Becoming A Successful Clinical Trial Investigator
Author: P. K. Julka
Publisher: Dna Press
Published: 2009*
Total Pages: 172
ISBN-13: 8190827707
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Becoming a Successful Clinical Research Investigator
Author: David Ginsberg
Publisher:
Published: 2009-01-01
Total Pages: 396
ISBN-13: 9781930624481
DOWNLOAD EBOOK →A Practical Guide to Managing Clinical Trials
Author: JoAnn Pfeiffer
Publisher: CRC Press
Published: 2017-05-18
Total Pages: 292
ISBN-13: 1315299771
DOWNLOAD EBOOK →A Practical Guide to Managing Clinical Trials is a basic, comprehensive guide to conducting clinical trials. Designed for individuals working in research site operations, this user-friendly reference guides the reader through each step of the clinical trial process from site selection, to site set-up, subject recruitment, study visits, and to study close-out. Topics include staff roles/responsibilities/training, budget and contract review and management, subject study visits, data and document management, event reporting, research ethics, audits and inspections, consent processes, IRB, FDA regulations, and good clinical practices. Each chapter concludes with a review of key points and knowledge application. Unique to this book is "A View from India," a chapter-by-chapter comparison of clinical trial practices in India versus the U.S. Throughout the book and in Chapter 10, readers will glimpse some of the challenges and opportunities in the emerging and growing market of Indian clinical trials.
Envisioning a Transformed Clinical Trials Enterprise in the United States
Author: Institute of Medicine
Publisher: National Academies Press
Published: 2012-09-13
Total Pages: 248
ISBN-13: 0309253187
DOWNLOAD EBOOK →There is growing recognition that the United States' clinical trials enterprise (CTE) faces great challenges. There is a gap between what is desired - where medical care is provided solely based on high quality evidence - and the reality - where there is limited capacity to generate timely and practical evidence for drug development and to support medical treatment decisions. With the need for transforming the CTE in the U.S. becoming more pressing, the IOM Forum on Drug Discovery, Development, and Translation held a two-day workshop in November 2011, bringing together leaders in research and health care. The workshop focused on how to transform the CTE and discussed a vision to make the enterprise more efficient, effective, and fully integrated into the health care system. Key issue areas addressed at the workshop included: the development of a robust clinical trials workforce, the alignment of cultural and financial incentives for clinical trials, and the creation of a sustainable infrastructure to support a transformed CTE. This document summarizes the workshop.
Small Clinical Trials
Author: Institute of Medicine
Publisher: National Academies Press
Published: 2001-01-01
Total Pages: 221
ISBN-13: 0309171148
DOWNLOAD EBOOK →Clinical trials are used to elucidate the most appropriate preventive, diagnostic, or treatment options for individuals with a given medical condition. Perhaps the most essential feature of a clinical trial is that it aims to use results based on a limited sample of research participants to see if the intervention is safe and effective or if it is comparable to a comparison treatment. Sample size is a crucial component of any clinical trial. A trial with a small number of research participants is more prone to variability and carries a considerable risk of failing to demonstrate the effectiveness of a given intervention when one really is present. This may occur in phase I (safety and pharmacologic profiles), II (pilot efficacy evaluation), and III (extensive assessment of safety and efficacy) trials. Although phase I and II studies may have smaller sample sizes, they usually have adequate statistical power, which is the committee's definition of a "large" trial. Sometimes a trial with eight participants may have adequate statistical power, statistical power being the probability of rejecting the null hypothesis when the hypothesis is false. Small Clinical Trials assesses the current methodologies and the appropriate situations for the conduct of clinical trials with small sample sizes. This report assesses the published literature on various strategies such as (1) meta-analysis to combine disparate information from several studies including Bayesian techniques as in the confidence profile method and (2) other alternatives such as assessing therapeutic results in a single treated population (e.g., astronauts) by sequentially measuring whether the intervention is falling above or below a preestablished probability outcome range and meeting predesigned specifications as opposed to incremental improvement.
