scholarly journals A Good Practice–Compliant Clinical Trial Imaging Management System for Multicenter Clinical Trials: Development and Validation Study

10.2196/14310 ◽  
2019 ◽  
Vol 7 (3) ◽  
pp. e14310 ◽  
Author(s):  
Youngbin Shin ◽  
Kyung Won Kim ◽  
Amy Junghyun Lee ◽  
Yu Sub Sung ◽  
Suah Ahn ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Clinical Trials ◽  
Management System ◽  
Good Practice ◽  
Functional Requirements ◽  
System Validation ◽  
Multicenter Clinical Trials ◽  
Computerized System ◽  
Client System ◽  
Server System

Background With the rapid increase in utilization of imaging endpoints in multicenter clinical trials, the amount of data and workflow complexity have also increased. A Clinical Trial Imaging Management System (CTIMS) is required to comprehensively support imaging processes in clinical trials. The US Food and Drug Administration (FDA) issued a guidance protocol in 2018 for appropriate use of medical imaging in accordance with many regulations including the Good Clinical Practice (GCP) guidelines. Existing research on CTIMS, however, has mainly focused on functions and structures of systems rather than regulation and compliance. Objective We aimed to develop a comprehensive CTIMS to meet the current regulatory guidelines and various required functions. We also aimed to perform computerized system validation focusing on the regulatory compliance of our CTIMS. Methods Key regulatory requirements of CTIMS were extracted thorough review of many related regulations and guidelines including International Conference on Harmonization-GCP E6, FDA 21 Code of Federal Regulations parts 11 and 820, Good Automated Manufacturing Practice, and Clinical Data Interchange Standards Consortium. The system architecture was designed in accordance with these regulations by a multidisciplinary team including radiologists, engineers, clinical trial specialists, and regulatory medicine professionals. Computerized system validation of the developed CTIMS was performed internally and externally. Results Our CTIMS (AiCRO) was developed based on a two-layer design composed of the server system and the client system, which is efficient at meeting the regulatory and functional requirements. The server system manages system security, data archive, backup, and audit trail. The client system provides various functions including deidentification, image transfer, image viewer, image quality control, and electronic record. Computerized system validation was performed internally using a V-model and externally by a global quality assurance company to demonstrate that AiCRO meets all regulatory and functional requirements. Conclusions We developed a Good Practice–compliant CTIMS—AiCRO system—to manage large amounts of image data and complexity of imaging management processes in clinical trials. Our CTIMS adopts and adheres to all regulatory and functional requirements and has been thoroughly validated.

scholarly journals A Good Practice–Compliant Clinical Trial Imaging Management System for Multicenter Clinical Trials: Development and Validation Study (Preprint)

2019 ◽  
Author(s):  
Youngbin Shin ◽  
Kyung Won Kim ◽  
Amy Junghyun Lee ◽  
Yu Sub Sung ◽  
Suah Ahn ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Clinical Trials ◽  
Management System ◽  
Good Practice ◽  
Functional Requirements ◽  
System Validation ◽  
Multicenter Clinical Trials ◽  
Computerized System ◽  
Client System ◽  
Server System

