Download or read book Clinical Trials in Belgium written by Caroline Trouet and published by Intersentia nv. This book was released on 2004 with total page 288 pages. Available in PDF, EPUB and Kindle. Book excerpt: In line with its strong position in clinical research, Belgium is one of the first European Member States where the implementing regulation of the Clinical Trials Directive is fully operational. The specific conditions provided for in the new law concerning experiments on the human person (May 7, 2004) reinforce Belgium as a very attractive host for clinical trials, ensuring a lasting environment for innovative research. pharma.be, the Belgian Pharmaceutical Industry Association, wants to contribute its part to research in Belgium by clarifying the practical implications of the new regulations. At its request, dr. iur. Caroline Trouet wrote an Operational Guidance, which analyses the new Belgian law from the perspective of the sponsor of a clinical trial, but addresses the roles and tasks of all parties involved in clinical trials. In order to assist everyone involved in clinical trials in the practical implementation of the new law, the Guidance provides for a short and comprehensive overview and insight into the process flows of the submission to and evaluation by the competent authority and the ethics committee of a clinical trials application. In addition, standard templates for the most important documents are added. The text is useful, both for study sponsors and for all other actors in the field of medical research and development such as members of ethics committees, physicians, pharmacists, administrators etc.; by those who have had access to the manuscript, it is already qualified as the standard textbook on the new EU legal framework and its transposition into Belgian law.
Download or read book GDPR and Biobanking written by Jane Reichel and published by Springer Nature. This book was released on 2021 with total page 432 pages. Available in PDF, EPUB and Kindle. Book excerpt: Part I Setting the scene -- Introduction: Individual rights, the public interest and biobank research 4000 (8) -- Genetic data and privacy protection -- Part II GDPR and European responses -- Biobank governance and the impact of the GDPR on the regulation of biobank research -- Controller' and processor's responsibilities in biobank research under GDPR -- Individual rights in biobank research under GDPR -- Safeguards and derogations relating to processing for archiving purposes in the scientific purposes: Article 89 analysis for biobank research -- A Pan-European analysis of Article 89 implementation and national biobank research regulations -- EEA, Switzerland analysis of GDPR requirements and national biobank research regulations -- Part III National insights in biobank regulatory frameworks -- Selected 10-15 countries for reports: Germany -- Greece -- France -- Finland -- Sweden -- United Kingdom -- Part IV Conclusions -- Reflections on individual rights, the public interest and biobank research, ramifications and ways forward. .
Download or read book The Prevention and Treatment of Missing Data in Clinical Trials written by National Research Council and published by National Academies Press. This book was released on 2010-12-21 with total page 163 pages. Available in PDF, EPUB and Kindle. Book excerpt: Randomized clinical trials are the primary tool for evaluating new medical interventions. Randomization provides for a fair comparison between treatment and control groups, balancing out, on average, distributions of known and unknown factors among the participants. Unfortunately, these studies often lack a substantial percentage of data. This missing data reduces the benefit provided by the randomization and introduces potential biases in the comparison of the treatment groups. Missing data can arise for a variety of reasons, including the inability or unwillingness of participants to meet appointments for evaluation. And in some studies, some or all of data collection ceases when participants discontinue study treatment. Existing guidelines for the design and conduct of clinical trials, and the analysis of the resulting data, provide only limited advice on how to handle missing data. Thus, approaches to the analysis of data with an appreciable amount of missing values tend to be ad hoc and variable. The Prevention and Treatment of Missing Data in Clinical Trials concludes that a more principled approach to design and analysis in the presence of missing data is both needed and possible. Such an approach needs to focus on two critical elements: (1) careful design and conduct to limit the amount and impact of missing data and (2) analysis that makes full use of information on all randomized participants and is based on careful attention to the assumptions about the nature of the missing data underlying estimates of treatment effects. In addition to the highest priority recommendations, the book offers more detailed recommendations on the conduct of clinical trials and techniques for analysis of trial data.
Download or read book Clinical Trials in Belgium written by Caroline Trouet and published by Intersentia Uitgevers N V. This book was released on 2007 with total page 289 pages. Available in PDF, EPUB and Kindle. Book excerpt: In line with its strong position in clinical research, Belgium was one of the first European Member States where the implementing regulation of the Clinical Trials Directive is fully operational. The specific conditions provided for in the legislation concerning experiments on the human person reinforce Belgium as a very attractive host for clinical trials, ensuring a lasting environment for innovative research. Pharma.be, the Belgian Pharmaceutical Industry Association, wants to contribute its part to research in Belgium by clarifying the practical implications of the new regulations. This new edition of the Operational Guidance does not only analyse the Belgian law from the perspective of the sponsor of a clinical trial, but also addresses the roles and tasks of all parties involved in clinical trials. In order to assist everyone involved in clinical trials, the Guidance provides for a short and comprehensive overview and insight into the process flows of the submission to and evaluation by the competent authority and the ethics committee of a clinical trials application. In addition, standard templates for the most important documents are added on a cd rom. This book is extremely useful, both for study sponsors and for all other actors in the field of medical research and development such as members of ethics committees, physicians, pharmacists, administrators, etc. The first edition of Clinical Trials in Belgium was very soon qualified as the standard textbook on the new EU legal framework and its transposition into Belgian law.
