2024 Japan Academic Workshop Program
Japan Academic Workshop Presentations
In 2022, the International Council on the Harmonization of Technical Requirements for Pharmaceuticals for Human Use (ICH) M11 Working Group published their draft guideline for a Clinical Electronic Structured Harmonized Protocol (CeSHarp) with a template and technical specifications. Two of the core principles of the template included “defining content for electronic exchange” and “design for content reuse.” Design principles for the technical specifications were notable for identifying the need for “developing a model based on specification.” These guidelines may be the catalyst to align many ongoing efforts in an impactful way.
The ongoing collaboration between CDISC and TransCelerate using an open-source approach to develop a Unified Study Definitions Model (USDM) will issue its third release in April. The USDM is delivered as a data model (i.e., names, attributes, cardinality, relationships) with controlled terminology definitions, an implementation guide, and a reference architecture with application programming interface (API) specifications. The scope of the USDM includes study definition information found in protocol documents such as general study information—phase, therapeutic area, indication—study design, schedule of activities and assessments, workflow and eligibility, and biomedical concepts to specify protocol-required data.
In June, 2023, CDISC and Vulcan, an HL7 FHIR Accelerator, jointly announced via a press release their intention to utilize the USDM to accelerate the development of the content model envisioned as part of the ICH M11 project. This effort is supported by a Joint Leadership Forum that includes CDISC, ICH, TransCelerate, and the Vulcan Accelerator. This presentation will focus on the “So What?” by discussing the real opportunity to bring together the collective know-how and the previously established building blocks. This is a classic example of innovation through collaboration and a path to true digitalization of the clinical research. It is an opportunity to go digital first by intent. The potential impact on relevant stakeholders will be presented.
At last year’s presentation, the new data management and sharing policy in the United States had just recently gone into effect as had requirements for monthly recruitment in clinical trials funded by the National Institute on Aging. These initial years of both policies have uncovered new use cases for CDISC, particularly CDASH and SDTM standards ant associated controlled terminology. At the same time the desire for Registry Real-World Data (RDW) has only increased. We present institutional uptick in interest in SDTM and CDASH for clinical studies, as well as a synthesis of multiple evaluations of SDTM for the representation of RWD from clinical registries. Together with early results from the AnCillary Studies to Evaluate Real-World Data Quality program these signal increased use cases for and benefit from these standards.
Since 2011, nine Japanese clinical Associations have established and maintained the minimum standardization Item set for non-communicable diseases such as diabetes, hypertension, dyslipidemia, and chronic kidney disease for use in digital health. Here I introduce about some use cases. First, we established recommended configuration for Personal Health Record, with thresholds for risk staratification, values for alert, and reminder periods for each item by reflecting international clinical guidelines. Some of PHR application works on this. In addition, we developped risk stratification logic based on the PHR cofiguration to use digital health in rural area of developing countries, to provide a packaged service of health checkups and telemedicine in some of Asian and African countries. The item set has also been adopted for the Japanese nationwide healthcare network infrastructure currently being constructed by the Japanese government. We are also working with CDISC to promote alignment with the Standard Data Tabulation Model (v3.4). Determining and disseminating such items will improve data accuracy and missing values, and will contribute to expand collaboration between researchers in Japan and CDISC.
The Data Sharing Policy of the US NIH has been revised in conjunction with the progress of the GREI project, and Vivli is one of the seven repositories partnered with the NIH, providing a data sharing mechanism compliant with NIH's Policy. Vivli is also involved in reviewing the NIH's Common Data Elements in collaboration with CDISC. Additionally, we have commenced collaborative research with Duke University, the originator of the term ARO. We will have a presentation on the progress and changes in the surrounding environment since last year's announcement.
Since 2015, NHO Nagoya Medical Center has implemented CDISC standards in investigator-initiated study. As of 2024, these standards are employed in 9 investigator-initiated studies, 25 intervention studies, and 12 observational studies. The adoption of CDISC standards has unified terminology across trials through Controlled Terminology and standardized database structures and variable names using SDTM. This initiative has also standardized CRFs and operational processes, facilitated smoother inter-departmental communication, and promoted the secondary use of data. In this presentation, we will showcase case studies from NHO Nagoya Medical Center, highlighting achievements made possible by leveraging CDISC standards within the constraints of an Academic Research Organization (ARO).
Data managers may imagine that the introduction of CDISC standards will increase their workload. In fact, they do not think that their workload will be significantly reduced. However, there are benefits for them as well. There are also huge benefits for clinical research as a whole, and when viewed as a worldwide grouping of clinical research. In Japan, the Ministry of Health, Labor and Welfare is promoting "work style reform." In particular, a new work style reform system for doctors was applied in April of this year, and an upper limit on overtime work was established. As work style reform for doctors in charge of clinical research is implemented, it is difficult to reduce medical care, and they are forced to reduce the time they can devote to clinical research. I will give a presentation on the benefits of introducing CDISC, including the reason why data managers are employed.
We have established an "SDTM subteam for CDISC beginners" within the CDISC Japan User Group(CJUG) SDTM team, starting in December 2022. The primary purpose is to contribute to human resource development and promote CDISC implementation in AROs through knowledge and skills on CDISC by practicing SDTM data set creation through a mock protocol. We have completed EDC construction and the creation of the Trial Design Model. We are considering creating materials, including flowcharts, specific tasks, and templates at each stage for beginners unfamiliar with the workflow that will lead to the creation of SDTM datasets. Our team is gaining experience implementing CDISC standards in Japanese academia and creating materials that make it easier for team members to transfer their knowledge and skills to their respective organizations. In this workshop, we will introduce the roadmap of our team activities along with the achievements to date.
Through participation in CJUG activities, academic data managers (DMs) acquired foundational knowledge of CDISC standards. This enabled them to collaborate early with the sponsoring companies and share responsibilities in data management for investigator-initiated trials. Consequently, they contributed significantly to the preparation for CDISC compliance. This presentation reports on the details of these efforts.
This presentation will summarise the major European initiatives, mostly public private partnerships involving academia, the pharmaceutical industry, and other stakeholders, to develop the use cases, information architectures and grow the market of commercial products that use hospital electronic health record data to improve the efficiency of clinical trial design and conduct. The talk will cover projects such as EHR4CR, EHR2EDC, EU Pearl, c4c and EHDEN, which have each focused on different points in the clinical trial life cycle or provided a data platform for large scale observational studies. The talk will conclude with the exciting outlook in Europe through the forthcoming European Health Data Space, and its prospects for scaling up the availability of large populations of patient summaries that could be queried for clinical trial purposes. The xShare project is now developing specifications to help enhance that opportunity.
Academic researchers gain many benefits from the use of data standards such as those maintained by CDISC. These benefits include enhanced data quality and reliability, improved efficiency in data collection and analysis pipelines, and increased data sharing and data reuse capabilities both within-group and with external collaborators. The Infectious Diseases Data Observatory (IDDO) has utilized the SDTM standard over the last seven years to harmonize and standardize academic clinical trial datasets to facilitate secondary data reuse and generate new evidence to improve patient outcomes. IDDO also facilitates the use of good data standards at the beginning of the data lifecycle via CDISC-annotated CRF templates that can be used by the research community to ensure high quality data and to enable data sharing and interoperability from the very start of a trial. This presentation covers the learnings from IDDO’s use of CDISC standards and the benefits to the academic research community.