since implementation, Duke has leveraged OnCore data to measure, track, and report metrics resulting in improvements in clinical research conduct and quality.

Development of an integrated and comprehensive clinical trial process management system.

BACKGROUND: The process of initiating and completing clinical drug trials in hospital settings is highly complex, with numerous institutional, technical, and record-keeping barriers. In this study, we independently developed an integrated clinical trial management system (CTMS) designed to comprehensively optimize the process management of clinical trials. The CTMS includes system development methods, efficient integration with external business systems, terminology, and standardization protocols, as well as data security and privacy protection. METHODS: The development process proceeded through four stages, including demand analysis and problem collection, system design, system development and testing, system trial operation, and training the whole hospital to operate the system. The integrated CTMS comprises three modules: project approval and review management, clinical trial operations management, and background management modules. These are divided into seven subsystems and 59 internal processes, realizing all the functions necessary to comprehensively perform the process management of clinical trials. Efficient data integration is realized through extract-transform-load, message queue, and remote procedure call services with external systems such as the hospital information system (HIS), laboratory information system (LIS), electronic medical record (EMR), and clinical data repository (CDR). Data security is ensured by adopting corresponding policies for data storage and data access. Privacy protection complies with laws and regulations and de-identifies sensitive patient information. RESULTS: The integrated CTMS was successfully developed in September 2015 and updated to version 4.2.5 in March 2021. During this period, 1388 study projects were accepted, 43,051 electronic data stored, and 12,144 subjects recruited in the First Affiliated Hospital, Zhejiang University School of Medicine. CONCLUSION: The developed integrated CTMS realizes the data management of the entire clinical trials process, providing basic conditions for the efficient, high-quality, and standardized operation of clinical trials.

Re-engineering a Clinical Trial Management System Using Blockchain Technology: System Design, Development, and Case Studies.

BACKGROUND: A clinical trial management system (CTMS) is a suite of specialized productivity tools that manage clinical trial processes from study planning to closeout. Using CTMSs has shown remarkable benefits in delivering efficient, auditable, and visualizable clinical trials. However, the current CTMS market is fragmented, and most CTMSs fail to meet expectations because of their inability to support key functions, such as inconsistencies in data captured across multiple sites. Blockchain technology, an emerging distributed ledger technology, is considered to potentially provide a holistic solution to current CTMS challenges by using its unique features, such as transparency, traceability, immutability, and security. OBJECTIVE: This study aimed to re-engineer the traditional CTMS by leveraging the unique properties of blockchain technology to create a secure, auditable, efficient, and generalizable CTMS. METHODS: A comprehensive, blockchain-based CTMS that spans all stages of clinical trials, including a sharable trial master file system; a fast recruitment and simplified enrollment system; a timely, secure, and consistent electronic data capture system; a reproducible data analytics system; and an efficient, traceable payment and reimbursement system, was designed and implemented using the Quorum blockchain. Compared with traditional blockchain technologies, such as Ethereum, Quorum blockchain offers higher transaction throughput and lowers transaction latency. Case studies on each application of the CTMS were conducted to assess the feasibility, scalability, stability, and efficiency of the proposed blockchain-based CTMS. RESULTS: A total of 21.6 million electronic data capture transactions were generated and successfully processed through blockchain, with an average of 335.4 transactions per second. Of the 6000 patients, 1145 were matched in 1.39 seconds using 10 recruitment criteria with an automated matching mechanism implemented by the smart contract. Key features, such as immutability, traceability, and stability, were also tested and empirically proven through case studies. CONCLUSIONS: This study proposed a comprehensive blockchain-based CTMS that covers all stages of the clinical trial process. Compared with our previous research, the proposed system showed an overall better performance. Our system design, implementation, and case studies demonstrated the potential of blockchain technology as a potential solution to CTMS challenges and its ability to perform more health care tasks.

An integrated approach to improve clinical trial efficiency: Linking a clinical trial management system into the Research Integrated Network of Systems.

