Access to Non-Summary Clinical Trial Data for Research Purposes Under EU Law

Access to Non-Summary Clinical Trial Data for Research Purposes Under EU Law
Author: Daria Kim
Publisher: Springer Nature
Total Pages: 310
Release: 2021-10-19
Genre: Law
ISBN: 3030867781

This book draws a unique perspective on the regulation of access to clinical trial data as a case on research and knowledge externalities. Notwithstanding numerous potential benefits for medical research and public health, many jurisdictions have struggled to ensure access to clinical trial data, even at the level of the trial results. Pro-access policy initiatives have been strongly opposed by research-based drug companies arguing that mandatory data disclosure impedes their innovation incentives. Conventionally, access to test data has been approached from the perspective of transparency and research ethics. The book offers a complementary view and considers access to individual patient-level trial data for exploratory analysis as a matter of research and innovation policy. Such approach appears to be especially relevant in the data-driven economy where digital data constitutes a valuable economic resource. The study seeks to define how the rules of access to clinical trial data should be designed to reconcile the policy objectives of leveraging the research potential of data through secondary analysis, on the one hand, and protecting economic incentives of research-based drug companies, on the other hand. Overall, it is argued that the mainstream innovation-based justification for exclusive control over the outcomes of research and development can hardly rationalise trial sponsors’ control over primary data from trials. Instead, access to such data and its robust analysis should be prioritised.

A Practical Guide to Managing Clinical Trials

A Practical Guide to Managing Clinical Trials
Author: JoAnn Pfeiffer
Publisher: CRC Press
Total Pages: 292
Release: 2017-05-18
Genre: Mathematics
ISBN: 1315299771

A Practical Guide to Managing Clinical Trials is a basic, comprehensive guide to conducting clinical trials. Designed for individuals working in research site operations, this user-friendly reference guides the reader through each step of the clinical trial process from site selection, to site set-up, subject recruitment, study visits, and to study close-out. Topics include staff roles/responsibilities/training, budget and contract review and management, subject study visits, data and document management, event reporting, research ethics, audits and inspections, consent processes, IRB, FDA regulations, and good clinical practices. Each chapter concludes with a review of key points and knowledge application. Unique to this book is "A View from India," a chapter-by-chapter comparison of clinical trial practices in India versus the U.S. Throughout the book and in Chapter 10, readers will glimpse some of the challenges and opportunities in the emerging and growing market of Indian clinical trials.

Clinical Evaluation and Investigation of Medical Devices under the new EU-Regulation

Clinical Evaluation and Investigation of Medical Devices under the new EU-Regulation
Author: Wolfgang Ecker
Publisher: BoD – Books on Demand
Total Pages: 282
Release: 2020-06-04
Genre: Medical
ISBN: 3751937668

The concept of clinical evaluation and the framework for clinical investigations have been significantly enforced within the new EU-Medical Device Regulation (MDR). This book provides in-depth and practice-oriented guidance on the systematic identification and generation of clinical data through clinical investigations and other relevant sources. It addresses the needs of all stakeholders, be it manufacturers, notified bodies or competent authorities, when they have to plan, perform or assess clinical evaluations and investigations for medical devices on the way to conformity assessment and CE marking. It is a valuable tool of qualification for clinicians and related experts when preparing for a role of a clinical evaluator in the field, either when serving any of the stakeholders or when trying to make their own involvement stand out in start-ups. spin-offs or other development projects or in counselling services.

Improving Healthcare Quality in Europe Characteristics, Effectiveness and Implementation of Different Strategies

Improving Healthcare Quality in Europe Characteristics, Effectiveness and Implementation of Different Strategies
Author: OECD
Publisher: OECD Publishing
Total Pages: 447
Release: 2019-10-17
Genre:
ISBN: 9264805907

This volume, developed by the Observatory together with OECD, provides an overall conceptual framework for understanding and applying strategies aimed at improving quality of care. Crucially, it summarizes available evidence on different quality strategies and provides recommendations for their implementation. This book is intended to help policy-makers to understand concepts of quality and to support them to evaluate single strategies and combinations of strategies.

Fundamentals of Clinical Data Science

Fundamentals of Clinical Data Science
Author: Pieter Kubben
Publisher: Springer
Total Pages: 219
Release: 2018-12-21
Genre: Medical
ISBN: 3319997130

This open access book comprehensively covers the fundamentals of clinical data science, focusing on data collection, modelling and clinical applications. Topics covered in the first section on data collection include: data sources, data at scale (big data), data stewardship (FAIR data) and related privacy concerns. Aspects of predictive modelling using techniques such as classification, regression or clustering, and prediction model validation will be covered in the second section. The third section covers aspects of (mobile) clinical decision support systems, operational excellence and value-based healthcare. Fundamentals of Clinical Data Science is an essential resource for healthcare professionals and IT consultants intending to develop and refine their skills in personalized medicine, using solutions based on large datasets from electronic health records or telemonitoring programmes. The book’s promise is “no math, no code”and will explain the topics in a style that is optimized for a healthcare audience.

European Union Health Law

European Union Health Law
Author: Tamara K. Hervey
Publisher: Cambridge University Press
Total Pages: 749
Release: 2015-11-12
Genre: Law
ISBN: 1107010497

The first holistic and thematic study of EU health law, and its implications, through its own internal logics.

Rare Cancer Agenda 2030

Rare Cancer Agenda 2030
Author: Rare Cancers Europe
Publisher: Youcanprint
Total Pages: 131
Release: 2020-02-24
Genre: Law
ISBN: 8831642715

RARE CANCER AGENDA 2030 Ten Recommendations from the EU Joint Action on Rare Cancers 1. Rare cancers are the rare diseases of oncology 2. Rare cancers should be monitored 3. Health systems should exploit networking 4. Medical education should exploit and serve healthcare networking 5. Research should be fostered by networking and should take into account an expected higher degree of uncertainty 6. Patient-physician shared clinical decision-making should be especially valued 7. Appropriate state-of-the-art instruments should be developed in rare cancer 8. Regulation on rare cancers should tolerate a higher degree of uncertainty 9. Policy strategies on rare cancers and sustainability of interventions should be based on networking 10. Rare cancer patients should be engaged

Principles of Good Clinical Practice

Principles of Good Clinical Practice
Author: Michael J. McGraw
Publisher: Pharmaceutical Press
Total Pages: 273
Release: 2010
Genre: Business & Economics
ISBN: 0853697906

Part of "RPS Pharmacy Business Administration Series", this book offers good clinical practice guidelines. It includes standards on how clinical trials should be conducted, provide assurance of safety and efficacy of various drugs and protect human rights.

The Cambridge Handbook of Health Research Regulation

The Cambridge Handbook of Health Research Regulation
Author: Graeme Laurie
Publisher:
Total Pages: 444
Release: 2021-06-09
Genre: Law
ISBN: 1108576095

The definitive reference guide to designing scientifically sound and ethically robust medical research, considering legal, ethical and practical issues.