BACKGROUND With the rapid increase in utilization of imaging endpoints in multicenter clinical trials, the amount of data and workflow complexity have also increased. A Clinical Trial Imaging Management System (CTIMS) is required to comprehensively support imaging processes in clinical trials. The US Food and Drug Administration (FDA) issued a guidance protocol in 2018 for appropriate use of medical imaging in accordance with many regulations including the Good Clinical Practice (GCP) guidelines. Existing research on CTIMS, however, has mainly focused on functions and structures of systems rather than regulation and compliance. OBJECTIVE We aimed to develop a comprehensive CTIMS to meet the current regulatory guidelines and various required functions. We also aimed to perform computerized system validation focusing on the regulatory compliance of our CTIMS. METHODS Key regulatory requirements of CTIMS were extracted thorough review of many related regulations and guidelines including International Conference on Harmonization-GCP E6, FDA 21 Code of Federal Regulations parts 11 and 820, Good Automated Manufacturing Practice, and Clinical Data Interchange Standards Consortium. The system architecture was designed in accordance with these regulations by a multidisciplinary team including radiologists, engineers, clinical trial specialists, and regulatory medicine professionals. Computerized system validation of the developed CTIMS was performed internally and externally. RESULTS Our CTIMS (AiCRO) was developed based on a two-layer design composed of the server system and the client system, which is efficient at meeting the regulatory and functional requirements. The server system manages system security, data archive, backup, and audit trail. The client system provides various functions including deidentification, image transfer, image viewer, image quality control, and electronic record. Computerized system validation was performed internally using a V-model and externally by a global quality assurance company to demonstrate that AiCRO meets all regulatory and functional requirements. CONCLUSIONS We developed a Good Practice–compliant CTIMS—AiCRO system—to manage large amounts of image data and complexity of imaging management processes in clinical trials. Our CTIMS adopts and adheres to all regulatory and functional requirements and has been thoroughly validated.

Registration of Rectal Cancer-Related Clinical Trials on Chinese Clinical Trial Registry over past decades

2020 ◽  
Author(s):  
Jun-hong Hu ◽  
Shi-Can Zhou ◽  
Quan Zhang ◽  
Xing- Wang Li ◽  
Chen-Yu Wang ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Rectal Cancer ◽  
Clinical Trials ◽  
Trial Registry ◽  
Clinical Trial Registry ◽  
Clinical Trial Registration ◽  
Hospital Funding ◽  
Local Finance ◽  
Multicenter Clinical Trials ◽  
Data Library

Abstract Background This study investigated and analyzed rectal cancer-related clinical trials registered on Chinese Clinical Trial Registry (Chi-CTR) by the end of 2018. We aimed to discuss the characteristics and developmental trends. Methods The Chi-CTR database was searched and all clinical trials related to rectal cancer extracted. The time limit for the search was from the establishment of the data library to December 31, 2018. The characteristics of registered clinical trials were then analyzed. Results A total of 70 clinical trials were retreived. Beijing, Shandong, and Guangzhou accounted for 47.1% of the total number of registered clinical trials. Sichuan and Sun Yat-sen Universities having the highest number of registrations. The registration status of the 55 trials was prospective registration. The top sources of funding were self-financing (41.4%), hospital funding (22.9%) and local finance (15.7%). Out of the 43 randomized controlled trials, 39 were either blank or missing in the blinded section. The sample size of clinical trials was high in 100 to 199 cases. Only eight of the 70 trials were multicenter clinical trials. Conclusions Relevant departments should increase the registration of clinical trials, increase the awareness of registration, and promote the development of high-quality clinical trials. At the same time, researchers should raise the awareness of clinical trial registration, and actively carry out multi-center clinical trials.

scholarly journals Assessing the impact on pharmacists’ time by introducing a technician screening process for clinical trial prescriptions

2021 ◽  
Vol 29 (Supplement_1) ◽  
pp. i46-i47
Author(s):  
D Mistry ◽  
S Awan ◽  
E Lundy ◽  
C Bedford ◽  
H Thorp ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Clinical Trials ◽  
Data Collection ◽  
Hospital Pharmacy ◽  
Good Practice ◽  
Advisory Group ◽  
Service Improvement ◽  
Data Collection Tool ◽  
Patient Counselling ◽  
The Impact

