Using a Quality Management System and Risk-based Approach in Observational Studies to Obtain Robust Real-World Evidence.
The results of observational studies using real-world data, known as real-world evidence, have gradually started to be used in drug development and decision-making by policymakers. A good quality management system—a comprehensive system of process, data, and documentation to ensure quality—is import...
| Publicado en: | Therapeutic Innovation & Regulatory Science Vol. 58; no. 6; pp. 1006 - 1014 |
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| Autores principales: | , , , , , , , , , , , , , , , , , , , |
| Formato: | research tables/charts Journal Article |
| Publicado: |
Springer Nature
Nov2024
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| Acceso en línea: | Ver este registro en EBSCOhost |
| fields | @attributes: recordID: 1 pdfLink: plink: https://search.ebscohost.com/login.aspx?direct=true&db=ccm&AN=180626102&site=ehost-live header: @attributes: shortDbName: ccm uiTerm: 180626102 longDbName: CINAHL Complete uiTag: AN controlInfo: bkinfo: dissinfo: jinfo: jid: 21684790 FUHO jtl: Therapeutic Innovation & Regulatory Science issn: 21684790 maglogo: N pubinfo: dt: Nov2024 vid: 58 iid: 6 pid: 237 pub: Springer Nature place: New York, New York artinfo: ui: 180626102 179410402 180626102 180626102 10.1007/s43441-024-00695-6 180626102 ppf: 1006 ppct: 8 formats: tig: atl: Using a Quality Management System and Risk-based Approach in Observational Studies to Obtain Robust Real-World Evidence. aug: au: Tanoshima, Reo Inagaki, Naoko Nitta, Manabu Sue, Soichiro Shimizu, Sayuri Haze, Tatsuya Senuki, Kotaro Sano, Chihiro Takase, Hajime Kaneko, Makoto Nozaki, Akito Okada, Kozo Ohyama, Kohei Kawaguchi, Atsushi Kobayashi, Yusuke Oi, Hideki Maeda, Shin Yano, Yuichiro Kumagai, Yuji Miyagi, Etsuko affil: https://ror.org/010hfy465 YCU Center for Novel and Exploratory Clinical Trials, Yokohama City University Hospital, 1-1- 1 Fukuura, Yokohama, Kanagawa, Japan sug: subj: Data Management Data Quality Nonexperimental Studies Documentation Risk Assessment Human Multidisciplinary Care Team Decision Making Strategic Planning Program Implementation Funding Source ab: The results of observational studies using real-world data, known as real-world evidence, have gradually started to be used in drug development and decision-making by policymakers. A good quality management system—a comprehensive system of process, data, and documentation to ensure quality—is important in obtaining real-world evidence. A risk-based approach is a common quality management system used in interventional studies. We used a quality management system and risk-based approach in an observational study on a designated intractable disease. Our multidisciplinary team assessed the risks of the real-world data study comprehensively and systematically. When using real-world data and evidence to support regulatory decisions, both the quality of the database and the validity of the outcome are important. We followed the seven steps of the risk-based approach for both database selection and research planning. We scored the risk of two candidate databases and chose the Japanese National Database of designated intractable diseases for this study. We also conducted a quantitative assessment of risks associated with research planning. After prioritizing the risks, we revised the research plan and outcomes to reflect the risk-based approach. We concluded that implementing a risk-based approach is feasible for an observational study using real-world data. Evaluating both database selection and research planning is important. A risk-based approach can be essential to obtain robust real-world evidence. pubtype: Academic Journal doctype: research tables/charts Journal Article ougenre: Article language: English refInfo: holdings: @attributes: islocal: N |
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