Download or read book Investigator Initiated Trials Simplified written by T. C. George and published by Createspace Independent Publishing Platform. This book was released on 2016-12-01 with total page 106 pages. Available in PDF, EPUB and Kindle. Book excerpt: This book is designed to serve as a guide for the clinical trial investigator who is willing to initiate clinical study from their own. The chapters include Basics of IITs, IIT and Regulation, IIT and Association with Industry, Protocol Designing, Budget Preparation, Case Report Form, Informed Consent, Reporting, Clinical Trial Registration, EC Submission, Conduct and Monitoring, Data Management, CSR Preparation etc. Each chapter is thoughtfully developed to simplify the job of a clinical trial investigator.
Download or read book Sharing Clinical Trial Data written by Institute of Medicine and published by National Academies Press. This book was released on 2015-04-20 with total page 304 pages. Available in PDF, EPUB and Kindle. Book excerpt: Data sharing can accelerate new discoveries by avoiding duplicative trials, stimulating new ideas for research, and enabling the maximal scientific knowledge and benefits to be gained from the efforts of clinical trial participants and investigators. At the same time, sharing clinical trial data presents risks, burdens, and challenges. These include the need to protect the privacy and honor the consent of clinical trial participants; safeguard the legitimate economic interests of sponsors; and guard against invalid secondary analyses, which could undermine trust in clinical trials or otherwise harm public health. Sharing Clinical Trial Data presents activities and strategies for the responsible sharing of clinical trial data. With the goal of increasing scientific knowledge to lead to better therapies for patients, this book identifies guiding principles and makes recommendations to maximize the benefits and minimize risks. This report offers guidance on the types of clinical trial data available at different points in the process, the points in the process at which each type of data should be shared, methods for sharing data, what groups should have access to data, and future knowledge and infrastructure needs. Responsible sharing of clinical trial data will allow other investigators to replicate published findings and carry out additional analyses, strengthen the evidence base for regulatory and clinical decisions, and increase the scientific knowledge gained from investments by the funders of clinical trials. The recommendations of Sharing Clinical Trial Data will be useful both now and well into the future as improved sharing of data leads to a stronger evidence base for treatment. This book will be of interest to stakeholders across the spectrum of research--from funders, to researchers, to journals, to physicians, and ultimately, to patients.
Download or read book Guide for Investigator Initiated Trials written by Gerhard Fortwengel and published by Karger Medical and Scientific Publishers. This book was released on 2011 with total page 189 pages. Available in PDF, EPUB and Kindle. Book excerpt: An essential manual for beginners and senior researchers alike For academic medical faculty unfamiliar with national and international regulations, the prospect of initiating and managing a clinical trial can be intimidating. The development of protocols and case report forms, compliance with regulatory requirements, the monitoring of clinical trials as well as the responsibilities of documentation are just some of the tasks the sponsor-investigator is faced with. This book covers the entire spectrum of a clinical trial, reviewing the different stages step by step: financial planning, crucial aspects of trial design, the authorization process and, finally, documentation. Moreover, it contains helpful tips, a practical glossary, instructions and a large number of resources related to the relevant regulations and forms conforming to the International Conference on Harmonization and Good Clinical Practice'. This makes the publication at hand an essential cookbook' for both academic faculty new to clinical trials as well as seasoned sponsors-investigators.
