Creating Evidence From Real World Patient Digital Data

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Creating Evidence From Real World Patient Digital Data

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Author : Jane Nikles
language : en
Publisher: Frontiers Media SA
Release Date : 2021-04-07

Creating Evidence From Real World Patient Digital Data written by Jane Nikles and has been published by Frontiers Media SA this book supported file pdf, txt, epub, kindle and other format this book has been release on 2021-04-07 with Science categories.

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 Evidence In Drug Development And Evaluation

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Author : Harry Yang
language : en
Publisher: CRC Press
Release Date : 2021-01-11

Real World Evidence In Drug Development And Evaluation written by Harry Yang and has been published by CRC Press this book supported file pdf, txt, epub, kindle and other format this book has been release on 2021-01-11 with Mathematics categories.

Real-world evidence (RWE) has been at the forefront of pharmaceutical innovations. It plays an important role in transforming drug development from a process aimed at meeting regulatory expectations to an operating model that leverages data from disparate sources to aid business, regulatory, and healthcare decision making. Despite its many benefits, there is no single book systematically covering the latest development in the field. Written specifically for pharmaceutical practitioners, Real-World Evidence in Drug Development and Evaluation, presents a wide range of RWE applications throughout the lifecycle of drug product development. With contributions from experienced researchers in the pharmaceutical industry, the book discusses at length RWE opportunities, challenges, and solutions. Features Provides the first book and a single source of information on RWE in drug development Covers a broad array of topics on outcomes- and value-based RWE assessments Demonstrates proper Bayesian application and causal inference for real-world data (RWD) Presents real-world use cases to illustrate the use of advanced analytics and statistical methods to generate insights Offers a balanced discussion of practical RWE issues at hand and technical solutions suitable for practitioners with limited data science expertise

Registries For Evaluating Patient Outcomes

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Author : Richard E. Gliklich
language : en
Publisher:
Release Date : 2014

Registries For Evaluating Patient Outcomes written by Richard E. Gliklich and has been published by this book supported file pdf, txt, epub, kindle and other format this book has been release on 2014 with Diseases categories.

Real World Data And Real World Evidence In Regulatory Decision Making

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Author : Council for International Organizations of Medical Sciences
language : en
Publisher: Council for International Organizations of Medical Sciences
Release Date : 2024-05-29

Real World Data And Real World Evidence In Regulatory Decision Making written by Council for International Organizations of Medical Sciences and has been published by Council for International Organizations of Medical Sciences this book supported file pdf, txt, epub, kindle and other format this book has been release on 2024-05-29 with Science categories.

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.

Artificial Intelligence In Healthcare

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Author : Adam Bohr
language : en
Publisher: Academic Press
Release Date : 2020-06-21

Artificial Intelligence In Healthcare written by Adam Bohr and has been published by Academic Press this book supported file pdf, txt, epub, kindle and other format this book has been release on 2020-06-21 with Computers categories.

Artificial Intelligence (AI) in Healthcare is more than a comprehensive introduction to artificial intelligence as a tool in the generation and analysis of healthcare data. The book is split into two sections where the first section describes the current healthcare challenges and the rise of AI in this arena. The ten following chapters are written by specialists in each area, covering the whole healthcare ecosystem. First, the AI applications in drug design and drug development are presented followed by its applications in the field of cancer diagnostics, treatment and medical imaging. Subsequently, the application of AI in medical devices and surgery are covered as well as remote patient monitoring. Finally, the book dives into the topics of security, privacy, information sharing, health insurances and legal aspects of AI in healthcare. - Highlights different data techniques in healthcare data analysis, including machine learning and data mining - Illustrates different applications and challenges across the design, implementation and management of intelligent systems and healthcare data networks - Includes applications and case studies across all areas of AI in healthcare data

Virtual Clinical Trials

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Author : National Academies of Sciences, Engineering, and Medicine
language : en
Publisher: National Academies Press
Release Date : 2019-11-16

Virtual Clinical Trials written by National Academies of Sciences, Engineering, and Medicine and has been published by National Academies Press this book supported file pdf, txt, epub, kindle and other format this book has been release on 2019-11-16 with Medical categories.

