Journal:Development of an integrated and comprehensive clinical trial process management system

Full article title	Development of an integrated and comprehensive clinical trial process management system
Journal	BMC Medical Informatics and Decision Making
Author(s)	Shen, Liang; Zhai, You; Pan, AXiang; Zhao, Qingwei; Zhou, Min; Lio, Jian
Author affiliation(s)	Zhejiang University School of Medicine
Primary contact	Email: minzhou at zju dot edu dot cn
Year published	2023
Volume and issue	23
Article #	61
DOI	10.1186/s12911-023-02158-8
ISSN	1472-6947
Distribution license	Creative Commons Attribution 4.0 International
Website	https://bmcmedinformdecismak.biomedcentral.com/articles/10.1186/s12911-023-02158-8
Download	https://bmcmedinformdecismak.biomedcentral.com/counter/pdf/10.1186/s12911-023-02158-8.pdf (PDF)

Abstract

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 (ETL), 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, 1,388 study projects were accepted, 43,051 electronic data files 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.

Keywords: clinical trial, clinical trial management system (CTMS), information technology, integrated management system, medical informatics

Background

Clinical trials of drugs are an important stage in drug research and development and are means to improve the development of medical science and technology. [1,2,3,4,5]. Standardizing the management of clinical research is key to simplifying the research process, improving quality, and ensuring the accuracy, reliability, and integrity of the results, thereby shortening the development cycle of new drugs and accelerating the process of drug registration. [6]

In China, each hospital has a dedicated clinical trial management department, called a clinical trial institution (CTI), responsible for the administrative management of clinical trial operation in the hospital. This involves determining the project leader, formulating research plans with sponsors, reviewing the plans with the ethics committee, signing research contracts, screening and enrolling subjects, originating records of trials, receiving drugs, distributing and recovering, processing or reporting adverse events (AE) or serious adverse events (SAE), managing in-hospital quality, accepting supervision and inspection, summarizing, and filing. The traditional management mode is based on paper documents and involves considerable manual labor, which often leads to untimely information updates, ineffective management, and unverifiable quality.

Today, the rapid development of internet technology has profoundly impacted the mode of clinical trial management. Diverse companies have developed a series of network management systems for clinical trials. [7, 8] Most of these systems have been developed based on the research and development (R&D) requirements of pharmaceutical companies. Clinical trials are managed in a networked manner, which only handles project-related data and excludes the process management links of the clinical trial organization. These commercialized clinical trial management systems (CTMSs) provide comprehensive clinical trial management services, supporting all types of clinical trials, from Phase I to Phase III, from a trial conducted in a single research center to multinational clinical trials; thus, they improve the quality of clinical trials and the efficiency of data management. However, from the perspective of drug clinical trial institutions, this type of CTMS cannot satisfy the practical requirements for real-time and effective management of all clinical trials carried out by these institutions. Hence, a new CTMS has been developed as an institutional management model in China. Its development and application are still in their infancy. The CTMS also faces certain incompatibility issues with the hospital database. It is difficult to achieve data sharing and docking. Moreover, the management method is still relatively primitive. The degree of digitalization, networking, and standardization of clinical trials is relatively low, and it is practically impossible for institutions to effectively manage clinical trials.

In recent years, owing to the increase in clinical trial projects in our hospital, professional and standardized information systems were urgently needed to assist in the management of clinical trials throughout the hospital. At present, the need for a centralized clinical trial project management platform reliant on the clinical data system of the hospital itself is intensifying. Based on the local area network (LAN) security architecture of our hospital, we have constructed a CTMS, which organically integrates the clinical trial organization management office, ethics committee, clinical trial center pharmacy, and clinical professional departments. The management system covers the entire process of clinical trials, including trial project establishment, ethical review, signing of agreements, trial implementation, trial conclusion, sponsor management, subject management, follow-up management, and centralized management of pharmacies supporting medication trials. The personnel involved include clinical departments, institutional management offices, central pharmacies, and ethics committees. With the help of the information system, a large number of personnel and complicated work processes are now more organically integrated to realize information sharing and collaborative work. With the help of this CTMS, the implementation of clinical trials can be standardized and the entire process can be traceable.

As a site of clinical trials, hospital management involves multi-party collaboration, as well as study project management, subject management, investigational product management, quality control, financial management, and other complex business processes. Hospitals must develop dedicated systems to assist the entire process management of clinical trials to ensure their efficient and high-quality operation.

The main objectives of this study are as follows. We aim (1) to develop an integrated CTMS as a dedicated database for clinical trials; (2) to achieve efficient data integration of the CTMS with hospital business systems such as the hospital information system (HIS), laboratory information system (LIS), clinical data repository (CDR), picture archiving and communication system (PACS), and electronic medical record (EMR); (3) to facilitate standardization and consistency of terminology in the development of database models and business processes; and (4) to ensure the safety and security of clinical data as well as protect patient privacy to comply with relevant regulations.

Notes

This presentation is faithful to the original, with only a few minor changes to presentation, grammar, and punctuation. In some cases important information was missing from the references, and that information was added.