Download or read book Improving Healthcare Quality in Europe Characteristics Effectiveness and Implementation of Different Strategies written by OECD and published by OECD Publishing. This book was released on 2019-10-17 with total page 447 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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.
Download or read book Oncology Clinical Trials written by William Kevin Kelly, DO and published by Springer Publishing Company. This book was released on 2018-03-28 with total page 568 pages. Available in PDF, EPUB and Kindle. Book excerpt: The second edition of Oncology Clinical Trials has been thoroughly revised and updated and now contains the latest designs and methods of conducting and analyzing cancer clinical trials in the era of precision medicine with biologic agents—including trials investigating the safety and efficacy of targeted therapies, immunotherapies, and combination therapies as well as novel radiation therapy modalities. Now divided into six sections this revamped book provides the necessary background and expert guidance from the principles governing oncology clinical trials to the innovative statistical design methods permeating the field; from conducting trials in a safe and effective manner, analyzing and interpreting the data, to a forward-looking assessment and discussion of regulatory issues impacting domestic, international, and global clinical trials. Considered by many as the gold standard reference on oncology clinical trials in the field, the second edition continues to provide examples of real-life flaws and real-world examples for how to successfully design, conduct and analyze quality clinical trials and interpret them. With chapters written by oncologists, researchers, biostatisticians, clinical research administrators, and industry and FDA representatives, this volume provides a comprehensive guide in the design, conduct, monitoring, analysis, and reporting of clinical trials in oncology. NEW TO THIS EDITION: Outlines how to design clinical trials with and without biomarker testing—including genomics-based “basket” trials, and adaptive trials for all phases during treatment and quality-of-life trials Includes new chapters on immunotherapy trials, radiation therapy trials, multi-arm trials, meta-analysis and adaptive design, use of genomics, dose modifications and use of ancillary treatments in investigational studies, establishing surrogate endpoints, practical issues with correlative studies, cost-effectiveness analysis, and more Comprehensively covers all regulatory aspects in the pursuit of global oncology trials Digital access to the ebook included
Download or read book Medical Law in Belgium written by Herman Nys and published by Kluwer Law International B.V.. This book was released on 2023-02-20 with total page 420 pages. Available in PDF, EPUB and Kindle. Book excerpt: Derived from the renowned multi-volume International Encyclopaedia of Laws, this convenient volume provides comprehensive analysis of the law affecting the physician-patient relationship in Belgium. Cutting across the traditional compartments with which lawyers are familiar, medical law is concerned with issues arising from this relationship, and not with the many wider juridical relations involved in the broader field of health care law. After a general introduction, the book systematically describes law related to the medical profession, proceeding from training, licensing, and other aspects of access to the profession, through disciplinary and professional liability and medical ethics considerations and quality assurance, to such aspects of the physician-patient relationship as rights and duties of physicians and patients, consent, privacy, and access to medical records. Also covered are specific issues such as organ transplants, human medical research, abortion, and euthanasia, as well as matters dealing with the physician in relation to other health care providers, health care insurance, and the health care system. Succinct and practical, this book will prove to be of great value to professional organizations of physicians, nurses, hospitals, and relevant government agencies. Lawyers representing parties with interests in Belgium will welcome this very useful guide, and academics and researchers will appreciate its comparative value as a contribution to the study of medical law in the international context.
Download or read book Assessment of Diagnostic Technology in Health Care written by Institute of Medicine and published by National Academies Press. This book was released on 1989-02-01 with total page 152 pages. Available in PDF, EPUB and Kindle. Book excerpt: Technology assessment can lead to the rapid application of essential diagnostic technologies and prevent the wide diffusion of marginally useful methods. In both of these ways, it can increase quality of care and decrease the cost of health care. This comprehensive monograph carefully explores methods of and barriers to diagnostic technology assessment and describes both the rationale and the guidelines for meaningful evaluation. While proposing a multi-institutional approach, it emphasizes some of the problems involved and defines a mechanism for improving the evaluation and use of medical technology and essential resources needed to enhance patient care.