Download or read book Implementing a National Cancer Clinical Trials System for the 21st Century written by Institute of Medicine and published by National Academies Press. This book was released on 2011-10-19 with total page 122 pages. Available in PDF, EPUB and Kindle. Book excerpt: Clinical trials enable scientific discoveries to advance patient care, in addition to informing and guiding subsequent research. The National Cancer Institute's (NCI's) Clinical Trials Cooperative Group Program works to advance patient care and research. The Cooperative Group Program has been instrumental in establishing the standards for cancer patient care and clinical research methods. Despite broad participation in the program, financial strain and procedural burdens limit the ability of the Cooperative Group Program to undertake medical practice-changing clinical research. Thus, the Institute of Medicine's (IOM's) National Cancer Policy Forum and the American Society of Clinical Oncology held a workshop on March 21, 2011 to follow up on the 2010 IOM report, A National Clinical Trials System for the 21st Century: Reinvigorating the NCI Cooperative Group Program, which made recommendations to strengthen the NCI Cooperative Group Program. In keeping with the established commitment to excellence Implementing a National Cancer Clinical Trials System for the 21st Century outlines how to improve the current system by incorporating innovative science and trial design into cancer clinical trials. It also examines the impact of increasing quality in regards to speed, efficiency, design, launch, and conduct, as well as improving prioritization, and incentivized participation.
Download or read book Global Environmental Change written by National Research Council and published by National Academies Press. This book was released on 1991-02-01 with total page 321 pages. Available in PDF, EPUB and Kindle. Book excerpt: Global environmental change often seems to be the most carefully examined issue of our time. Yet understanding the human sideâ€"human causes of and responses to environmental changeâ€"has not yet received sustained attention. Global Environmental Change offers a strategy for combining the efforts of natural and social scientists to better understand how our actions influence global change and how global change influences us. The volume is accessible to the nonscientist and provides a wide range of examples and case studies. It explores how the attitudes and actions of individuals, governments, and organizations intertwine to leave their mark on the health of the planet. The book focuses on establishing a framework for this new field of study, identifying problems that must be overcome if we are to deepen our understanding of the human dimensions of global change, presenting conclusions and recommendations.
Download or read book Becoming A Successful Clinical Trial Investigator written by P. K. Julka and published by Dna Press. This book was released on 2009* with total page 172 pages. Available in PDF, EPUB and Kindle. Book excerpt:
Download or read book Quality in Nuclear Medicine written by Andor W.J.M. Glaudemans and published by Springer. This book was released on 2016-11-14 with total page 466 pages. Available in PDF, EPUB and Kindle. Book excerpt: This comprehensive textbook provides a state of the art overview of the means by which quality in patient care is ensured within the field of nuclear medicine. Acknowledged experts in the field cover both management aspects, such as laws, standards, guidelines, patient safety, management instruments, and organisations, and specific issues, including radiation safety and equipment. Quality in Nuclear Medicine not only presents detailed information on the topics discussed but should also stimulate further discussion and offer an important tool to all professionals in the field of nuclear medicine and their stakeholders. Readers will find that the book provides a wealth of excellent guidance and reflects the pioneering role of nuclear medicine in advancing different aspects of quality within medicine.
Download or read book Supply Chain Planning for Clinical Trials written by Ryan Mills and published by John Wiley & Sons. This book was released on 2024-07-03 with total page 501 pages. Available in PDF, EPUB and Kindle. Book excerpt: Ensure your clinical trial supply chain is running smoothly with this practical guide Clinical trials are a critical part of the pharmaceutical development process. These trials cannot proceed without timely and regular receipt of the drugs being tested, which can prove a challenge for drug manufacturers who have not yet established the structures required to produce quality-controlled specimens of the drug at scale. Managing supply chains of pre-production drugs for clinical trials is therefore an essential component of drug development. Supply Chain Planning for Clinical Trials offers a practical introduction to this process for researchers and industry professionals. Beginning with the basics of clinical trial supply chain management, it proceeds step by step through all aspects of demand and supply planning for clinical trials. The result is a thorough overview that also offers practical examples of how to plan supply for clinical trials. Supply Chain Planning for Clinical Trials readers will also find: Tools for minimizing risk and expense by optimizing the relationship between supply and demand Detailed discussion of topics including quality and regulatory considerations and the business processes that support clinical trial supply chain management Spreadsheet-based models to illustrate key concepts, adaptable to the readers’ specific scenarios Supply Chain Planning for Clinical Trails is ideal for pharmaceutical industry professionals involved in clinical trial supply planning, as well as academics and researchers interested in the pharmaceutical industry and its logistics.