Successful drug development relies on accurate and efficient clinical trials to deliver the best and most effective pharmaceuticals and clinical care to patients. However, the current model for clinical trials is outdated, inefficient and costly. Clinical trials are limited by small sample sizes that do not reflect variations among patients in the real world, financial burdens on participants, and slow processes, and these factors contribute to the disconnect between clinical research and clinical practice. On November 28-29, the National Academies of Sciences, Engineering, and Medicine convened a workshop to investigate the current clinical trials system and explore the potential benefits and challenges of implementing virtual clinical trials as an enhanced alternative for the future. This publication summarizes the presentations and discussions from the workshop.

Sharing Clinical Trial Data

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Author : Institute of Medicine
language : en
Publisher: National Academies Press
Release Date : 2015-04-20

Sharing Clinical Trial Data written by Institute of Medicine and has been published by National Academies Press this book supported file pdf, txt, epub, kindle and other format this book has been release on 2015-04-20 with Medical categories.

Data sharing can accelerate new discoveries by avoiding duplicative trials, stimulating new ideas for research, and enabling the maximal scientific knowledge and benefits to be gained from the efforts of clinical trial participants and investigators. At the same time, sharing clinical trial data presents risks, burdens, and challenges. These include the need to protect the privacy and honor the consent of clinical trial participants; safeguard the legitimate economic interests of sponsors; and guard against invalid secondary analyses, which could undermine trust in clinical trials or otherwise harm public health. Sharing Clinical Trial Data presents activities and strategies for the responsible sharing of clinical trial data. With the goal of increasing scientific knowledge to lead to better therapies for patients, this book identifies guiding principles and makes recommendations to maximize the benefits and minimize risks. This report offers guidance on the types of clinical trial data available at different points in the process, the points in the process at which each type of data should be shared, methods for sharing data, what groups should have access to data, and future knowledge and infrastructure needs. Responsible sharing of clinical trial data will allow other investigators to replicate published findings and carry out additional analyses, strengthen the evidence base for regulatory and clinical decisions, and increase the scientific knowledge gained from investments by the funders of clinical trials. The recommendations of Sharing Clinical Trial Data will be useful both now and well into the future as improved sharing of data leads to a stronger evidence base for treatment. This book will be of interest to stakeholders across the spectrum of research-from funders, to researchers, to journals, to physicians, and ultimately, to patients.

Patient Involvement In The Development Regulation And Safe Use Of Medicines

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Author : Council for International Organizations of Medical Sciences (CIOMS)
language : en
Publisher: Council for International Organizations of Medical Sciences
Release Date : 2022-09-05

Patient Involvement In The Development Regulation And Safe Use Of Medicines written by Council for International Organizations of Medical Sciences (CIOMS) and has been published by Council for International Organizations of Medical Sciences this book supported file pdf, txt, epub, kindle and other format this book has been release on 2022-09-05 with Medical categories.

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

Targeted Learning

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Author : Mark J. van der Laan
language : en
Publisher: Springer Science & Business Media
Release Date : 2011-06-17

Targeted Learning written by Mark J. van der Laan and has been published by Springer Science & Business Media this book supported file pdf, txt, epub, kindle and other format this book has been release on 2011-06-17 with Mathematics categories.

The statistics profession is at a unique point in history. The need for valid statistical tools is greater than ever; data sets are massive, often measuring hundreds of thousands of measurements for a single subject. The field is ready to move towards clear objective benchmarks under which tools can be evaluated. Targeted learning allows (1) the full generalization and utilization of cross-validation as an estimator selection tool so that the subjective choices made by humans are now made by the machine, and (2) targeting the fitting of the probability distribution of the data toward the target parameter representing the scientific question of interest. This book is aimed at both statisticians and applied researchers interested in causal inference and general effect estimation for observational and experimental data. Part I is an accessible introduction to super learning and the targeted maximum likelihood estimator, including related concepts necessary to understand and apply these methods. Parts II-IX handle complex data structures and topics applied researchers will immediately recognize from their own research, including time-to-event outcomes, direct and indirect effects, positivity violations, case-control studies, censored data, longitudinal data, and genomic studies.

Insights In Regulatory Science 2021

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Author : Bruno Sepodes
language : en
Publisher: Frontiers Media SA
Release Date : 2022-11-04

Insights In Regulatory Science 2021 written by Bruno Sepodes and has been published by Frontiers Media SA this book supported file pdf, txt, epub, kindle and other format this book has been release on 2022-11-04 with Medical categories.