The Asia Cornea Society Infectious Keratitis Study (ACSIKS) is a three-year, multi-centre, prospective and observational study of infectious keratitis cases in 30 sites spanning eight different Asian countries: India, China, Japan, South Korea, Taiwan, Thailand, Philippines and Singapore. The total number of recruited subjects exceeded 6,500 and the first phase of the project has been successfully completed.
The SCRI Data Management Team performs remote monitoring for the large-scale ACSIKS study by examining a variety of datasets to uncover hidden data patterns, correlations, and trends including data entry preferences and other useful operational information. These trial analytical findings can lead to more effective ways of identifying and securing data quality and improved operational efficiency.
The Data Management Team developed a customised database for the ACSIKS Study that is simple and user-friendly enough to allow all 30 sites to enter diverse study data with ease. It also programmes automated system checks to ensure data consistency and streamline data cleaning, and integrates interactive query management for effective communication with the sites to ensure the quality and integrity of data are closely monitored in a central monitoring system. In addition, the Team generates monthly data metrics to the Project Management Team for project progress updates.
The Data Management Team also addressed the PI’s needs to generate special data listings and reports for presentation at the Asia Cornea Society Conference. The Data Management Team works closely with the Biostatisticians to effectively merge multiple data tables to produce clinically relevant datasets.
AHCC06 is an Investigator-initiated, open-label, randomised-controlled study that compares the outcomes of two established treatments in patients with locally-advanced hepatocellular carcinoma (HCC), namely SIR Spheres® microspheres and Sorafenib. The Trial is jointly funded by NMRC and SIRTeX, a medical device company. The primary objective of this Trial is to determine which of the two treatments confers better overall survival for HCC patients.
The AHCC06 Trial involves 29 renowned medical centres across the Asia Pacific region. To date, the Trial has successfully completed two independent interim analyses and is on track to meet the enrollment timelines.
SCRI’s Project Management provides the coordination and dedicated support for the AHCC06 Study in day-to-day trial operations. With its meticulous oversight of the trial data reporting and query resolution, the Team is ready to initiate and implement improvement strategies where needed in the event of operational challenges.
The Project Management Team actively engages in planning and coordinating important trial milestones. Two such occasions in 2014 were the Investigators’ Meetings in Taiwan and Singapore – which were valuable platforms for open discussion of the AHCC06 Trial progress, issues and their solutions.
The Project Management Team regularly presents Sirtex with key project updates and collaborates closely with Sirtex to facilitate the conduct of the Trial. An encouraging development in 2014 was Sirtex’s additional funding of up to S$1.9 million provided for AHCC06, aimed at enhancing trial quality and facilitating subject recruitment.
The device trial, SINGA-PACLI, is the first Investigator-initiated, randomised-controlled trial focusing on Asians suffering from Critical Limb Ischaemia (CLI). The Trial compares drug-eluting balloons percutaneous transluminal angioplasty (DEB-PTA) with conventional balloons (CB-PTA) in below-the-knee (BTK) arterial lesions.
The Study target is to recruit 136 subjects from two Singapore sites: the Singapore General Hospital and TTSH. Being a double-blind randomised medical device trial, the Study procedure and monitoring presented complex challenges.
Given the complexity of the Trial, the SCRI Team’s investigational product management expertise was called on in the establishment of the feasibility study procedures. In addition, SCRI’s CRAs designated blinded and unblinded study roles to ensure data collected is protected and verified. The CRAs also ensure that adverse events are correctly documented and reported promptly to regulatory authorities and study investigators.
Cancers of the breast, lung, colon, prostate and ovary remain a highly significant cause of morbidity and mortality worldwide. One potentially promising avenue for the development of new anti-cancer agents is stimulating the immune system to specifically recognise and eradicate targeted cancer cells.
The MUC-1 Study is a single-site, First-in-Human clinical trial in oncology which aims to assess the safety and benefit of the MUC-1 vector vaccine and to identify a tolerable, immunologically active dose level. This unique MUC-1 vector vaccine is provided by MicroVAX, LLC, a biotechnology company located in Manassas, Virginia, USA.
The Study PI is Dr Toh Han Chong, Senior Consultant and Deputy Director at NCCS, and SCRI was invited by the PI and MicroVAX to participate in this First-in-Human trial as the Study Sponsor.
As Study Sponsor, SCRI is responsible for ensuring sufficient resources to initiate, manage and deliver the research as proposed. SCRI also worked with the PI and MicroVAX to develop the study protocol and to prepare the site for the study initiation.
SCRI provided oversight of safety monitoring, quality control and quality assurance throughout the Study to ensure the data collected was accurate and of quality standard. SCRI also provided CRO management via close supervision to ensure that overall conduct of the Study was in compliance with the approved study protocol, regulatory requirements and good clinical practice.
With able support from SCRI, MUC-1 made timely progress during the year. As Sponsor, SCRI proactively identified potential study risks and provided mitigation actions. Moreover, SCRI ensured that any protocol deviations were reported promptly to the Ethics and Regulatory authorities with appropriate corrective and preventive actions. SCRI also undertook regulatory submissions to the Health Sciences Authority, obtained regulatory approvals, acted as the IP importer to ensure the appropriate delivery and storage conditions for the IP on site.
Adult Dengue Platelet Study (ADEPT) is the first local Investigator-initiated, multi-centred, randomised-controlled trial on prophylactic platelet transfusion for dengue patients with severe thrombocytopenia. It compares patients given supportive care and platelet transfusion versus supportive care alone. The Study aims to determine whether platelet transfusion should be given prophylactically to prevent bleeding in dengue patients. The findings are vital to support good clinical practices not restricted to local practices but globally.
ADEPT has enrolled 372 patients since Apr 2010 and is in the final stages of study analysis for the Clinical Study Report. ADEPT has been supported by SCRI’s Project Management, Research Monitoring, Biostatistics and Research Informatics Departments. Year 2014 was crucial for ADEPT as it was the last recruitment year. Despite facing challenging recruitment delays at first – with more than 141 subjects required by the end of 2014, both Singapore and Malaysian study sites worked hard together to successfully achieve its target a month ahead of schedule.
SCRI’s Project Management Team provided robust support with the recruitment through proactive reviews of the prescreening and screen-failure data. Through close follow-ups, regular sharing of sites’ best practices with study teams during monthly project meetings and consistent weekly updates of recruitment status, the Team was able to help identify potential recruitment issues.
Another challenge was to resolve more than 4,500 data queries within nine months, so that clean data could be analysed for the final Clinical Study Report before the study grant closure. This milestone was successfully achieved on time as SCRI’s Team played a close facilitative role in addition to Tan Tock Seng Hospital (TTSH) strong administrative support from clinical investigators. SCRI’s efforts leading up to this successful data cleaning included implementing training on the completion of case report forms, data query tracking and active follow-up.