Download or read book The 800 Million Pill written by Merrill Goozner and published by Univ of California Press. This book was released on 2005-10-10 with total page 308 pages. Available in PDF, EPUB and Kindle. Book excerpt: "Goozner shows how drug innovation is driven by dedicated scientists intent on finding cures for diseases, not by pharmaceutical firms, whose bottom line often takes precedence over the advance of medicine. Stories of a university biochemist who spent twenty years searching for single blood protein that later became the best-selling biotech drug in the world, a government employee who discovered the causes for dozens of crippling genetic disorders, and the Department of Energy-funded research that made the Human Genome Project possible - these accounts illustrate how medical breakthroughs actually take place.".
Download or read book ClinicalTrials written by Curtis L. Meinert PhD and published by Oxford University Press. This book was released on 2012-02-17 with total page 720 pages. Available in PDF, EPUB and Kindle. Book excerpt: First published in 1986, this landmark text is the definitive guide to clinical trials, written by one of the leading experts in the field. This fully-updated second edition continues to be the most authoritative reference text on randomized clinical trials. It contains a wealth of practical information on the design, conduct, and analysis of both single center and multicenter trials. No other book on clinical trials offers as much detail on such issues as sample size calculation, stratification and randomization, data systems design, development of consent forms, publication policies, preparation of funding requests, and reporting procedures. While the basics of design, conduct, and analysis of clinical trials remain the same, there have been significant changes since the first edition of Clinical Trials was published two decades ago. In this new edition, the author discusses the refinements and improvements made to methods and procedures, changes in the policies and guidelines underlying trials, as well as requirements for registration of trials. He also discusses current practices for data sharing, for gender representation, for treatment effects monitoring, and for ethical standards of clinical trials. The importance of the randomized controlled trial has grown significantly over time and they are now the cornerstone of all evidence-based medicine. Still rich in tables, checklists, charts, and other resources for the trialist, the second edition of Clinical Trials is an indispensable reference for clinicians, biostaticians, epidemiologists, and anyone involved in the design and implementation of a clinical trial.
Download or read book Charting The Course Priorities For Breast Cancer Research Report Of The Breast Cancer Progress Review Group August 1998 written by and published by . This book was released on 2000 with total page 156 pages. Available in PDF, EPUB and Kindle. Book excerpt:
Download or read book The Sourcebook for Clinical Research written by Natasha Martien and published by Academic Press. This book was released on 2018-08-01 with total page 278 pages. Available in PDF, EPUB and Kindle. Book excerpt: A single trial is complex, with numerous regulations, administrative processes, medical procedures, deadlines and specific protocol instructions to follow. And yet, there has existed no single-volume, comprehensive clinical research reference manual for investigators, medical institutions, and national and international research personnel to keep on the shelf as a ready reference to navigate through trial complexities and ensure compliance with U.S. Federal Regulations and ICH GCP until The Sourcebook for Clinical Research. An actionable, step-by-step guide through beginning to advanced topics in clinical research with forms, templates and checklists to download from a companion website, so that study teams will be compliant and will find all the necessary tools within this book. Additionally, the authors developed Display Posters for Adverse Events Plus Reporting and Medicare Coverage Analysis that can be purchased separately here: https://www.elsevier.com/books-and-journals/book-companion/9780128162422/order-display-posters. Moreover, The Sourcebook for Clinical Research contains clear information and guidance on the newest changes in the industry to keep seasoned investigators and staff current and compliant, in addition to providing detailed information regarding the most complex topics. This book serves as a quick, actionable, off-the-shelf resource to keep by your side at the medical clinic. Makes vital trial conduct information easy to understand and instructs on how to practically apply current Federal regulations and Good Clinical Practice (ICH GCP) Offers extensive guidance that is crucial for guaranteeing compliance to clinical research regulations during each step of the clinical research process Provides up-to-date and extensive coverage of beginning to advanced topics, and, step-by-step actions to take during exceptional circumstances, including compassionate use, emergency use, human subjects protections for vulnerable populations, and federal audits Furnishes a detailed clinical research Glossary, and a comprehensive Appendix containing ready-to-use forms, templates, and checklists for clinical trial personnel to download and begin using immediately. Written for the fast-paced clinic environment with action steps and forms in the book to respond to a research subject’s needs urgently and compliantly