Download or read book Guide to Tax Rulings in Belgium written by René Willems and published by IBFD. This book was released on 2012 with total page 403 pages. Available in PDF, EPUB and Kindle. Book excerpt: Belgium is a leading business centre, due to its geographical location at the heart of Europe, its multicultural population and its history. Multinational corporations (MNCs), both foreign and home grown, constitute the engine of Belgium's economy, making Belgium one of the most globalized countries in the world. With its large number of foreign investors, Belgium's tax legislators are aware of the importance of upfront legal certainty and, for this reason, the legal framework for a general formal rulings system was introduced as from 2003. 'Guide to Tax Rulings in Belgium' provides a unique insight into the Belgian tax structure and its world-class tax rulings system. The book begins with a high-level overview of the main tax issues that investors might face and a description of the Belgian tax rulings system. From a business perspective, the book sets out how tax rulings can support investors in establishing, operating or changing their business infrastructure in Belgium.
Download or read book Design and Analysis of Clinical Trials for Predictive Medicine written by Shigeyuki Matsui and published by CRC Press. This book was released on 2015-03-19 with total page 394 pages. Available in PDF, EPUB and Kindle. Book excerpt: Design and Analysis of Clinical Trials for Predictive Medicine provides statistical guidance on conducting clinical trials for predictive medicine. It covers statistical topics relevant to the main clinical research phases for developing molecular diagnostics and therapeutics-from identifying molecular biomarkers using DNA microarrays to confirming
Download or read book The Unitary Patent Package Unified Patent Court written by Luc Desaunettes-Barbero and published by Ledizioni. This book was released on 2023-06-09 with total page 412 pages. Available in PDF, EPUB and Kindle. Book excerpt: As of 1st of June 2023, after years of negotiations, setbacks and postponements, the Unitary Patent Package (UPP) enters into force: the European patent with unitary effect (EPUE) becomes a reality and the Unified Patent Court (UPC) starts its activities. Regrettably, the patent regime put in place is not a genuine EU system. Adopted through an enhanced cooperation procedure, it firstly does not include all EU Member States. Secondly, the conditions and the procedure for granting EPUE is in the hands of the European Patent Office, an international organization to which EU is not a party. Lastly, the substantive provisions and the litigation proceedings are defined by an international treaty (the UPC Agreement) to which EU is not a member, and by national laws for the remaining aspects. Such system carves patent law out of the EU legal and judicial orders and reduces the roles of the EU Parliament and Court of Justice. Challenges are numerous in terms of complexity, harmonization objectives, legality, business advantages and wider societal, economic and legal concerns, to name a few. With twenty-eight contributions from academics and practitioners, this book starts with putting the new system into historical, comparative and institutional contexts (Part I) before highlighting some issues under EU law and the perspective of EU integration (Part II). The institutional, jurisdictional and procedural questions raised by the UPC are then addressed (Part III), as well as the innovation and markets issues (Part IV). The last contributions discuss possible improvements and alternatives to the Unitary Patent Package (Part V).
Download or read book Perspectives in digital health and big data in medicine Current trends professional challenges and ethical legal and social implications written by João Valente Cordeiro and published by Frontiers Media SA. This book was released on 2023-10-25 with total page 291 pages. Available in PDF, EPUB and Kindle. Book excerpt:
Download or read book Novel PET Radiotracers with Potential Clinical Applications An Issue of PET Clinics written by Neil Vasdev and published by Elsevier Health Sciences. This book was released on 2017-06-08 with total page 121 pages. Available in PDF, EPUB and Kindle. Book excerpt: This issue of PET Clinics focuses on Radiotracers, and is edited by Drs. Neil Vasdev and Abass Alavi. Articles will include: PET/CT detection of HER2-positive metastases in patients with 89Zr-DFO-trastuzumab; uPAR-PET with 68Ga-NOTA-AE105: first clinical experience with a novel PET ligand; 64Cu-FBP8: A fibrin-targeted probe for imaging of thrombus; Imaging of synaptic density in the brain via synaptic vesicle glycoprotein 2A (SV2A) with a novel biomarker [11C]UCB-J; Neuroimaging of stress sensitive and neuroinflammatory targets in mood disorders; Impact of MR-based PET motion correction on the quantification of PET kinetic parameters in simultaneous cardiac PET-MR; Multimodal studies of the contributions of amyloid and tau burden to neurodegeneration in AD, FTD and Non-AD tauopathies; Imaging of prostate-specific membrane antigen (PSMA) using [18F]DCFPyL; Ga-68 GRPR antagonist imaging; and more!