Abstract Introduction Various national guidance from the Lord Carter 2016 report to the NHS Long term plan have emphasised the need to transform traditional hospital pharmacy and make work streams more efficient.[1] A clinical trials pharmacist has historically validated clinical trial medicines. Whilst this is good practice for non-chemotherapy prescriptions, it is not a requirement of the Clinical Trial Regulations.[2] Interruption to validate trial prescriptions can have a negative impact on pharmacists’ duty and consequently patient outcomes. With limited data available, this issue has been highlighted by anecdotal evidence. Due to the often complex requirements associated with trials, the research team are responsible for assessing the suitability of treatment. This includes checking interactions with concomitant medication, reviewing blood results and patient counselling. The clinical aspect of the pharmacist validation is therefore removed, allowing technicians to be involved in the screening of suitable prescriptions. Much is written on technicians extending their roles in the clinical setting, but this service improvement focuses on enhancing their role within the pharmacy clinical trials department. Aim To evaluate the amount of pharmacists’ time saved by the introduction of technician screening of clinical trial prescriptions. Method A risk-based proforma was created and used by a pharmacist to assess clinical trial prescriptions for the suitability of screening by a Band 7 technician. Only prescriptions with pre-printed doses, no aseptic preparation or additional medicines, were approved for technician screening. The process of screening therefore only involves the checking of patient and prescriber details, allergy status and possibly a medication randomisation. The technicians under-went an in-house training including the screening of prescriptions under pharmacist supervision. A quantitative data collection tool was used to review the screening / validation of all nonchemotherapy clinical trial prescriptions received at two sites over a two-week period in September 2020. The data collection tool was piloted and all data was analysed using Microsoft Excel. Results A total of 89 prescriptions were received. 56 (63%) were eligible for technician screening, of which a suitable technician validated 50%. Across both sites a total time of 360 minutes were spent validating/screening prescriptions including solving prescription related issues. Combining the time taken by a pharmacist to return from a clinical area and screening time consequently saved a total of 227 minutes of pharmacists’ time. Conclusion Distributing the workload amongst trained staff saves pharmacist’s time, which can be utilised on clinical and complex tasks. This does not eliminate the requirement of a pharmacist to validate prescriptions however; it reduces the frequency and streamlines the service. Further data collection is required to analyse the direct impact on patients’ and any changes in the number of reported errors. A limitation to the study is the lack of data prior to implementation as a comparator. Additionally, during data collection there were no suitable technicians available at one site due to the Covid-19 pandemic, resulting in only 50% of eligible prescriptions being screened by a technician. Ultimately, this does not change the outcome; enhancing technician’s roles allows pharmacists’ time to be used more efficiently. References 1. Royal Pharmaceutical Society. Shaping Pharmacy for the future. Hospital Pharmacy: A briefing for members in England. 2017. Available at: https://www.rpharms.com/Portals/0/Hospital%20pharmacy%20briefing%20-%20final.pdf [Accessed: 11/10/20] 2. National Pharmacy Clinical Trials Advisory Group. Professional Guidance on Pharmacy Services for Clinical Trials v2.1. 2019. Available at: https://www.rpharms.com/Portals/0/RPS%20document%20library/Open%20access/Hospital%20Pharmacy%20Hub/Practice_Guidance_on_Pharmacy_Services_for_Clinical_Trials_v2.1.pdf?ver=2020-09-18-095937-733 [Accessed: 09/10/20]

scholarly journals Utilization of a Clinical Trial Management System for the Whole Clinical Trial Process as an Integrated Database: System Development (Preprint)

2017 ◽  
Author(s):  
Yu Rang Park ◽  
Young Jo Yoon ◽  
HaYeong Koo ◽  
Soyoung Yoo ◽  
Chang-Min Choi ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Clinical Trials ◽  
Management System ◽  
Medical Center ◽  
Academic Medical Center ◽  
Trial Management ◽  
Privacy And Security ◽  
Academic Medical ◽  
Asan Medical ◽  
Clinical Trial Management

