Global Clinical Trials Playbook Book

Global Clinical Trials Playbook


  • Author : Menghis Bairu
  • Publisher : Academic Press
  • Release Date : 2012-04-20
  • Genre: Medical
  • Pages : 332
  • ISBN 10 : 9780124157873

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Global Clinical Trials Playbook Excerpt :

Pharmaceuticals companies, biotech companies, and CROs, regardless of size, all face the same challenge of managing costs and operational execution associated with bringing a valuable drugs and devices to market. Because of timeline pressures and cost as well as the growing interest in "neglected diseases" and diseases affecting the emerging nations, clinical trials are increasingly conducted in emerging markets and developing countries where infrastructure, leadership, skilled personnel and a governance are at a premium. Working with academics, regulatory professionals, safety officers, experts from the pharma industry and CROs, the editors have put together this up-to-date, step-by-step guide book to building and enhancing global clinical trial capacity in emerging markets and developing countries. This book covers the design, conduct, and tools to build and/or enhance human capacity to execute such trials, appealing to individuals in health ministries, pharmaceutical companies, world health organizations, academia, industry, and non-governmental organizations (NGOs) who are managing global clinical trials. Gives medical professionals the business tools needed to effectively execute clinical trials throughout the world Provides real world international examples which illustrate the practical translation of principles Includes forms, templates, and additional references for standardization in a number of global scenarios

Global Clinical Trials Playbook Book
Score: 5
From 1 Ratings

Global Clinical Trials Playbook


  • Author : Menghis Bairu
  • Publisher : Academic Press
  • Release Date : 2012-06-12
  • Genre: Medical
  • Pages : 320
  • ISBN 10 : 9780124158603

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Global Clinical Trials Playbook Excerpt :

Pharmaceuticals companies, biotech companies, and CROs, regardless of size, all face the same challenge of managing costs and operational execution associated with bringing a valuable drugs and devices to market. Because of timeline pressures and cost as well as the growing interest in "neglected diseases" and diseases affecting the emerging nations, clinical trials are increasingly conducted in emerging markets and developing countries where infrastructure, leadership, skilled personnel and a governance are at a premium. Working with academics, regulatory professionals, safety officers, experts from the pharma industry and CROs, the editors have put together this up-to-date, step-by-step guide book to building and enhancing global clinical trial capacity in emerging markets and developing countries. This book covers the design, conduct, and tools to build and/or enhance human capacity to execute such trials, appealing to individuals in health ministries, pharmaceutical companies, world health organizations, academia, industry, and non-governmental organizations (NGOs) who are managing global clinical trials. Gives medical professionals the business tools needed to effectively execute clinical trials throughout the world Provides real world international examples which illustrate the practical translation of principles Includes forms, templates, and additional references for standardization in a number of global scenarios

Global Clinical Trials Book

Global Clinical Trials


  • Author : Richard Chin
  • Publisher : Academic Press
  • Release Date : 2016-07-14
  • Genre: Medical
  • Pages : 522
  • ISBN 10 : 0128103558

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Global Clinical Trials Excerpt :

This book will explore the great opportunities and challenges which exist in conducting clinical trials in developing countries. By exploring the various regulations specific to the major players and providing insight into the logistical challenges including language barriers, this book provides a working tool for clinical researchers and administrators to navigate the intricacies of clinical trials in developing countries. Important topics such as ethical issues will be handled very carefully to highlight the significant differences of conducting this work in various jurisdictions. Overall, it will present a clear and comprehensive guide to the ins-and-outs of clinical trials in various countries to assist in design, development, and effectiveness of these trials. Contributors include high-profile, respected figures who have paved the way for clinical trials in developing countries Provides hands-on tools for regulatory and legal requirements and qualification, design, management, and reporting Case studies outline successes, failures, lessons learned and prospects for future collaboration Includes country-specific guidelines for the most utilized countries Foreword by David Feigel, former Head of CDRH at FDA

Global Clinical Trials for Alzheimer s Disease Book

Global Clinical Trials for Alzheimer s Disease


  • Author : Menghis Bairu
  • Publisher : Academic Press
  • Release Date : 2013-08-28
  • Genre: Medical
  • Pages : 432
  • ISBN 10 : 9780124115309

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Global Clinical Trials for Alzheimer s Disease Excerpt :