Download or read book Analysis of Clinical Trials Using SAS written by Alex Dmitrienko and published by SAS Institute. This book was released on 2017-07-17 with total page 455 pages. Available in PDF, EPUB and Kindle. Book excerpt: Analysis of Clinical Trials Using SAS®: A Practical Guide, Second Edition bridges the gap between modern statistical methodology and real-world clinical trial applications. Tutorial material and step-by-step instructions illustrated with examples from actual trials serve to define relevant statistical approaches, describe their clinical trial applications, and implement the approaches rapidly and efficiently using the power of SAS. Topics reflect the International Conference on Harmonization (ICH) guidelines for the pharmaceutical industry and address important statistical problems encountered in clinical trials. Commonly used methods are covered, including dose-escalation and dose-finding methods that are applied in Phase I and Phase II clinical trials, as well as important trial designs and analysis strategies that are employed in Phase II and Phase III clinical trials, such as multiplicity adjustment, data monitoring, and methods for handling incomplete data. This book also features recommendations from clinical trial experts and a discussion of relevant regulatory guidelines. This new edition includes more examples and case studies, new approaches for addressing statistical problems, and the following new technological updates: SAS procedures used in group sequential trials (PROC SEQDESIGN and PROC SEQTEST) SAS procedures used in repeated measures analysis (PROC GLIMMIX and PROC GEE) macros for implementing a broad range of randomization-based methods in clinical trials, performing complex multiplicity adjustments, and investigating the design and analysis of early phase trials (Phase I dose-escalation trials and Phase II dose-finding trials) Clinical statisticians, research scientists, and graduate students in biostatistics will greatly benefit from the decades of clinical research experience and the ready-to-use SAS macros compiled in this book.
Download or read book Cancer Research Supported Under BIOMED 1 written by S. S. Baig and published by IOS Press. This book was released on 1998 with total page 406 pages. Available in PDF, EPUB and Kindle. Book excerpt: The pace of discovery, within the EU, of scientific aspects of cancer research and of developments in the clinical field is so rapid that it is sometimes difficult to keep abreast. This brief overview attempts to highlight some of the advances in the field, as part of BIOMED programme funded research and specific results due to the co-operative spirit established by the scientific community. It is particularly worth noting the financial investment of 35 million ECU in the current programme, has d as a catalyst in attracting a large number of Member States funded research in pooling their collective knowledge base.
Download or read book Principles and Practice of Clinical Trials written by Steven Piantadosi and published by Springer Nature. This book was released on 2022-07-19 with total page 2573 pages. Available in PDF, EPUB and Kindle. Book excerpt: This is a comprehensive major reference work for our SpringerReference program covering clinical trials. Although the core of the Work will focus on the design, analysis, and interpretation of scientific data from clinical trials, a broad spectrum of clinical trial application areas will be covered in detail. This is an important time to develop such a Work, as drug safety and efficacy emphasizes the Clinical Trials process. Because of an immense and growing international disease burden, pharmaceutical and biotechnology companies continue to develop new drugs. Clinical trials have also become extremely globalized in the past 15 years, with over 225,000 international trials ongoing at this point in time. Principles in Practice of Clinical Trials is truly an interdisciplinary that will be divided into the following areas: 1) Clinical Trials Basic Perspectives 2) Regulation and Oversight 3) Basic Trial Designs 4) Advanced Trial Designs 5) Analysis 6) Trial Publication 7) Topics Related Specific Populations and Legal Aspects of Clinical Trials The Work is designed to be comprised of 175 chapters and approximately 2500 pages. The Work will be oriented like many of our SpringerReference Handbooks, presenting detailed and comprehensive expository chapters on broad subjects. The Editors are major figures in the field of clinical trials, and both have written textbooks on the topic. There will also be a slate of 7-8 renowned associate editors that will edit individual sections of the Reference.
Download or read book Chronic Hepatitis C Virus New Insights for the Healthcare Professional 2012 Edition written by and published by ScholarlyEditions. This book was released on 2012-12-10 with total page 99 pages. Available in PDF, EPUB and Kindle. Book excerpt: Chronic Hepatitis C Virus: New Insights for the Healthcare Professional / 2012 Edition is a ScholarlyBrief™ that delivers timely, authoritative, comprehensive, and specialized information about Chronic Hepatitis C Virus in a concise format. The editors have built Chronic Hepatitis C Virus: New Insights for the Healthcare Professional / 2012 Edition on the vast information databases of ScholarlyNews.™ You can expect the information about Chronic Hepatitis C Virus in this eBook to be deeper than what you can access anywhere else, as well as consistently reliable, authoritative, informed, and relevant. The content of Chronic Hepatitis C Virus: New Insights for the Healthcare Professional / 2012 Edition has been produced by the world’s leading scientists, engineers, analysts, research institutions, and companies. All of the content is from peer-reviewed sources, and all of it is written, assembled, and edited by the editors at ScholarlyEditions™ and available exclusively from us. You now have a source you can cite with authority, confidence, and credibility. More information is available at http://www.ScholarlyEditions.com/.
