Guide to Paediatric Clinical Research
Guide to Paediatric Clinical Research

Author: Klaus Rose

Publisher: Karger Medical and Scientific Publishers

Published: 2007

Total Pages: 164

ISBN-13: 3805582013

DOWNLOAD EBOOK

As off-label use of medicines in children is no longer acceptable today, paediatric drug development is currently in transition from an almost exclusive academic specialty towards an integrated part of the global process that drives the development of new pharmaceuticals. US and EU governments have made it mandatory for the pharmaceutical industry to investigate medicines in children, thus exposing a multitude of different institutions to paediatric research. Written by exponents of the academia as well as the pharmaceutical industry, regulators and patient advocacy groups, this book explains the background of the US and EU paediatric legislations, gives an analysis of their probable short-, mid- and long-term impact, addresses key operational challenges in paediatric research, and develops a tentative vision where paediatric drug development needs to go. Helping to understand the role of the different stakeholders, the spectrum of readers to profit from this book ranges from paediatricians, general medical personnel and pharmacologists to those involved in regulatory affairs and clinical trials, pharmaceutical company management, patient advocacy groups, ethical committees, politicians and interested lay persons.

Guide to Paediatric Drug Development and Clinical Research
Guide to Paediatric Drug Development and Clinical Research

Author: K. Rose

Publisher: Karger Medical and Scientific Publishers

Published: 2010-05-21

Total Pages: 240

ISBN-13: 3805593635

DOWNLOAD EBOOK

Children in the developed world have never enjoyed better medical care: mortality has decreased and many fatal diseases of the past can today be prevented or even cured. However, the current practice of pharmacotherapy in children does not reflect existing scientific knowledge and has come under scrutiny by paediatricians, pharmacists and regulatory authorities. In order to advance the development of medicines tailored to paediatric needs, US and EU legislators have taken action, and the WHO has initiated a global paediatric campaign. This book gives an overview over the worldwide activities that increasingly include children in the development of new medicines. Triggered by both a better understanding of how the child’s body develops as well as recent legislation in the USA and in Europe, this comprises dosing, ethics, age-appropriate pharmaceutical forms and clinical trials, to name just a few aspects. A wide spectrum of readers will profit from this book, including paediatricians, pharmacists, general practitioners and health care professionals involved in child care and paediatric research, clinical trial personnel, patient advocacy groups, ethics committees, politicians, parents and interested lay persons.

Ethical Conduct of Clinical Research Involving Children
Ethical Conduct of Clinical Research Involving Children

Author: Institute of Medicine

Publisher: National Academies Press

Published: 2004-07-09

Total Pages: 445

ISBN-13: 0309133386

DOWNLOAD EBOOK

In recent decades, advances in biomedical research have helped save or lengthen the lives of children around the world. With improved therapies, child and adolescent mortality rates have decreased significantly in the last half century. Despite these advances, pediatricians and others argue that children have not shared equally with adults in biomedical advances. Even though we want children to benefit from the dramatic and accelerating rate of progress in medical care that has been fueled by scientific research, we do not want to place children at risk of being harmed by participating in clinical studies. Ethical Conduct of Clinical Research Involving Children considers the necessities and challenges of this type of research and reviews the ethical and legal standards for conducting it. It also considers problems with the interpretation and application of these standards and conduct, concluding that while children should not be excluded from potentially beneficial clinical studies, some research that is ethically permissible for adults is not acceptable for children, who usually do not have the legal capacity or maturity to make informed decisions about research participation. The book looks at the need for appropriate pediatric expertise at all stages of the design, review, and conduct of a research project to effectively implement policies to protect children. It argues persuasively that a robust system for protecting human research participants in general is a necessary foundation for protecting child research participants in particular.

Clinical Research in Paediatric Psychopharmacology
Clinical Research in Paediatric Psychopharmacology

Author: Philippe Auby

Publisher: Elsevier

Published: 2015-01-31

Total Pages: 0

ISBN-13: 9781908818607

DOWNLOAD EBOOK

Clinical research in pediatric psychopharmacology covers ethical, regulatory, clinical, scientific, intercultural and practical aspects of clinical research in child and adolescent psychopharmacology. Clinical Research in Paediatric Psychopharmacology: A Practical Guide is written and organized with the aim of being a practical guide, providing both an overview of clinical research in pediatric psychopharmacology and practical points to consider when developing clinical research in this field. Covers both theoretical and practical aspects Includes the regulatory framework and the patient perspective Priovides real insight rather than tips

Guide to Paediatric Drug Development and Clinical Research
Guide to Paediatric Drug Development and Clinical Research

Author: Klaus Rose

Publisher: Karger Medical and Scientific Publishers

Published: 2010-01-01

Total Pages: 240

ISBN-13: 3805593627

DOWNLOAD EBOOK

Children in the developed world have never enjoyed better medical care: mortality has decreased and many fatal diseases of the past can today be prevented or even cured. However, the current practice of pharmacotherapy in children does not reflect existing scientific knowledge and has come under scrutiny by paediatricians, pharmacists and regulatory authorities. In order to advance the development of medicines tailored to paediatric needs, US and EU legislators have taken action, and the WHO has initiated a global paediatric campaign. This book gives an overview over the worldwide activities that increasingly include children in the development of new medicines. Triggered by both a better understanding of how the child's body develops as well as recent legislation in the USA and in Europe, this comprises dosing, ethics, age-appropriate pharmaceutical forms and clinical trials, to name just a few aspects.A wide spectrum of readers will profit from this book, including paediatricians, pharmacists, general practitioners and health care professionals involved in child care and paediatric research, clinical trial personnel, patient advocacy groups, ethics committees, politicians, parents and interested lay persons.

