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Real-World Evidence in the Pharmaceutical Landscape

Author: Sunil Dravida

Publisher: Gatekeeper Press

Published: 2021-12-14

Total Pages: 249

ISBN-13: 1662914091

In Real-World Evidence in the Pharmaceutical Landscape, life science industry experts Sunil Dravida and his co-authors have developed the first comprehensive overview of its kind on Real-World Data (RWD) in the pharmaceutical industry. The authors examine the challenges and opportunities in applying real-world data along the pharmaceutical continuum, from clinical development to medical affairs, health economics and outcomes, and marketing. They address the difficulties identifying the suitable data sources, ensuring compliance with privacy, security and regulatory requirements, and the big job of translating data into Real-World Evidence (RWE) to generate meaningful insights that can improve decision making by stakeholders and measurable outcomes that can enhance people’s health and well-being. This book is a must-read for those in the pharmaceutical industry involved with RWD, which includes just about every role, as healthcare is now dominated by the need for high-quality data that can enable better decision-making. This book is especially critical for those designing and leading RWD Centers of Excellence in pharmaceutical companies and the service providers supporting the RWD ecosystem.

Real-World Evidence in the Pharmaceutical Landscape

Author: Sunil Dravida

Publisher:

Published: 2021-10-29

Total Pages: 288

ISBN-13: 9781662914089

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In Real-World Evidence in the Pharmaceutical Landscape, life science industry experts Sunil Dravida and his co-authors have developed the first comprehensive overview of its kind on Real-World Data (RWD) in the pharmaceutical industry. The authors examine the challenges and opportunities in applying real-world data along the pharmaceutical continuum, from clinical development to medical affairs, health economics and outcomes, and marketing. They address the difficulties identifying the suitable data sources, ensuring compliance with privacy, security and regulatory requirements, and the big job of translating data into Real-World Evidence (RWE) to generate meaningful insights that can improve decision making by stakeholders and measurable outcomes that can enhance people's health and well-being. This book is a must-read for those in the pharmaceutical industry involved with RWD, which includes just about every role, as healthcare is now dominated by the need for high-quality data that can enable better decision-making. This book is especially critical for those designing and leading RWD Centers of Excellence in pharmaceutical companies and the service providers supporting the RWD ecosystem.

Real-World Evidence in Drug Development and Evaluation

Author: Harry Yang

Publisher: CRC Press

Published: 2021-01-11

Total Pages: 191

ISBN-13: 0429676824

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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

Examining the Impact of Real-World Evidence on Medical Product Development

Author: National Academies of Sciences, Engineering, and Medicine

Publisher: National Academies Press

Published: 2019-04-05

Total Pages: 231

ISBN-13: 030948832X

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Randomized controlled trials (RCTs) have traditionally served as the gold standard for generating evidence about medical interventions. However, RCTs have inherent limitations and may not reflect the use of medical products in the real world. Additionally, RCTs are expensive, time consuming, and cannot answer all questions about a product or intervention. Evidence generated from real-world use, such as real-world evidence (RWE) may provide valuable information, alongside RCTs, to inform medical product decision making. To explore the potential for using RWE in medical product decision making, the National Academies of Sciences, Engineering, and Medicine planned a three-part workshop series. The series was designed to examine the current system of evidence generation and its limitations, to identify when and why RWE may be an appropriate type of evidence on which to base decisions, to learn from successful initiatives that have incorporated RWE, and to describe barriers that prevent RWE from being used to its full potential. This publication summarizes the discussions from the entire workshop series.

Neuroscience Trials of the Future

Author: National Academies of Sciences, Engineering, and Medicine

Publisher: National Academies Press

Published: 2016-11-07

Total Pages: 111

ISBN-13: 0309442583

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On March 3-4, 2016, the National Academies of Sciences, Engineering, and Medicine's Forum on Neuroscience and Nervous System Disorders held a workshop in Washington, DC, bringing together key stakeholders to discuss opportunities for improving the integrity, efficiency, and validity of clinical trials for nervous system disorders. Participants in the workshop represented a range of diverse perspectives, including individuals not normally associated with traditional clinical trials. The purpose of this workshop was to generate discussion about not only what is feasible now, but what may be possible with the implementation of cutting-edge technologies in the future.