Low-accruing clinical trials delay translation of research breakthroughs into the clinic, expose participants to risk without providing meaningful clinical insight, increase the cost of therapies, and waste limited resources. By tracking patient accrual, Clinical and Translational Science Awards hubs can identify at-risk studies and provide them the support needed to reach recruitment goals and maintain financial solvency. However, tracking accrual has proved challenging because relevant patient- and protocol-level data often reside in siloed systems. To address this fragmentation, in September 2020 the South Carolina Clinical and Translational Research Institute, with an academic home at the Medical University of South Carolina, implemented a clinical trial management system (CTMS), with its access to patient-level data, and incorporated it into its Research Integrated Network of Systems (RINS), which links study-level data across disparate systems relevant to clinical research. Within the first year of CTMS implementation, 324 protocols were funneled through CTMS/RINS, with more than 2600 participants enrolled. Integrated data from CTMS/RINS have enabled near-real-time assessment of patient accrual and accelerated reimbursement from industry sponsors. For institutions with bioinformatics or programming capacity, the CTMS/RINS integration provides a powerful model for tracking and improving clinical trial efficiency, compliance, and cost-effectiveness.

[Construction of data remote monitoring and auditing system for clinical trials].

Clinical trial management system is independently developed by our hospital, which basically realized the whole process management and data collection of clinical trials. Based on the platform, the functional architecture of data remote monitoring and auditing was established. By desensitizing and encrypting of data, the project and subject hologram were visualized to facilitate to review of data. The data remote monitoring and auditing cloud platform adopts the B/S architecture pattern. Users register to apply for an account through the cloud platform, and access to the account via HTTPS security protocol. The authorized users were able to view the relevant items online to ensure the secure data transmission and easy operating. The electronic management of data is the direction of future efforts. By compliance with laws and regulations, the remote monitoring/auditing can be realized, and the data security and personal privacy can be ensured with the application of information technology. In this paper, the feasibility of remote monitoring/auditing mode is explored, specific technical schemes and system functions are suggested, and the realization scenarios are conceived in case of major public health emergencies.

Oncology Research: Clinical Trial Management Systems, Electronic Medical Record, and Artificial Intelligence.

OBJECTIVE: To discuss the implications of electronic systems and regulations regarding the use of electronic systems implemented during the conduct of a clinical trial and identify the impact of such platforms on oncology nurses' responsible for providing care to the research participant. DATA SOURCES: Peer-reviewed journal articles, internet, book chapters, and white papers. CONCLUSION: Electronic systems are being increasingly used in the conduct of clinical research. Electronic systems enable the capability to streamline data transfer, remote enrollment capabilities, greater transparency of the trial conduct, improved research documentation, and clearer audit trails. The oncology nurse is at the center of implementation of electronic systems to support the conduct of clinical research and enables safe and effective care to the research participant. IMPLICATIONS FOR NURSING PRACTICE: Oncology nurses are vital to the successful outcome of clinical research studies and are key members of the clinical research team. Electronic systems move beyond traditional data collection in clinical trials with multiple benefits. Such systems may enhance the successful completion and adherence of the clinical trial and maintain the safety of the individual consented to research trial.

Fully-Online, Interoperable Clinical Trial Management System for Multi-Interventional RCT: Maintain Your Brain Digital Platform.

Maintain Your Brain (MYB)i is a randomised controlled trial (RCT) of multiple online interventions designed to target modifiable risk factors for Alzheimer's disease and dementia. Traditional clinical trial management systems (CTMS) requirements consist of features such as management of the study, site, subject (participant), clinical outcomes, external and internal requests, education, data extraction and reporting, security, and privacy. In addition to fulfilling these traditional requirements, MYB has a specific set of features that needs to be fulfilled. These specific requirements include: (i) support for multiple interventions within a study, (ii) flexible interoperability options with third-party software providers, (iii) study participants being able to engage in online activities via web-based interfaces throughout the trial (from screening to follow-up), (iv) ability to algorithmically personalize trial activities based on the needs of the participant, and (v) the ability to handle large volumes of data over a long period. This paper outlines how the existing CTMSs fall short in meeting these specific requirements. The presented system architecture, development approach and lessons learned in the implementation of the MYB digital platform will inform researchers attempting to implement CTMSs for trials comparable to MYB in the future.

Construction of data remote monitoring and auditing system for clinical trials / 浙江大学学报·医学版

Clinical trial management system is independently developed by our hospital, which basically realized the whole process management and data collection of clinical trials. Based on the platform, the functional architecture of data remote monitoring and auditing was established. By desensitizing and encrypting of data, the project and subject hologram were visualized to facilitate to review of data. The data remote monitoring and auditing cloud platform adopts the B/S architecture pattern. Users register to apply for an account through the cloud platform, and access to the account via HTTPS security protocol. The authorized users were able to view the relevant items online to ensure the secure data transmission and easy operating. The electronic management of data is the direction of future efforts. By compliance with laws and regulations, the remote monitoring/auditing can be realized, and the data security and personal privacy can be ensured with the application of information technology. In this paper, the feasibility of remote monitoring/auditing mode is explored, specific technical schemes and system functions are suggested, and the realization scenarios are conceived in case of major public health emergencies.