Global Clinical Trials for Alzheimer’s Disease is a handy one-stop reference for researchers and physicians planning and conducting global clinical trials in this area. This book addresses important considerations that may arise during the successful design and execution of these trials, including site selection, local regulatory issues, pharmacogenomics, ethical matters and much more. Given the saturation of traditional clinical trial markets and the worldwide progression of Alzheimer’s disease, there is a need to focus on clinical trials in emerging markets and developing countries. This book provides you with a practical approach to recognizing the opportunities and tackling the challenges that are present during the planning and execution of global clinical trials for Alzheimer’s disease. Written by leading experts with hands-on experience in designing and running global Alzheimer’s disease and other neurodegenerative diseases clinical trials A step-by-step guide that provides critical information on the design, conduct and standardization necessary to effectively execute clinical trials and accelerate drug development in this area Includes practical examples, ethical considerations, lessons learned and other valuable tools to aid the planning and implementation of Alzheimer’s disease global clinical trials in emerging markets and developing countries

Global Clinical Trials for Alzheimer s Disease Book

Global Clinical Trials for Alzheimer s Disease


  • Author : Menghis Bairu
  • Publisher : Academic Press
  • Release Date : 2013-09-18
  • Genre: Medical
  • Pages : 407
  • ISBN 10 : 0124114644

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Global Clinical Trials for Alzheimer s Disease Excerpt :

Global Clinical Trials for Alzheimer's Disease is a handy one-stop reference for researchers and physicians planning and conducting global clinical trials in this area. This book addresses important considerations that may arise during the successful design and execution of these trials, including site selection, local regulatory issues, pharmacogenomics, ethical matters and much more. Given the saturation of traditional clinical trial markets and the worldwide progression of Alzheimer's disease, there is a need to focus on clinical trials in emerging markets and developing countries. This book provides you with a practical approach to recognizing the opportunities and tackling the challenges that are present during the planning and execution of global clinical trials for Alzheimer's disease. Written by leading experts with hands-on experience in designing and running global Alzheimer's disease and other neurodegenerative diseases clinical trials A step-by-step guide that provides critical information on the design, conduct and standardization necessary to effectively execute clinical trials and accelerate drug development in this area Includes practical examples, ethical considerations, lessons learned and other valuable tools to aid the planning and implementation of Alzheimer's disease global clinical trials in emerging markets and developing countries

Global Clinical Trials for Alzheimer   s Disease Book

Global Clinical Trials for Alzheimer s Disease


  • Author : Yağız Üresin
  • Publisher : Elsevier Inc. Chapters
  • Release Date : 2013-08-28
  • Genre: Medical
  • Pages : 432
  • ISBN 10 : 9780128070529

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Global Clinical Trials for Alzheimer s Disease Excerpt :

Turkey straddles the continents of Europe and Asia, and this unique geographical location steers its economy. On the world economic scale, as an exceptional emerging economy, Turkey is the 16th largest economy in the world and the sixth largest economy as compared with the European Union countries, according to gross domestic product. The Turkish pharmaceutical sector is ranked 16th in terms of market value, and it is 36th in terms of the clinical research conducted and the volume of pharmaceutical exports. Investments by foreign companies have increased since 1984 and 19 foreign capital firms have entered the Turkish pharmaceuticals market since 1990. Today, there are approximately 300 entities operating in Turkey. Turkey has a long tradition of providing clinical trial legislation, regulation and guidelines; the country has taken major steps towards harmonizing its legislation with those of the European Union in the field of clinical research. Currently Turkish regulations are completely in line with EC Directives. Clinical trials performed in the field of Alzheimer’s disease in Turkey since 1997, including their rationale, design, summary, and outcomes, are discussed in this chapter.

