May. 15, 2013 -- Researchers who have been reporting success with the use of fecal transplant to treat resistant C. difficile are likely to need an OK from the the FDA to continue that treatment.
Apr. 18, 2013 -- A consumer group's attack on a study published in 2010 in the ALLNew England Journal of Medicine drew a sharp response this week from the journal's top editors and the study's lead authors.
Apr. 10, 2013 -- Public Citizen, the watchdog group founded by Ralph Nader, today demanded an apology from Kathleen Sebelius, secretary of the Department of Health and Human Services (HHS), for what it termed HHS mishandling of informed consent in a federally-funded study evaluating oxygen saturation targets in premature infants.
Mar. 26, 2013 -- Results of the troubled TACT randomized clinical trial do not support the routine application of chelation therapy in patients who've had a previous heart attack, researchers found.
Mar. 20, 2013 -- The negative results of three randomized trials should have closed the book on patent foramen ovale closure in cryptogenic stroke, but the book is still being read.
Mar. 19, 2013 -- WASHINGTON -- FDA reviewers slammed the design of the MitraClip pivotal study and issued generally negative reviews in briefing documents prepared for Wednesday's advisory committee review of the device.
Mar. 9, 2013 -- Cardiologists meeting in San Francisco were told that extended-release niacin has no measurable benefits in heart disease and many risks. But niacin is not the only popular treatment that piles up profits without proof.
Mar. 1, 2013 -- The FDA has sent a warning letter to an investigator in the pivotal U.S. trial of the Medtronic CoreValve percutaneous aortic valve citing a number of violations.
Feb. 27, 2013 -- A highly significant increase in adverse events, in particular myopathy, appears to have been a driving force behind the decision to shut down a pivotal trial of Tredaptive, the agent that many hoped would improve niacin tolerance.
Feb. 26, 2013 -- The FDA today suspended all pediatric clinical trials of cinacalcet hydrochloride (Sensipar) -- Amgen's calcium-sensing receptor agonist -- because of the death of a 14-year-old patient in one of the studies.
Feb. 25, 2013 -- Fatal anaphylactic reactions that forced the recall of a recently approved anemia drug this week are an unavoidable risk with any new drug, allergists and other experts said.
Feb. 23, 2013 -- In a system where half of all clinical trials are never made public, doctors are merely "imagining that we're practicing evidence-based medicine," says Ben Goldacre, MBBS, one of the most vocal critics of drugmakers who refuse to hand over complete clinical trial data.
Feb. 20, 2013 -- Using different selection criteria for lung cancer screening may catch more disease than the currently recommended criteria, researchers found.
Feb. 16, 2013 -- When Hurricane Sandy shut down a number of its hospitals, New York University researchers worked overtime to keep clinical trials going, but enrollment in new trials is down, according to investigators.
Feb. 11, 2013 -- HONOLULU -- Wouldn't it be nice if a clinical trial took only months to initiate rather than years? The NIH thinks so too and has a plan to make that dream come true, deputy director Walter Koroshetz, MD, said in this exclusive InFocus interview.
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Fundamentals of Clinical Trials see details » « hide
Clinical Trial see details » « hide
Conducting Clinical Research: A Practical Guide for Physicians, Nurses, Study Coordinators, and Investigators see details » « hide
Explains how to land a study on good terms
Provides tips for recruiting patient volunteers--and keeping them happy
Offers easy strategies for coordinating studies
Demystifies regulatory requirements
With a comprehensive index and appendices, this book has been adopted by university health sciences programs across the country.
The first edition was a Ben Franklin Awards 2007 Finalist and a 2007 Finalist in ForeWord Magazine's reference category for professional/technical books.
New, expanded, and completely updated sections keep readers abreast of changes in the rapidly shifting global drug development industry, including new regulations affecting research, subject injury clauses, the unique needs of device and vaccine trials, the impact of HIPAA on U.S. research, cultural competency and health literacy, ethical considerations in clinical research, and how to survive audits.
Clinical Trials: A Methodologic Perspective Second Edition(Wiley Series in Probability and Statistics) see details » « hide
This Second Edition of the critically hailed Clinical Trials builds on the text's reputation as a straightforward and authoritative presentation of statistical methods for clinical trials. Readers are introduced to the fundamentals of design for various types of clinical trials and then skillfully guided through the complete process of planning the experiment, assembling a study cohort, assessing data, and reporting results. Throughout the process, the author alerts readers to problems that may arise during the course of the trial and provides commonsense solutions.
The author bases the revisions and updates on his own classroom experience, as well as feedback from students, instructors, and medical and statistical professionals involved in clinical trials. The Second Edition greatly expands its coverage, ranging from statistical principles to controversial topics, including alternative medicine and ethics. At the same time, it offers more pragmatic advice for issues such as selecting outcomes, sample size, analysis, reporting, and handling allegations of misconduct. Readers familiar with the First Edition will discover completely new chapters, including:
* Contexts for clinical trials
* Statistical perspectives
* Translational clinical trials
* Dose-finding and dose-ranging designs
Each chapter is accompanied by a summary to reinforce the key points. Revised discussion questions stimulate critical thinking and help readers understand how they can apply their newfound knowledge, and updated references are provided to direct readers to the most recent literature.