Research and Development in the Pharmaceutical Industry (A CBO Study)

Author: Congressional Budget Office

Publisher: Lulu.com

Published: 2013-06-09

Total Pages: 65

ISBN-13: 1304121445

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Perceptions that the pace of new-drug development has slowed and that the pharmaceutical industry is highly profitable have sparked concerns that significant problems loom for future drug development. This Congressional Budget Office (CBO) study-prepared at the request of the Senate Majority Leader-reviews basic facts about the drug industry's recent spending on research and development (R&D) and its output of new drugs. The study also examines issues relating to the costs of R&D, the federal government's role in pharmaceutical research, the performance of the pharmaceutical industry in developing innovative drugs, and the role of expected profits in private firms' decisions about investing in drug R&D. In keeping with CBO's mandate to provide objective, impartial analysis, the study makes no recommendations. David H. Austin prepared this report under the supervision of Joseph Kile and David Moore. Colin Baker provided valuable consultation...

OECD Health Policy Studies Health Data Governance Privacy, Monitoring and Research

Author: OECD

Publisher: OECD Publishing

Published: 2015-10-05

Total Pages: 202

ISBN-13: 9264244565

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This report identifies eight key data governance mechanisms to maximise benefits to patients and to societies from the collection, linkage and analysis of health data, and to minimise risks to both patient privacy and the security of health data.

Improving and Accelerating Therapeutic Development for Nervous System Disorders

Author: Institute of Medicine

Publisher: National Academies Press

Published: 2014-02-06

Total Pages: 107

ISBN-13: 0309292492

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Improving and Accelerating Therapeutic Development for Nervous System Disorders is the summary of a workshop convened by the IOM Forum on Neuroscience and Nervous System Disorders to examine opportunities to accelerate early phases of drug development for nervous system drug discovery. Workshop participants discussed challenges in neuroscience research for enabling faster entry of potential treatments into first-in-human trials, explored how new and emerging tools and technologies may improve the efficiency of research, and considered mechanisms to facilitate a more effective and efficient development pipeline. There are several challenges to the current drug development pipeline for nervous system disorders. The fundamental etiology and pathophysiology of many nervous system disorders are unknown and the brain is inaccessible to study, making it difficult to develop accurate models. Patient heterogeneity is high, disease pathology can occur years to decades before becoming clinically apparent, and diagnostic and treatment biomarkers are lacking. In addition, the lack of validated targets, limitations related to the predictive validity of animal models - the extent to which the model predicts clinical efficacy - and regulatory barriers can also impede translation and drug development for nervous system disorders. Improving and Accelerating Therapeutic Development for Nervous System Disorders identifies avenues for moving directly from cellular models to human trials, minimizing the need for animal models to test efficacy, and discusses the potential benefits and risks of such an approach. This report is a timely discussion of opportunities to improve early drug development with a focus toward preclinical trials.

Evidence-Based Medicine and the Changing Nature of Health Care

Author: Institute of Medicine

Publisher: National Academies Press

Published: 2008-09-06

Total Pages: 202

ISBN-13: 0309113695

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Drawing on the work of the Roundtable on Evidence-Based Medicine, the 2007 IOM Annual Meeting assessed some of the rapidly occurring changes in health care related to new diagnostic and treatment tools, emerging genetic insights, the developments in information technology, and healthcare costs, and discussed the need for a stronger focus on evidence to ensure that the promise of scientific discovery and technological innovation is efficiently captured to provide the right care for the right patient at the right time. As new discoveries continue to expand the universe of medical interventions, treatments, and methods of care, the need for a more systematic approach to evidence development and application becomes increasingly critical. Without better information about the effectiveness of different treatment options, the resulting uncertainty can lead to the delivery of services that may be unnecessary, unproven, or even harmful. Improving the evidence-base for medicine holds great potential to increase the quality and efficiency of medical care. The Annual Meeting, held on October 8, 2007, brought together many of the nation's leading authorities on various aspects of the issues - both challenges and opportunities - to present their perspectives and engage in discussion with the IOM membership.

Virtual Clinical Trials

Author: National Academies of Sciences, Engineering, and Medicine

Publisher: National Academies Press

Published: 2019-11-16

Total Pages: 127

ISBN-13: 0309494885

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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.