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Its Great! Oops, No It Isnt: Why Clinical Research Can't Guarantee The Right Med

Description: Its Great! Oops, No It Isnt by Ronald Gauch It uncovers the problems in medical investigations that can not be overcome no matter how much care and diligence medical researchers bring to a research project. FORMAT Hardcover LANGUAGE English CONDITION Brand New Publisher Description The truth is, few people know the first thing about clinical research. The public reads about a medical research project that announces unbelievable results for a miraculous drug. Some years later, another investigation completely wipes out those initial favorable findings. Hormones Cut Womens Risk of Heart Disease (San Francisco Chronicle, 1994) Hormones Dont Protect Women from Heart Disease, Study Says (Washington Post, 2001) The people are confused because we do not understand the process behind these conflicting results. Our health, and in fact, our very lives are dependent on clinical trials, but we know little about them. This book explains the issues the public needs to be aware of when it comes to clinical research. It uncovers the problems in medical investigations that can not be overcome no matter how much care and diligence medical researchers bring to a research project. The basic premise that drives the writing is that it is impossible for medical researchers to guarantee that they can get all the right answers from a single study. No matter how good the investigators are, no matter how well a study is planned, no matter how carefully the plans are executed and no matter how conscientiously the results are analyzed and interpreted – the answer may still be wrong. The deck is stacked against medical researchers and the public – you – should be skeptical of the results no matter how impressive they seem on the surface. Notes Tells consumers precisely why medical researchers cant promise that their investigations produced a correct finding by exposing sources of errors that go beyond the researchers controlExplains why the path drugs must travel as they make their way through the development phase and onto the market is flawedDescribes the pitfalls that occur when publishing and communicating medical research results to the medical profession and the publicOffers ways to improve the current systems of approving and monitoring drugsProvides the information patients, physicians and healthcare professionals need so their interests and concerns are heard by the medical research community Table of Contents Medical Research Explained.- Medical Research – Searching for Answers.- The Case-Control Method – Looking Backwards.- The Cohort Study – Watchful Waiting.- The Clinical Trial –The Gold Standard.- Comparing the Methods – Qualitative Differences.- Understanding the Clinical Trial.- The Protocol – The Guiding Light.- The Control Group – Leveling the Playing Field.- Measurements – Theyever Exact.- Bias Control – A Closer Look at Blinding and Randomization.- Utility – Are Clinical Trial Results Useful?.- Research Discrimination – Inadequately Tested Populations.- Seven Deadly Flaws – The Clinical Trials Achilles Heel.- Tools of the Trade.- Statistics – Was the Finding Significant?.- Analysis Issues – A Lot of Choices.- Meta Analysis – An Alternative to Large Trials.- The Real World.- Research Results That Clashed – Whats the Right Answer?.- Hormone Replacement Therapy – The Silver Bullet That Misfired.- Publishing – Getting the Word Out to Doctors.- The Public Forum – Sharing the News with the Public.- Product Development – Getting Discoveries to the Market.- Medical Innovations – Regulators, Resources and Results.- Science and Politics – A Troubling Mixture.- Research Misconduct – Irresistible Temptation.- Postmarketing Surveillance – An Imperfect System.- Regulatory Reform – Changes Needed.- Journeys End – A Call for Action. Review From the reviews: "Written by someone well versed in the complexities of biomedical research, this easy to understand book provides valuable information on the difficulty of finding the truth about drug safety and efficacy. (Dr.) Gauch has done us all a great service by explaining in a lucid and insightful manner why we need to be cautious in interpreting the results of preliminary, unconfirmed, or less than definitive clinical trials. This book is must reading not only for those involved in biomedical research, health care professionals, students and disease related society members but for the general public as well." (Stuart D. Cook, M.D. Past President, University of Medicine and Dentistry of New Jersey - currently the Ruth Dunietz Kushner and Michael Jay Serwitz Professor of Neurology and Neurosciences at the University) Press Release: Heidelberg, 8 October 2008 Its Great! Oops, No It Isnt New book explains why correct answers in medical research are so hard to achieve The truth is, few people know the first thing about clinical research. The public reads about a medical research project that announces unbelievable results for a miraculous drug. Some years later, another investigation completely wipes out those initial favorable findings. For example, a 1994 headline in the San Francisco Chronicle announced "Hormones cut womens risk of heart disease" but by 2001 that optimistic report was reversed as evidenced by a Washington Post article titled, "Hormones dont protect women from heart disease." People are confused because they do not understand the process behind these conflicting results. A new book can help - Its Great! Oops, No It Isnt: Why Clinical Research Cant Guarantee The Right Medical Answers by Ronald Gauch dissects medical research methodology. Through a penetrating inquiry into its triumphs and tragedies, it explains why correct answers are so hard to achieve. What emerges from this inquiry is the unexpected and stunning conclusion that medical researchers can never be sure that theyve ended up with a truthful answer. Gauch shows readers why the quest for knowledge through clinical trials is fraught with problems that even the best researchers cannot overcome. A fascinating gallery of cases illustrates the perils investigators face. Particular emphasis is given to the "clinical trial," the so-called gold