This text distinguishes itself with its accessible and broad coverage of statistical design methods--the crucial building blocks of clinical trials and medical research. Readers learn to conduct clinical trials that produce valid qualitative results backed by rigorous statistical methods.
Clinical Trials - A Practical Guide to Design, Analysis, and Reporting see details » « hide
Clinical Trials: Study Design, Endpoints and Biomarkers, Drug Safety, and FDA and ICH Guidelines see details » « hide
Clinical Trials: Study Design, Endpoints and Biomarkers, Drug Safety, and FDA and ICH Guidelines is a practical guidebook for those engaged in clinical trial design. This book details the organizations and content of clinical trials, including trial design, safety, endpoints, subgroups, HRQoL, consent forms and package inserts. It provides extensive information on both US and international regulatory guidelines and features concrete examples of study design from the medical literature. This book is intended to orient those new to clinical trial design and provide them with a better understanding of how to conduct clinical trials. It will also act as a guide for the more experienced by detailing endpoint selection and illustrating how to avoid unnecessary pitfalls. This book is a straightforward and valuable reference for all those involved in clinical trial design.
- Provides extensive coverage of the "study schema" and related features of study design
- Offers a "hands-on" reference that contains an overview of the process, but more importantly details a step-by-step account of clinical trial design
- Features examples from the medical literature to highlight how investigators choose the most suitable endpoint(s) for clinical trial and includes graphs from real clinical trials to help explain each concept in study design
- Integrates clinical trial design, pharmacology, biochemistry, cell biology and legal aspects to provide readers with a comprehensive look at all aspects of clinical trials
Designing Clinical Research see details » « hide
Designing Clinical Research sets the standard for providing a practical guide to planning, tabulating, formulating, and implementing clinical research, with an easy-to-read, uncomplicated presentation. This edition incorporates current research methodology—including molecular and genetic clinical research—and offers an updated syllabus for conducting a clinical research workshop.
Emphasis is on common sense as the main ingredient of good science. The book explains how to choose well-focused research questions and details the steps through all the elements of study design, data collection, quality assurance, and basic grant-writing. All chapters have been thoroughly revised, updated, and made more user-friendly.
A Clinical Trials Manual From The Duke Clinical Research Institute: Lessons from a Horse Named Jim see details » « hide
—Robert Harrington, Professor of Medicine, Director, Duke Clinical Research Institute, Durham, North Carolina, USA
The Duke Clinical Research Institute (DCRI) is one of the world's leading academic clinical research organizations; its mission is to develop and share knowledge that improves the care of patients around the world through innovative clinical research. This concise handbook provides a practical "nuts and bolts" approach to the process of conducting clinical trials, identifying methods and techniques that can be replicated at other institutions and medical practices.
Designed for investigators, research coordinators, CRO personnel, students, and others who have a desire to learn about clinical trials, this manual begins with an overview of the historical framework of clinical research, and leads the reader through a discussion of safety concerns and resulting regulations. Topics include Good Clinical Practice, informed consent, management of subject safety and data, as well as monitoring and reporting adverse events.
Updated to reflect recent regulatory and clinical developments, the manual reviews the conduct of clinical trials research in an increasingly global context. This new edition has been further expanded to include:
- In-depth information on conducting clinical trials of medical devices and biologics
- The role and responsibilities of Institutional Review Boards, and
- Recent developments regarding subject privacy concerns and regulations.
Ethical documents such as the Belmont Report and the Declaration of Helsinki are reviewed in relation to all aspects of clinical research, with a discussion of how researchers should apply the principles outlined in these important documents. This graphically appealing and eminently readable manual also provides sample forms and worksheets to facilitate data management and regulatory record retention; these can be modified and adapted for use at investigative sites.
A Concise Guide to Clinical Trials see details » « hide
A Concise Guide to Clinical Trials provides a comprehensive yet easy-to-read overview of the design, conduct and analysis of trials. It requires no prior knowledge on the subject as the important concepts are introduced throughout. There are chapters that distinguish between the different types of trials, and an introduction to systematic reviews, health-related quality of life and health economic evaluation. The book also covers the ethical and legal requirements in setting up a clinical trial due to an increase in governance responsibilities and regulations.
This practical guidebook is ideal for busy clinicians and other health professionals who do not have enough time to attend courses or search through extensive textbooks. It will help anyone involved in undertaking clinical research, or those reading about trials. The book is aimed at:
- Those wishing to learn about clinical trials for the first time, or as a quick reference guide, for example as part of a taught course on clinical trials
- Health professionals who wish to conduct their own trials, or participate in other people’s studies
- People who work in pharmaceutical companies, grant funding organisations, or regulatory agencies