Visions for a JACIE Quality Management System 4.0
Standard
Visions for a JACIE Quality Management System 4.0. / Snowden, John A; McGrath, Eoin; Orchard, Kim; Kröger, Nicolaus; Sureda, Anna; Gratwohl, Alois.
In: BONE MARROW TRANSPL, Vol. 56, No. 12, 12.2021, p. 2876-2881.Research output: SCORING: Contribution to journal › SCORING: Review article › Research
Harvard
APA
Vancouver
Bibtex
}
RIS
TY - JOUR
T1 - Visions for a JACIE Quality Management System 4.0
AU - Snowden, John A
AU - McGrath, Eoin
AU - Orchard, Kim
AU - Kröger, Nicolaus
AU - Sureda, Anna
AU - Gratwohl, Alois
N1 - © 2021. The Author(s).
PY - 2021/12
Y1 - 2021/12
N2 - Quality management has been part of hematopoietic stem cell transplantation (HSCT) from the very beginning. It evolved step-wise from open data exchange up to the introduction of the FACT/JACIE-based quality management system (QMS) 2 decades ago. This formal step has eased cooperation, and improved outcome for patients. Today's expansion of cellular and targeted therapies and new drugs, and the regulatory requirements for advanced therapeutic medicinal products have touched the limits of the current system. Based on the Medicine 4.0 concept, the next step should integrate novel views of QMS. The old definition "Best Quality Transplant" will be replaced by "Optimal Treatment," and encompass the entire health care journey. "Best outcome" will refer to overall survival, quality of life and costs, with or without HSCT, and will be compatible with all requirements by competent authorities. Decisions will be based on high-level evidence, supported by real-time digitized data collection, data analysis, incorporated into artificial-intelligence systems. To reach this goal, EBMT/JACIE will be challenged to start the process by further fostering harmonization within and between organizations at institutional, national, and European levels. Acceleration in information technology and modifications to working practices during the pandemic should facilitate this development to the next stage.
AB - Quality management has been part of hematopoietic stem cell transplantation (HSCT) from the very beginning. It evolved step-wise from open data exchange up to the introduction of the FACT/JACIE-based quality management system (QMS) 2 decades ago. This formal step has eased cooperation, and improved outcome for patients. Today's expansion of cellular and targeted therapies and new drugs, and the regulatory requirements for advanced therapeutic medicinal products have touched the limits of the current system. Based on the Medicine 4.0 concept, the next step should integrate novel views of QMS. The old definition "Best Quality Transplant" will be replaced by "Optimal Treatment," and encompass the entire health care journey. "Best outcome" will refer to overall survival, quality of life and costs, with or without HSCT, and will be compatible with all requirements by competent authorities. Decisions will be based on high-level evidence, supported by real-time digitized data collection, data analysis, incorporated into artificial-intelligence systems. To reach this goal, EBMT/JACIE will be challenged to start the process by further fostering harmonization within and between organizations at institutional, national, and European levels. Acceleration in information technology and modifications to working practices during the pandemic should facilitate this development to the next stage.
U2 - 10.1038/s41409-021-01467-8
DO - 10.1038/s41409-021-01467-8
M3 - SCORING: Review article
C2 - 34588628
VL - 56
SP - 2876
EP - 2881
JO - BONE MARROW TRANSPL
JF - BONE MARROW TRANSPL
SN - 0268-3369
IS - 12
ER -
