This workshop, held as the first DIA Japan event, now celebrates its 25th anniversary. Throughout this first quarter century, we actively incorporated the expertise of local and international speakers and patients to address the needs of the current era and the challenges of the future in response to so much rapid change in the clinical development environment. We continue to articulate what skill sets the clinical data manager (CDM) needs and what the CDM should do in our interactions with others in industry, government, and academia. The impact of COVID-19 on clinical sites, and today’s urgent need for flexible decision-making and other innovative methods, has given us a new opportunity to realize the importance of this cross-role, purpose-oriented collaboration and communication.
Innovation continues to accelerate in data management practice: for example, the diversification of data sources (including real-world data [RWD], patient health records [PHRs], etc.), utilization of the advanced digital technologies, digital therapeutics (DTx), and decentralized clinical trials, and increased the importance of clinical data management in academic research and registry utilization. Regulatory innovations and other trends also remain active. The August 2020 Revision of the Ministerial Ordinance on Good Clinical Practice for Medical Products provides a reference guide to ensure smooth clinical trial implementation. The New Ethical Guidelines on Life Science and Medical Research for Human Beings were issued in March 2021 to ensure that patient protection and reliable science remain paramount. PMDA also issued Basic Concepts on Use of Registries in Approval Application, which is expected to promote utilization of RWD acquired under actual medical conditions, in March 2021. The June 2021 ICH Reflection paper Proposed ICH Guideline Work to Advance Patient-Focused Drug Development is driving discussions about implementation around the world.
In this 25th anniversary 2022 workshop, we hope to improve the quality of both CDM and clinical research through shared discussions among industry, government, academia, patients, and related stakeholders on the value and future of clinical development data, with people in need of new treatment as our common goal.
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Keisuke Utsumi Head, Development Global Medical, Japan Development Division
GlaxoSmithKline K.K., Japan
Misato Kuwagaki, MS Associate Director, Data Sciences
Eli Lilly Japan K.K., Japan
Yumiko Asami Chapter Head of Clinical Data Science
Boehringer Ingelheim, Japan
Yukikazu Hayashi Assistant Head of Clinical Development
A2 Healthcare Corporation, Japan
Michiko Ishida Office of Non-clinicaland Clinical Compliance
Pharmaceuticals and Medical Devices Agency (PMDA), Japan
Mika Maeda Lecturer, Section for Human Research Protections, Kitasato University Hospital
School of Pharmacy, Kitasato University, Japan
Yasuhiro Matsumoto Manager, Data Management Group, Data Science, Development
Astellas Pharma Inc., Japan
Tempei Miyaji, MSc Project Assistant Professor, Department of Clinical Trial Data Management
The University of Tokyo, Japan
Kotaro Sato Senior Data Team Lead, Clinical Data Management, Data Sciences
IQVIA Services Japan K.K., Japan
Yuko Yamahara Clinical Translational Research Center
Kobe University Hospital, Japan
Mika Ogasawara Data Quality Lead, Biometrics and Data Management
Pfizer R&D Japan G.K., Japan
Yoko Hattori Project Assistant Professor
Chiba University Hospital Clinical Research Center, Japan
Kyoko Minamoto Medical Technologist
National Cancer Center, Japan
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