The first step to the powers for clinical trials: a survey on the current and future Clinical Trial Management System.

A clinical trial management system (CTMS) is a comprehensive program that supports an efficient clinical trial. To improve the environment of clinical trials and to be competitive in the global clinical trials market, an advanced and integrated CTMS is necessary. However, there is little information about the status of CTMSs in Korea. To understand the utilization of current CTMSs and requirements for a future CTMS, we conducted a survey on the subjects related to clinical trials. The survey was conducted from July 27 to August 16, 2017. The total number of respondents was 596, and 531 of these responses were used. Almost half of the respondents were from hospitals (46%). The proportion of respondents who are currently using a CTMS was the highest for contract research organizations at 59%, whereas the proportion used by investigators was 39%. The main reason for not using a CTMS was that it is unnecessary and expensive, but it showed a difference between workplaces. Many respondents frequently used CTMSs to check the clinical trial schedule and progress status, which was needed regardless of workplace. While two-thirds of users tended to be satisfied with their current CTMS, there were many users who felt their CTMS was inconvenient. The most requested function for a future CTMS was one that could be used to manage the project schedule and subject enrollment status. Additionally, a systematic linkage to electronic medical records, including prescription and laboratory test results, and a function to confirm the participation history of subjects in other hospitals were requested.

The first step to the powers for clinical trials: a survey on the current and future Clinical Trial Management System

A clinical trial management system (CTMS) is a comprehensive program that supports an efficient clinical trial. To improve the environment of clinical trials and to be competitive in the global clinical trials market, an advanced and integrated CTMS is necessary. However, there is little information about the status of CTMSs in Korea. To understand the utilization of current CTMSs and requirements for a future CTMS, we conducted a survey on the subjects related to clinical trials. The survey was conducted from July 27 to August 16, 2017. The total number of respondents was 596, and 531 of these responses were used. Almost half of the respondents were from hospitals (46%). The proportion of respondents who are currently using a CTMS was the highest for contract research organizations at 59%, whereas the proportion used by investigators was 39%. The main reason for not using a CTMS was that it is unnecessary and expensive, but it showed a difference between workplaces. Many respondents frequently used CTMSs to check the clinical trial schedule and progress status, which was needed regardless of workplace. While two-thirds of users tended to be satisfied with their current CTMS, there were many users who felt their CTMS was inconvenient. The most requested function for a future CTMS was one that could be used to manage the project schedule and subject enrollment status. Additionally, a systematic linkage to electronic medical records, including prescription and laboratory test results, and a function to confirm the participation history of subjects in other hospitals were requested.

OpenGeneMed: a portable, flexible and customizable informatics hub for the coordination of next-generation sequencing studies in support of precision medicine trials.

Trials involving genomic-driven treatment selection require the coordination of many teams interacting with a great variety of information. The need of better informatics support to manage this complex set of operations motivated the creation of OpenGeneMed. OpenGeneMed is a stand-alone and customizable version of GeneMed (Zhao et al. GeneMed: an informatics hub for the coordination of next-generation sequencing studies that support precision oncology clinical trials. Cancer Inform 2015;14(Suppl 2):45), a web-based interface developed for the National Cancer Institute Molecular Profiling-based Assignment of Cancer Therapy (NCI-MPACT) clinical trial coordinated by the NIH. OpenGeneMed streamlines clinical trial management and it can be used by clinicians, lab personnel, statisticians and researchers as a communication hub. It automates the annotation of genomic variants identified by sequencing tumor DNA, classifies the actionable mutations according to customizable rules and facilitates quality control in reviewing variants. The system generates summarized reports with detected genomic alterations that a treatment review team can use for treatment assignment. OpenGeneMed allows collaboration to happen seamlessly along the clinical pipeline; it helps reduce errors made transferring data between groups and facilitates clear documentation along the pipeline. OpenGeneMed is distributed as a stand-alone virtual machine, ready for deployment and use from a web browser; its code is customizable to address specific needs of different clinical trials and research teams. Examples on how to change the code are provided in the technical documentation distributed with the virtual machine. In summary, OpenGeneMed offers an initial set of features inspired by our experience with GeneMed, a system that has been proven to be efficient and successful for coordinating the application of next-generation sequencing in the NCI-MPACT trial.

Architecture design of a generic centralized adjudication module integrated in a web-based clinical trial management system.