Global Clinical Trials for Alzheimer   s Disease Book

Global Clinical Trials for Alzheimer s Disease


  • Author : Sidney A. Spector
  • Publisher : Elsevier Inc. Chapters
  • Release Date : 2013-08-28
  • Genre: Medical
  • Pages : 432
  • ISBN 10 : 9780128070567

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Global Clinical Trials for Alzheimer s Disease Excerpt :

Decades ago, pharmacogenetic research established that one’s genetic profile might predict efficacy and safety of medicines. Polymorphic expression of isoenzymes of the cytochrome P-450 enzyme system explains a significant amount of the variability of inter-individual responses to medicines. In Alzheimer’s disease, the highly variable clinical response to cholinesterase inhibitors metabolized by the liver is explained on this basis. More recently, translation of basic pharmacogenomic research through the drug development process has led to the approval of ”personalized“ medicines, for example, in the field of oncology, cardiology and psychiatry, based on an individual’s underlying genotypic variance of phenotypically expressed pathogenic targets and pathways. Translational pharmacogenomic research in Alzheimer’s disease has emerged as a viable alternative to the study of large populations with similar phenotypic expression of symptoms through stratification of sub-groups based on ApoE carrier status in clinical trials. When initiating a global research protocol, it is incumbent upon sponsors to actively engage stakeholders in developing and underdeveloped countries, including local government authorities, regulatory bodies, ethics review boards, community representatives and participants, to address all aspects of the clinical trial, especially informed consent, which may be more challenging in countries where local customs and practices dictate the need for innovative approaches. Implementation of pharmacogenomics in the clinical trial requires further attention to ethical detail related to what kind of informed consent is needed for use of stored DNA samples for future, unforeseen related or unrelated research, whether and to whom to disclose current and future study results, and ways by which the benefits of current and future discoveries are shared by stakeholders in developed and underdeveloped or developing countries.

Clinical Practice Guidelines We Can Trust Book

Clinical Practice Guidelines We Can Trust


  • Author : Institute of Medicine
  • Publisher : National Academies Press
  • Release Date : 2011-06-16
  • Genre: Medical
  • Pages : 290
  • ISBN 10 : 9780309216463

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Clinical Practice Guidelines We Can Trust Excerpt :

Advances in medical, biomedical and health services research have reduced the level of uncertainty in clinical practice. Clinical practice guidelines (CPGs) complement this progress by establishing standards of care backed by strong scientific evidence. CPGs are statements that include recommendations intended to optimize patient care. These statements are informed by a systematic review of evidence and an assessment of the benefits and costs of alternative care options. Clinical Practice Guidelines We Can Trust examines the current state of clinical practice guidelines and how they can be improved to enhance healthcare quality and patient outcomes. Clinical practice guidelines now are ubiquitous in our healthcare system. The Guidelines International Network (GIN) database currently lists more than 3,700 guidelines from 39 countries. Developing guidelines presents a number of challenges including lack of transparent methodological practices, difficulty reconciling conflicting guidelines, and conflicts of interest. Clinical Practice Guidelines We Can Trust explores questions surrounding the quality of CPG development processes and the establishment of standards. It proposes eight standards for developing trustworthy clinical practice guidelines emphasizing transparency; management of conflict of interest ; systematic review--guideline development intersection; establishing evidence foundations for and rating strength of guideline recommendations; articulation of recommendations; external review; and updating. Clinical Practice Guidelines We Can Trust shows how clinical practice guidelines can enhance clinician and patient decision-making by translating complex scientific research findings into recommendations for clinical practice that are relevant to the individual patient encounter, instead of implementing a one size fits all approach to patient care. This book contains information directly related to the work of the Agency for Healthcare Research and Quality (AHRQ

Novel Designs of Early Phase Trials for Cancer Therapeutics Book

Novel Designs of Early Phase Trials for Cancer Therapeutics


  • Author : Shivaani Kummar
  • Publisher : Academic Press
  • Release Date : 2018-05-22
  • Genre: Medical
  • Pages : 234
  • ISBN 10 : 9780128125700

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Novel Designs of Early Phase Trials for Cancer Therapeutics Excerpt :

Novel Designs of Early Phase Trials for Cancer Therapeutics provides a comprehensive review by leaders in the field of the process of drug development, the integration of molecular profiling, the changes in early phase trial designs, and endpoints to optimally develop a new generation of cancer therapeutics. The book discusses topics such as statistical perspectives on cohort expansions, the role and application of molecular profiling and how to integrate biomarkers in early phase trials. Additionally, it discusses how to incorporate patient reported outcomes in phase one trials. This book is a valuable resource for medical oncologists, basic and translational biomedical scientists, and trainees in oncology and pharmacology who are interested in learning how to improve their research by using early phase trials. Brings a comprehensive review and recommendations for new clinical trial designs for modern cancer therapeutics Provides the reader with a better understanding on how to design and implement early phase oncology trials Presents a better and updated understanding of the process of developing new treatments for cancer, the exciting scientific advances and how they are informing drug development

