Creating Evidence From Real World Patient Digital Data
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Creating Evidence from Real World Patient Digital Data
Topic Editor Dr. Eric Daza is Senior Statistician at Clarify Health Solutions. All other Topic Editors declare no competing interests with regards to the Research Topic subject.
Real-world Data and Real-World Evidence in Regulatory Decision Making
Author: Council for International Organizations of Medical Sciences
language: en
Publisher: Council for International Organizations of Medical Sciences
Release Date: 2024-05-29
In recent years, many medicines regulatory agencies have expressed increased willingness to consider real-world evidence (RWE), that derives from the review and/or analysis of real-world data (RWD), to support claims of efficacy or effectiveness as well as of safety. This increased willingness is changing the regulatory environment in which RWE is generated and used. This consensus report aims to describe the potential use of RWE for decision making; RWD and data sources; key scientific considerations in the generation of RWE; and ethical and governance issues in using RWD. The intended audience for this report includes medicinal product regulators, healthcare payers, health care and medicinal products industries, researchers, bioethicists, patients and health care professionals. This report was developed to inform discussions about the use of RWD and RWE for regulatory and health care decision making, including decisions to make a product available for use (authorisation), to cover the costs of its use (reimbursement), and to use a product for a particular patient (clinical use). This report reflects the opinions of the Council for International Organizations of Medical Sciences (CIOMS) Working Group XIII on Real-world data and real-world evidence in regulatory decision making, and it was finalised after considering comments received during a public consultation.
Patient involvement in the development, regulation and safe use of medicines
Author: Council for International Organizations of Medical Sciences (CIOMS)
language: en
Publisher: Council for International Organizations of Medical Sciences
Release Date: 2022-09-05
This report describes the importance of systematically involving patients throughout a medicine’s life – from its early development through the regulatory process to ongoing monitoring and safe use in everyday healthcare. It provides a comprehensive overview of the current knowledge about the benefits of patient involvement and existing initiatives, gives many examples and recommendations, and addresses the remaining challenges and practice gaps. The report will prompt readers to implement its best practice recommendations according to how well they fit in with their organizational and national needs. The report combines the experience and expertise of the CIOMS Working Group XI on Patient involvement in the development, regulation and safe use of medicines. It also incorporates views gathered from an open meeting in Switzerland and a workshop in Uganda, which both brought together members of the public, patient organization representatives, regulators, drug development experts, industry, academia, health professionals and other related stakeholders. The report was finalized following a public consultation. CIOMS is an international, non-governmental, non-profit organization with the mission to advance public health through guidance on health research and policy including ethics, medical product development and pharmacovigilance. https://doi.org/10.56759/iiew8982