Pediatrician's Guide to Discussing Research with Patients
Pediatrician's Guide to Discussing Research with Patients

Author: Christina A. Di Bartolo

Publisher: Springer

Published: 2017-01-11

Total Pages: 260

ISBN-13: 331949547X

DOWNLOAD EBOOK

With the proliferation of research studies posted online, media outlets scrambling to pick up stories, and individuals posting unverified information via social media, the landscape for parents trying to understand the latest science as it pertains to their children has never been more challenging to navigate. This book is intended to assist pediatricians when discussing research findings with parents. It provides an overview of research practices and terminology, clarifies misconceptions about studies and findings, and explains the limitations of research when applied to medical decision making. Through this framework, physicians can explain their reasoning behind specific clinical recommendations. In addition to examining the broad concepts comprising research literacy, this book reviews the current findings in topics that pediatricians report discussing most often with parents, such as vaccines, diet, medications, and sleep. Pediatrician’s Guide to Discussing Research with Patients is a unique resource for pediatricians in encouraging the development of research literacy in their patients.

Clinical Research in Paediatric Psychopharmacology
Clinical Research in Paediatric Psychopharmacology

Author: Philippe Auby

Publisher: Woodhead Publishing

Published: 2019-09-15

Total Pages: 218

ISBN-13: 0081006179

DOWNLOAD EBOOK

Clinical Research in Paediatric Psychopharmacology: An Overview of the Ethical, Scientific and Regulatory Aspects provides a practical guide and overview of the ethical, scientific and regulatory aspects of clinical research in pediatric psychopharmacology, also discussing practical points to consider when developing clinical research in this field. The book is ideal for professionals involved in clinical research in pediatric psychopharmacology, i.e., including, but not limited to pediatricians, health care professionals, researchers, investigators, pharmaceutical company personals and potentially ethics committee members. Topics discussed include the role of patient organization and advocacy groups in research, the role of families and patients: ‘should I involve my kid in clinical research, and historical, ethical, regulatory, clinical, scientific, intercultural and practical aspects of clinical research in child and adolescent psychopharmacology. Covers both theoretical and practical aspects of clinical research in paediatric psychopharmacology Approaches the topic from different angles from the regulatory framework to the patient perspective Discusses ethical and safety considerations for research in paediatric psychopharmacology Offers future perspective for paediatric development

Clinical Guide to Paediatrics
Clinical Guide to Paediatrics

Author: Rachel Varughese

Publisher: John Wiley & Sons

Published: 2022-06-15

Total Pages: 626

ISBN-13: 1119539099

DOWNLOAD EBOOK

Clinical Guide to Paediatrics enables rapid reference to the common paediatric conditions, symptoms, and practical concerns seen in day-to-day practice. Focused on making differential diagnoses in acute settings, this comprehensive resource offers step-by-step guidance on clinical decision-making, investigations, and interventions. Junior doctors and medical students are provided with a clear and up-to-date evidence base supported by numerous diagnostic algorithms, diagrams, tables and bullet points throughout. Organised into systems-based sections, the guide covers paediatric history taking, examination techniques, pharmacology, safeguarding, and a range of different diagnoses for presenting complaints in cardiology, infection and immunology, neurology, gastroenterology, accidents, poisoning, and more. Succinct chapters are logically structured to allow easy access to important concepts, key clinical details, and plans of investigation. Designed to complement the doctor-patient interaction in clinical practice, this valuable guide: Covers the most common presenting complaints encountered in acute paediatrics Provides evidence-based information on symptoms, disorders, and issues faced in paediatric medicine Addresses topics from the perspective of presenting complaints to provide a unique, highly practical approach to the subject Includes access to a companion website containing images and clinical photos, audio podcasts, clinical case studies, and self-assessment exercises Clinical Guide to Paediatrics is essential reading for junior doctors, medical students, nurses and specialist trainees working on paediatric wards or emergency departments.

Pediatric Evidence
Pediatric Evidence

Author: Lindsay Carter

Publisher: Lippincott Williams & Wilkins

Published: 2016-01-11

Total Pages: 444

ISBN-13: 1496345185

DOWNLOAD EBOOK

Increase your knowledge of the clinical trials and evidence that lay the groundwork for current practice with Pediatric Evidence: The Practice-Changing Studies. Brief, easy-to-read, and accessible, this time-saving reference allows you to quickly familiarize yourself with the 100 most practice-changing clinical trials in pediatrics. This unique title is ideal for medical students, residents, and seasoned practitioners alike, providing insight and understanding into today’s practice of pediatrics. Save time and effort with convenient, succinct synopses of each study, including editorial commentary on the impact of the trial and the context for incorporating it into practice. Access an important mix of historical and contemporary studies, with an emphasis on material most relevant to today’s practice. Explore landmark clinical trials in all areas of pediatrics, including the subspecialties of allergy/immunology, cardiology, critical care, emergency medicine, endocrinology, gastroenterology, genetics, hematology/oncology, infectious diseases, neonatology, neurology, primary care, psychiatry, renal, and rheumatology.