BACKGROUND Clinical trials pose potential risks in both communications and management due to the various stakeholders involved when performing clinical trials. The academic medical center has a responsibility and obligation to conduct and manage clinical trials while maintaining a sufficiently high level of quality, therefore it is necessary to build an information technology system to support standardized clinical trial processes and comply with relevant regulations. OBJECTIVE The objective of the study was to address the challenges identified while performing clinical trials at an academic medical center, Asan Medical Center (AMC) in Korea, by developing and utilizing a clinical trial management system (CTMS) that complies with standardized processes from multiple departments or units, controlled vocabularies, security, and privacy regulations. METHODS This study describes the methods, considerations, and recommendations for the development and utilization of the CTMS as a consolidated research database in an academic medical center. A task force was formed to define and standardize the clinical trial performance process at the site level. On the basis of the agreed standardized process, the CTMS was designed and developed as an all-in-one system complying with privacy and security regulations. RESULTS In this study, the processes and standard mapped vocabularies of a clinical trial were established at the academic medical center. On the basis of these processes and vocabularies, a CTMS was built which interfaces with the existing trial systems such as the electronic institutional review board health information system, enterprise resource planning, and the barcode system. To protect patient data, the CTMS implements data governance and access rules, and excludes 21 personal health identifiers according to the Health Insurance Portability and Accountability Act (HIPAA) privacy rule and Korean privacy laws. Since December 2014, the CTMS has been successfully implemented and used by 881 internal and external users for managing 11,645 studies and 146,943 subjects. CONCLUSIONS The CTMS was introduced in the Asan Medical Center to manage the large amounts of data involved with clinical trial operations. Inter- and intraunit control of data and resources can be easily conducted through the CTMS system. To our knowledge, this is the first CTMS developed in-house at an academic medical center side which can enhance the efficiency of clinical trial management in compliance with privacy and security laws.

scholarly journals CAR T-cell therapy for B-cell lymphomas: clinical trial results of available products

2019 ◽  
Vol 10 ◽  
pp. 204062071984158 ◽  
Author(s):  
Julio C. Chavez ◽  
Christina Bachmeier ◽  
Mohamed A. Kharfan-Dabaja
Keyword(s):  
Clinical Trial ◽  
Clinical Trials ◽  
T Cell ◽  
B Cell ◽  
T Cell Therapy ◽  
Car T Cell ◽  
Car T Cell Therapy ◽  
Car T ◽  
Multicenter Clinical Trials ◽  
Clinical Trial Results

Adoptive cellular immunotherapy with chimeric antigen receptor (CAR) T cell has changed the treatment landscape of B-cell non-Hodgkin’s lymphoma (NHL), especially for aggressive B-cell lymphomas. Single-center and multicenter clinical trials with anti-CD19 CAR T-cell therapy have shown great activity and long-term remissions in poor-risk diffuse large B-cell lymphoma (DLBCL) when no other effective treatment options are available. Two CAR T-cell products [axicabtagene ciloleucel (axi-cel) and tisagenlecleucel] have obtained US Food and Drug Administration approval for the treatment of refractory DLBCL after two lines of therapy. A third product, liso-cel, is currently being evaluated in clinical trials and preliminary results appear very promising. CAR T-cell-related toxicity with cytokine-release syndrome and neurotoxicity remain important potential complications of this therapy. Here, we review the s biology, structure, clinical trial results and toxicity of two commercially approved CAR T-cell products and others currently being studied in multicenter clinical trials in B-cell NHLs.

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

2018 ◽  
Vol 26 (2) ◽  
pp. 86
Author(s):  
Jin-Sol Park ◽  
Seol Ju Moon ◽  
Ji-Hyoung Lee ◽  
Ji-Young Jeon ◽  
Kyungho Jang ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Clinical Trials ◽  
Management System ◽  
Future Clinical Trial ◽  
Trial Management ◽  
Clinical Trial Management

Planning the Size of Clinical Trials with Allowance for Patient Noncompliance

1990 ◽  
Vol 29 (03) ◽  
pp. 243-246 ◽  
Author(s):  
M. A. A. Moussa
Keyword(s):  
Clinical Trial ◽  
Clinical Trials ◽  
Sample Size ◽  
Event Rate ◽  
Survival Functions ◽  
Time Intervals ◽  
Patient Noncompliance ◽  
Event Rates ◽  
Larger Sample

AbstractVarious approaches are considered for adjustment of clinical trial size for patient noncompliance. Such approaches either model the effect of noncompliance through comparison of two survival distributions or two simple proportions. Models that allow for variation of noncompliance and event rates between time intervals are also considered. The approach that models the noncompliance adjustment on the basis of survival functions is conservative and hence requires larger sample size. The model to be selected for noncompliance adjustment depends upon available estimates of noncompliance and event rate patterns.

Sign in / Sign up

Export Citation Format

Share Document