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Author: Caroline Trouet Publisher: Intersentia nv ISBN: 9050954200 Category : Belgium Languages : en Pages : 288
Book Description
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.
Author: Caroline Trouet Publisher: Intersentia nv ISBN: 9050954200 Category : Belgium Languages : en Pages : 288
Book Description
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.
Author: Caroline Trouet Publisher: Intersentia Uitgevers N V ISBN: 9789050956871 Category : Law Languages : en Pages : 289
Book Description
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.
Author: Jane Reichel Publisher: Springer Nature ISBN: 3030493881 Category : Biobanks Languages : en Pages : 432
Book Description
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. .
Author: Maurice J. Staquet Publisher: Oxford University Press, USA ISBN: 9780192627858 Category : Health & Fitness Languages : en Pages : 360
Book Description
Researchers in all clinical fields are becoming increasingly aware of the importance of quality of life measurements in judging the efficacy of a given treatment, and it is becoming more common for psychological criteria to play an important role in the evaluation of therapies. In the past ten years a number of methods have been developed for carrying out such assessments. Quality of life research does however use special statistical methods which might well be unfamiliar to the clinician. Quality of life assessment in clinical trials: methods and practice explores these methods in a non-mathematical manner, comparing and contrasting the tools available to the clinician, and highlighting any potential pitfalls. It describes the methods used to collect and analyse quality of life data. The book will have widespread appeal to clinical trialists and researchers from a wide range of specialties.
Author: National Research Council Publisher: National Academies Press ISBN: 030918651X Category : Medical Languages : en Pages : 163
Book Description
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.
Author: OECD Publisher: OECD Publishing ISBN: 9264805907 Category : Languages : en Pages : 447
Book Description
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.
Author: Elke Gasthuys Publisher: Elsevier ISBN: 0323904297 Category : Medical Languages : en Pages : 732
Book Description
Essentials of Translational Pediatric Drug Development: From Past Needs to Future Opportunities provides integrated and up-to-date insights relevant for both translational researchers and clinicians active in the field of pediatric drug development. The book covers all key aspects from different stakeholder perspectives, providing a literature overview and careful reflection on state-of-the-art approaches. It will be an ideal guide for researchers in the field who are designing and performing high quality, innovative pediatric-adapted drug development by helping them define needs/challenges and possible solutions that advance and harmonize pediatric drug development.Despite the broad consensus that children merit the same quality of drug treatment as any other age group, children remain frequently neglected during drug research and development. Even with the adoption of multiple legislations addressing this problem, the lack of efficacy and safety data of marketed as well as newly developed drugs still remain in the pediatric population. Covers both theoretical and practical aspects of translational pediatric drug development Approaches the topic from different stakeholder perspectives (academics, industry, regulators, clinicians and patient/parent advocacy groups) Offers best practices and future perspectives for the improvement of translational pediatric drug development
Author: William Kevin Kelly, DO Publisher: Springer Publishing Company ISBN: 0826168736 Category : Medical Languages : en Pages : 568
Book Description
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
Author: Caroline Trouet
Author: Caroline Trouet
Author: Caroline Trouet
Author: Jane Reichel
Author: Jean-Paul Mira
Author: Maurice J. Staquet
Author: National Research Council
Author: OECD
Author: Elke Gasthuys
Author: 
Author: William Kevin Kelly, DO