Principles and Practice of Clinical Trial Medicine Book
Score: 4.5
From 2 Ratings

Principles and Practice of Clinical Trial Medicine


  • Author : Richard Chin
  • Publisher : Elsevier
  • Release Date : 2008-07-25
  • Genre: Medical
  • Pages : 560
  • ISBN 10 : 0080557937

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Principles and Practice of Clinical Trial Medicine Excerpt :

Clinical trials are an important part of medicine and healthcare today, deciding which treatments we use to treat patients. Anyone involved in healthcare today must know the basics of running and interpreting clinical trial data. Written in an easy-to-understand style by authors who have considerable expertise and experience in both academia and industry, Principles and Practice of Clinical Trial Medicine covers all of the basics of clinical trials, from legal and ethical issues to statistics, to patient recruitment and reporting results. Jargon-free writing style enables those with less experience to run their own clinical trials and interpret data Book contains an ideal mix of theory and practice so researchers will understand both the rationale and logistics to clinical trial medicine Expert authorship whose experience includes running clinical trials in an academic as well as industry settings Numerous illustrations reinforce and elucidate key concepts and add to the book's overall pedagogy

The Law of Off label Uses of Medicines Book

The Law of Off label Uses of Medicines


  • Author : Andrea Parziale
  • Publisher : Taylor & Francis
  • Release Date : 2022-08-12
  • Genre: Law
  • Pages : 224
  • ISBN 10 : 9781000634389

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The Law of Off label Uses of Medicines Excerpt :

This book examines the regulatory framework for untested and unapproved uses (off-label uses) of medicines in the EU, UK, and USA. Before reaching patients, medicines are extensively tested by manufacturers and approved by regulators to minimise the risk of adverse reactions. However, physicians can prescribe pharmaceuticals for off-label uses, widespread in paediatrics, oncology, rare diseases and, more recently, in treatment for Covid-19. While off-label uses may offer hope, they may also expose patients to risks and uncertainties. Clarification is therefore needed to improve the protection of patients' rights while enhancing legal certainty for health actors. To this end, this work clarifies the regulatory mechanisms and litigation trends concerning off-licence prescriptions in these jurisdictions. It assesses how traditional, prevention-driven regulatory and civil liability rules are being adapted to tackle potential risks and scientific uncertainty. The book outlines the applicable regulations, as well as considering Brexit’s impact on off-label policies in the UK, and EU and national off-label policies in the context of the fight against the Covid-19 pandemic. It also explores under what conditions physicians, manufacturers, or regulators must compensate patients injured by untested prescriptions. The book will be an essential resource for researchers, academics and policy-makers working in the areas of medical law and ethics, public health law, pharmaceutical law and private comparative law.

The Practical Playbook Book

The Practical Playbook


  • Author : J. Lloyd Michener
  • Publisher : Oxford University Press, USA
  • Release Date : 2016
  • Genre: Medical
  • Pages : 401
  • ISBN 10 : 9780190222147

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The Practical Playbook Excerpt :

Why a practical playbook for partnerships between public health and primary care? / Denise Koo, J. Lloyd Michener, James B. Sprague, Brian C. Castrucci -- The value of public health and primary care partnerships / Brian C. Castrucci, J. Lloyd Michener, Densie Koo, James B. Sprague -- Primary care and public health: partners for population health / Julie K. Wood -- The value of integration : public health, primary care, and beyond / Paul E. Jarris, Katie Sellers -- Principles of partnerships between public health and primary care / J. Lloyd Michener, Brian C. Castrucci, Denise Koo -- Stages of partnerships between public health and primary care / J. Lloyd Michener, Brian C. Castrucci -- How to have difficult conversations / Justine Strand de Oliveira -- Group dynamics / Mina Silberberg, Seamus Bhatt-Mackin -- Pitching your project / Justine Strand de Oliveira -- Positioned for sustainability / Karen J. Minyard, Amanda Phillips Martinez, Tanisa Adimu -- The role of early wins in long-term success / Frederick S. Johnson -- The value of early wins in be well Lake County / Christina Arnold -- Challenges of working together / Lara Snyder -- Starting off on the right foot: a communication strategy is essential / Karen Remley -- Leveraging media / Kate Reuterswärd -- The practice of public health and how it is changing / Brian C. Castrucci, Hugh H. Tilson, Denise Koo, Jonathon P. Leider -- The changing landscape of primary care / Andrew Bazemore, Russell Phillips, Robert L. Phillips, Jr -- Addressing social determinants of health / Mina Silberberg, Brian C. Castrucci -- Creating a culture of health in Cambridge, MA / Claude-Alix Jacob, Susan Feinberg -- Community health assessments : past, present, and future / Kevin Barnett, Sara Rosenbaum -- Community health needs assessments benefit communities and hospitals alike / Philip Alberti, Ivy Baer -- Leveraging the affordable care act for population health / Eduardo Sanchez -- Partnering with Medicaid, Medicare, public health,

