Becoming A Successful Clinical Trial Investigator
Author : P. K. Julka
Publisher : Dna Press
Page : 172 pages
File Size : 50,75 MB
Release : 2009*
Category :
ISBN : 8190827707
Sharing Clinical Trial Data
Author : Institute of Medicine
Publisher : National Academies Press
Page : 236 pages
File Size : 10,98 MB
Release : 2015-04-20
Category : Medical
ISBN : 0309316324
Book Description
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.
Small Clinical Trials
Author : Institute of Medicine
Publisher : National Academies Press
Page : 221 pages
File Size : 31,70 MB
Release : 2001-01-01
Category : Medical
ISBN : 0309171148
Book Description
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.
A Practical Guide to Managing Clinical Trials
Author : JoAnn Pfeiffer
Publisher : CRC Press
Page : 292 pages
File Size : 34,29 MB
Release : 2017-05-18
Category : Mathematics
ISBN : 1315299771
Book Description
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.
Transforming Clinical Research in the United States
Author : Institute of Medicine
Publisher : National Academies Press
Page : 151 pages
File Size : 39,41 MB
Release : 2010-10-22
Category : Medical
ISBN : 0309163358
Book Description
An ideal health care system relies on efficiently generating timely, accurate evidence to deliver on its promise of diminishing the divide between clinical practice and research. There are growing indications, however, that the current health care system and the clinical research that guides medical decisions in the United States falls far short of this vision. The process of generating medical evidence through clinical trials in the United States is expensive and lengthy, includes a number of regulatory hurdles, and is based on a limited infrastructure. The link between clinical research and medical progress is also frequently misunderstood or unsupported by both patients and providers. The focus of clinical research changes as diseases emerge and new treatments create cures for old conditions. As diseases evolve, the ultimate goal remains to speed new and improved medical treatments to patients throughout the world. To keep pace with rapidly changing health care demands, clinical research resources need to be organized and on hand to address the numerous health care questions that continually emerge. Improving the overall capacity of the clinical research enterprise will depend on ensuring that there is an adequate infrastructure in place to support the investigators who conduct research, the patients with real diseases who volunteer to participate in experimental research, and the institutions that organize and carry out the trials. To address these issues and better understand the current state of clinical research in the United States, the Institute of Medicine's (IOM) Forum on Drug Discovery, Development, and Translation held a 2-day workshop entitled Transforming Clinical Research in the United States. The workshop, summarized in this volume, laid the foundation for a broader initiative of the Forum addressing different aspects of clinical research. Future Forum plans include further examining regulatory, administrative, and structural barriers to the effective conduct of clinical research; developing a vision for a stable, continuously funded clinical research infrastructure in the United States; and considering strategies and collaborative activities to facilitate more robust public engagement in the clinical research enterprise.
Envisioning a Transformed Clinical Trials Enterprise in the United States
Author : Institute of Medicine
Publisher : National Academies Press
Page : 248 pages
File Size : 37,46 MB
Release : 2012-09-13
Category : Medical
ISBN : 0309253187
Book Description
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.
The Prevention and Treatment of Missing Data in Clinical Trials
Author : National Research Council
Publisher : National Academies Press
Page : 163 pages
File Size : 47,41 MB
Release : 2010-12-21
Category : Medical
ISBN : 030918651X
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.
Women in Ophthalmology
Author : Christina Y. Weng
Publisher : Springer Nature
Page : 366 pages
File Size : 23,96 MB
Release : 2021-03-02
Category : Medical
ISBN : 3030593355
Book Description
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.
Crossing the Quality Chasm
Author : Institute of Medicine
Publisher : National Academies Press
Page : 359 pages
File Size : 18,48 MB
Release : 2001-07-19
Category : Medical
ISBN : 0309132967
Book Description
Second in a series of publications from the Institute of Medicine's Quality of Health Care in America project Today's health care providers have more research findings and more technology available to them than ever before. Yet recent reports have raised serious doubts about the quality of health care in America. Crossing the Quality Chasm makes an urgent call for fundamental change to close the quality gap. This book recommends a sweeping redesign of the American health care system and provides overarching principles for specific direction for policymakers, health care leaders, clinicians, regulators, purchasers, and others. In this comprehensive volume the committee offers: A set of performance expectations for the 21st century health care system. A set of 10 new rules to guide patient-clinician relationships. A suggested organizing framework to better align the incentives inherent in payment and accountability with improvements in quality. Key steps to promote evidence-based practice and strengthen clinical information systems. Analyzing health care organizations as complex systems, Crossing the Quality Chasm also documents the causes of the quality gap, identifies current practices that impede quality care, and explores how systems approaches can be used to implement change.
Guide for Investigator Initiated Trials
Author : Gerhard Fortwengel
Publisher : Karger Medical and Scientific Publishers
Page : 189 pages
File Size : 42,17 MB
Release : 2011
Category : Medical
ISBN : 3805596847
Book Description
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.