BACKGROUND: Centralized outcome adjudication has been used widely in multicenter clinical trials in order to prevent potential biases and to reduce variations in important safety and efficacy outcome assessments. Adjudication procedures could vary significantly among different studies. In practice, the coordination of outcome adjudication procedures in many multicenter clinical trials remains as a manual process with low efficiency and high risk of delay. Motivated by the demands from two large clinical trial networks, a generic outcome adjudication module has been developed by the network's data management center within a homegrown clinical trial management system. In this article, the system design strategy and database structure are presented. METHODS: A generic database model was created to transfer different adjudication procedures into a unified set of sequential adjudication steps. Each adjudication step was defined by one activate condition, one lock condition, one to five categorical data items to capture adjudication results, and one free text field for general comments. Based on this model, a generic outcome adjudication user interface and a generic data processing program were developed within a homegrown clinical trial management system to provide automated coordination of outcome adjudication. RESULTS: By the end of 2014, this generic outcome adjudication module had been implemented in 10 multicenter trials. A total of 29 adjudication procedures were defined with the number of adjudication steps varying from 1 to 7. The implementation of a new adjudication procedure in this generic module took an experienced programmer 1 or 2 days. A total of 7336 outcome events had been adjudicated and 16,235 adjudication step activities had been recorded. In a multicenter trial, 1144 safety outcome event submissions went through a three-step adjudication procedure and reported a median of 3.95 days from safety event case report form submission to adjudication completion. In another trial, 277 clinical outcome events were adjudicated by a six-step procedure and took a median of 23.84 days from outcome event case report form submission to adjudication procedure completion. CONCLUSION: A generic outcome adjudication module integrated in the clinical trial management system made the automated coordination of efficacy and safety outcome adjudication a reality.

Structure,Function and Operation Practice of Clinical Trial Management System in Our Hospital / 中国药房

OBJECTIVE:To promote the supervision and management of clinical trial by institution. METHODS:The structure and function of clinical trial management system(CTMS)developed by our hospital and other enterprise together were analyzed to evaluate the application and operation result of CTMS. RESULTS & CONCLUSIONS:CTMS of our hospital is made up of foun-dation,efficiency and strategy. It is equipped with role allocation,information exchange and report,information warning,drug tracking,clinical trial process control,quality control of electronic record,electronic signature and integration and connection with other system,etc. Relevant operation procedure is established to promote standardization and institutionalization of CTMS. Due to the application of CTMS,the cooperation among departments become smoother,and management level have been enhanced in dai-ly management,pharmacy management,subjects and document administration. It also simplifies the work of researcher and reduc-es the human error by the autogeneration of trial records and tables with the system. Consequently,the monitor coveraged through-out all the trial process.

The Analysis Based on Quality Function Deployment (QFD) Method of Clinical Trial Management System Requirements / 中华医学科研管理杂志

It is imperative to apply information technology in the area of management of clinical research so as to ensure the quality of clinical trials and to improve management efficiency.In this study,the based analysis method was the quality function deployment (QFD).This methodology is used to analysis the clinical trials management information system on a hospital directly under the Ministry of Health.It ensured user participation,lay a solid foundation for software engineers on system design.

PhactaManager: A Clinical Trial Management System Incorporating an XML Layer as a Database-Independent Processing Platform / 대한의료정보학회지

OBJECTIVE: Clinical trials are the most time-consuming and expensive part of the drug development process. Clinical Trial Management Systems (CTMSs) help sponsors of clinical trials manage all aspects of planning, performance, and reporting. Most conventional systems provide data processing functions using database management system (DBMS) procedures, which cause DBMS dependency problems. Thus, it is hard to handle the system by researchers who are unfamiliar with database. It is also difficult to share Electronic Case Report Forms (eCRFs) between institutions because conventional systems rely on specific software. METHODS: PhactaManager was developed for solving these problems by introducing an XML Layer in the application tier using an Entity-Attribute-Value model in the database tier. RESULTS: PhactaManager is a three-tier clinical trial management system that has an XML layer. The XML Layer provides a common DBMS independent eCRF document processing platform. Also we developed XML based eCRF Grammar to describe eCRF documents. The XML data elements described by eCRF grammar was constitute to eCRF by PhactaDesigner which an eCRF document design program. CONCLUSION: We achieved DBMS independency by implementing the XML Layer in PhactaManager. The Development of the eCRF Grammar enables the standardization of eCRF design, data correction and data sharing in multicenter clinical trial.