The Role of the Pharmacist in Patient Care Book
Score: 4
From 15 Ratings

The Role of the Pharmacist in Patient Care


  • Author : Abdul Kader Mohiuddin
  • Publisher : Universal-Publishers
  • Release Date : 2020
  • Genre: Medical
  • Pages : 690
  • ISBN 10 : 9781627343084

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The Role of the Pharmacist in Patient Care Excerpt :

The goal of a high quality, cost-effective and accessible health care for patients is achieved through constructing a team-based and patient-centered health care delivery system. The expanded role of pharmacists uplifts them to patient care from dispensing and manufacturing or marketing of drugs. Along with doctors and allied health professionals, pharmacists are increasingly recognized as an integral part of the patient care team. Furthermore, colleges of pharmacy need to revise and up-date their curricula to accommodate the progressively increasing development in the pharmaceutical education and the evolving new roles of practicing pharmacists in patient care settings. This book focuses on the expanded role of the pharmacists in total patient care including prescribing, dispensing, compounding, administering and monitoring of drugs at home, hospital, community, hospice, critical care, changeover and other care settings. The sector is emerging in both developed and under-developed countries. Overburdened by patient loads and the explosion of new drugs physicians turned to pharmacists more and more for drug information especially within institutional settings. And today’s patient care pharmacists are taking more interests in medication review and reconciliation, patient education and counseling, creating drug therapy regimen and monitoring compliance. The purpose of this book is to guide the pharmacists in their daily interactions with patients and to ensure collaboration with other health professionals. The contents are mostly based on recently published articles related to patient care, with most recent ideas and activities followed by the patient care pharmacists around the globe. However, a pharmacist implements the care plan in collaboration with other health care professionals and the patient or caregiver. Along with professional guidelines, the book discusses the concepts and best practices of patient interaction, patient rights, and ethical decision-making

Nutrients in Infancy Book

Nutrients in Infancy


  • Author : Colin Binns
  • Publisher : MDPI
  • Release Date : 2018-07-04
  • Genre: Electronic book
  • Pages : 449
  • ISBN 10 : 9783038425601

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Nutrients in Infancy Excerpt :

This book is a printed edition of the Special Issue "Nutrients in Infancy" that was published in Nutrients

The Practical Playbook II Book

The Practical Playbook II


  • Author : J. Lloyd Michener
  • Publisher : Oxford University Press
  • Release Date : 2019-04-23
  • Genre: Medical
  • Pages : 400
  • ISBN 10 : 9780190936020

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The Practical Playbook II Excerpt :

The definitive guide to the secret sauce of improving public and population health Nontraditional collaborations have produced some of the most sweeping, health-improving results in recent memory. But whether it's public/private, cross-discipline, or interagency, the formula for identifying these partnerships -- not to mention making them work -- remains very much in progress. The Practical Playbook II is the first resource to elucidate what works (and what doesn't) when it comes to collaborating for change in and around health. It brings together voices of experience and authority to answer this topic's most challenging questions and provide guideposts for applying what they've learned to today's thorniest problems. Readers will find answers to common and advanced questions around multisector partnerships, including: · Identifying sectors and actors that can help to collaborate to improve health · Best practices for initial engagement · Specifics related to collaborations with government, business, faith communities, and other types of partners · The role of data in establishing and running a partnership · Scaling up to maximize impact and remain sustainable · The role of financing · Implications for policy Written in practical terms that will resonate with readers from any background and sector, The Practical Playbook II is the resource that today's helping professions need -- and a roadmap for the next generation of health-improving partnerships.