The Fundamentals of Clinical Research
Author: P. Michael Dubinsky
Publisher: John Wiley & Sons
Published: 2022-01-26
Total Pages: 554
ISBN-13: 1118949595
DOWNLOAD EBOOK →This book focuses on the practical application of good clinical practice (GCP) fundamentals and provides insight into roles and responsibilities included in planning, executing, and analyzing clinical trials. The authors describe the design of quality into clinical trial planning and the application of regulatory, scientific, administrative, business, and ethical considerations. Describes the design of quality into the clinical trial planning Has end-of-chapter questions and answers to check learning and comprehension Includes charts that visually summarize the content and allow readers to cross-reference details in relevant chapters Offers a companion website containing supplemental training resources
Sharing Clinical Trial Data
Author: Institute of Medicine
Publisher: National Academies Press
Published: 2015-04-20
Total Pages: 236
ISBN-13: 0309316324
DOWNLOAD EBOOK →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.
15 Golden Clinical Trial Practices for Investigators
Author: S. Fernandez
Publisher: CreateSpace
Published: 2014-08-15
Total Pages: 76
ISBN-13: 9781500913908
DOWNLOAD EBOOK →This book focus on 15 essential clinical trial practices which must be followed by an Investigator. These 15 practices have been divided into 3 phases: Before Initiating a Trial, During Conduction of Trial and After Completion or Termination of Trial. The book covers essential elements which investigator needs to follow in a trial like: Contracts and Agreements, Constitution and Training of Study Team, Procurement of Equipment's, Compliance, Medical Care and Protection of Study Subjects, Recruitment, Recording Data, IP Accountability, SAE Reporting, Documentations, Data Verification, Communication, Financial Tracking, Archival etc.
Women in Ophthalmology
Author: Christina Y. Weng
Publisher: Springer Nature
Published: 2021-03-02
Total Pages: 366
ISBN-13: 3030593355
DOWNLOAD EBOOK →There are nearly 24,000 ophthalmologists in the United States, with 500 physicians newly entering the ophthalmology field each year and approximately half of those being women. Although women now represent approximately half of all ophthalmologists, gender disparities remain when it comes to certain subspecialties (e.g., surgical retina), leadership roles (e.g., department chairs), industry involvement (e.g., consultancy and advisory board positions), and even academic publications. There has been a recently heightened interest in female representation in this field which has manifested in several ways (e.g., conferences geared towards women in ophthalmology, non-peer-reviewed publications about women in ophthalmology, and mentorship programs specifically for women). This book is the first of its kind in procuring and disseminating information—pertaining to both career and life—in an organized, concrete, and enduring way. Women in Ophthalmology is a comprehensive collection of chapters primarily written by women in the field of ophthalmology. The book aims to guide others through milestones and challenges women may face during their careers, and shares sound insights into how to deal with unique issues both inside and outside the workplace. Topics that are widely applicable to all who work in ophthalmology are included, such as finding mentors, collaborating within industry, handling work-life balance, and seeking out leadership opportunities. Each chapter combines personal anecdotes with knowledge from leaders in the field which both men and women will find highly valuable.
The Investigator's Guide to Clinical Research
Author: David Ginsberg
Publisher:
Published: 2002
Total Pages: 324
ISBN-13:
DOWNLOAD EBOOK →The Investigator's Guide to Clinical Research is a step-by-step manual filled with tips, instructions and insights for investigators - novice and experienced - and health professionals involved in conducting clinical research. Along with updated sections, charts and statistics, the 3rd edition includes a detailed look at investigator financial disclosure, noncompliance issues, the FDA audit process and data collection technologies. A new appendix includes valuable lists of company contacts and additional resources. Developed in accordance with the essentials and standards of the ACCME. Exam is provided online. Topics include...An overview of the clinical development process; A review of regulatory requirements; How to set up and manage a research center; How to effectively and efficiently conduct clinical trials and How to identify and secure clinical grant opportunities.