Download or read book Meeting the Nation s Needs for Biomedical and Behavioral Scientists written by National Research Council and published by National Academies Press. This book was released on 1994-02-01 with total page 106 pages. Available in PDF, EPUB and Kindle. Book excerpt: On May 3, 1993, the National Research Council's (NRC) Committee on National Needs for Biomedical and Behavioral Research Personnel convened a public hearing to gather the views of colleagues on the future direction of the National Research Service Awards (NRSA) program. In preparation for the hearing, the committee formulated a set of questions to be addressed by respondents and consulted with the staff of the National Institutes of Health in compiling a list of individuals and organizations to whom a letter soliciting a response to those questions could be sent. (See Appendix A.) A letter posing the following four questions was sent to over 1,000 individuals: What is the most significant challenge we face today in the United States in maintaining an adequate supply of qualified scientists to sustain and advance health research? What improvements might be made in the National Research Service Awards (NRSA) program to assure a continuing supply of skilled investigators in the biomedical and behavioral sciences in the coming years? What steps might be taken to improve the effectiveness of the NRSA program in recruiting women and minorities into scientific careers? What features of the NRSA training grant might be strengthened to assure the maintenance of high quality research training environments?
Download or read book Charting the Course written by National Cancer Institute (U.S.). Breast Cancer Progress Review Group and published by . This book was released on 1998 with total page 152 pages. Available in PDF, EPUB and Kindle. Book excerpt:
Download or read book T Bytes Platforms Applications written by IT-Shades and published by EGBG Services LLC. This book was released on 2020-10-02 with total page 184 pages. Available in PDF, EPUB and Kindle. Book excerpt: This document brings together a set of latest data points and publicly available information relevant for Platforms & Applications This document brings together a set of latest data points and publicly available information relevant for Platforms & Applications periodic publication immensely.
Download or read book T Byte Platforms Applications written by IT-Shades and published by EGBG Services LLC. This book was released on 2020-01-29 with total page 99 pages. Available in PDF, EPUB and Kindle. Book excerpt: This document brings together a set of latest data points and publicly available information relevant for Platforms & Applications. We are very excited to share this content and believe that readers will benefit immensely from this periodic publication immensely.
Download or read book Reviewing Clinical Trials written by Chinese University of Hong Kong and published by . This book was released on 2010 with total page 153 pages. Available in PDF, EPUB and Kindle. Book excerpt: The idea for this manual came from Pfizer in the US, which provided the Clinical Trials Centre at The University of Hong Kong, Hong Kong SAR, PR China with a nonbinding grant for its development. The general project layout protocol was accepted by Pfizer in July 2009. Pfizer has not in any way interfered with the project, except for providing nonbinding comments to the final product. The entire text of this manual was written by Johan PE Karlberg. Marjorie A Speers provided considerable and essential comments on the contents and the first and subsequent drafts. A group of international human research protection experts mostly working in non-profit institutions or organisations - see Contributors for details - reviewed and provided important comments on the contents and final draft. It was solely created with the intention to promote human research protection of participants in clinical trials. This manual will be translated into numerous languages and is provided free of charge as an electronic file over the Internet (http://www.ClinicalTrialMagnifier.com) and offered in print for a fee. The objective beyond this project is to establish educational activities, developed around the manual, and jointly organised with leading academic institutions worldwide.