standard for medical research. Its seven fatal flaws show succinctly why getting the right research answer is so problematic. In example after example, the author challenges the notion that medical research is too complex for the average citizen to comprehend. Understanding the imperfect world of clinical research allows the reader to step up and begin to ask his or her own questions, to challenge conclusions, to have doubts and not be afraid to raise them. People who care about their health and the health of others should not be innocent bystanders. They have a right, maybe even an obligation, to become involved. After all, its their health that is at stake. Ronald Gauch, Ph.D., spent most of his adult life involved in the application of research methods to clinical investigations. He has been a primary player in important medical studies of major pharmaceutical companies. He has also seen the research world from the academic side at Marist College. He is an excellent presenter, winner of a number of speaking competitions and awarded best teacher recognition on two occasions while at Marist College. As a consultant to the pharmaceutical and healthcare industries, and working with a number of local health-related organizations, he is involved with both the academic and practical world of medical research. The author is available for interview. Ronald R. Gauch Its Great! Oops, No It Isnt Why Clinical Research Cant Guarantee The Right Medical Answers 2008. XIV, 298 pages. Hardcover aC--39.95, $59.95, GBP31.99 ISBN 978-1-4020-8906-0 Contact: Joan Robinson tel +49-6221-4878130 (Germany) "Its Great!Oops, No It Isnt offers a behind-the-study look at how medical research is actually conducted, from the first protocol design to publication of the results. ... Gauchs book should be a must-read for anyone considering participating in a clinical trial." (Miller-McCune Turning Research into Solutions, March, 2009) Long Description The truth is, few people know the first thing about clinical research. The public reads about a medical research project that announces unbelievable results for a miraculous drug. Some years later, another investigation completely wipes out those initial favorable findings. Hormones Cut Womens Risk of Heart Disease (San Francisco Chronicle, 1994) Hormones Dont Protect Women from Heart Disease, Study Says (Washington Post, 2001) The people are confused because we do not understand the process behind these conflicting results. Our health, and in fact, our very lives are dependent on clinical trials, but we know little about them. This book explains the issues the public needs to be aware of when it comes to clinical research. It uncovers the problems in medical investigations that can not be overcome no matter how much care and diligence medical researchers bring to a research project. The basic premise that drives the writing is that it is impossible for medical researchers to guarantee that they can get all the right answers from a single study. No matter how good the investigators are, no matter how well a study is planned, no matter how carefully the plans are executed and no matter how conscientiously the results are analyzed and interpreted - the answer may still be wrong. The deck is stacked against medical researchers and the public - you - should be skeptical of the results no matter how impressive they seem on the surface. Review Quote From the reviews: "Written by someone well versed in the complexities of biomedical research, this easy to understand book provides valuable information on the difficulty of finding the truth about drug safety and efficacy. (Dr.) Gauch has done us all a great service by explaining in a lucid and insightful manner why we need to be cautious in interpreting the results of preliminary, unconfirmed, or less than definitive clinical trials. This book is must reading not only for those involved in biomedical research, health care professionals, students and disease related society members but for the general public as well." (Stuart D. Cook, M.D. Past President, University of Medicine and Dentistry of New Jersey - currently the Ruth Dunietz Kushner and Michael Jay Serwitz Professor of Neurology and Neurosciences at the University) Press Release: Heidelberg, 8 October 2008 Its Great! Oops, No It Isnt New book explains why correct answers in medical research are so hard to achieve The truth is, few people know the first thing about clinical research. The public reads about a medical research project that announces unbelievable results for a miraculous drug. Some years later, another investigation completely wipes out those initial favorable findings. For example, a 1994 headline in the San Francisco Chronicle announced "Hormones cut womens risk of heart disease" but by 2001 that optimistic report was reversed as evidenced by a Washington Post article titled, "Hormones dont protect women from heart disease." People are confused because they do not understand the process behind these conflicting results. A new book can help - Its Great! Oops, No It Isnt: Why Clinical Research Cant Guarantee The Right Medical Answers by Ronald Gauch dissects medical research methodology. Through a penetrating inquiry into its triumphs and tragedies, it explains why correct answers are so hard to achieve. What emerges from this inquiry is the unexpected and stunning conclusion that medical researchers can never be sure that theyve ended up with a truthful answer. Gauch shows readers why the quest for knowledge through clinical trials is fraught with problems that even the best researchers cannot overcome. A fascinating gallery of cases illustrates the perils investigators face. Particular emphasis is given to the "clinical trial," the so-called gold standard for medical research. Its seven fatal flaws show succinctly why getting the right research answer is so problematic. In example after example, the author challenges the notion that medical research is too complex for the average citizen to comprehend. Understanding the imperfect world of clinical research allows the reader to step up and begin to ask his or her own questions, to challenge conclusions, to have doubts and not be afraid to raise them. People who care about their health and the health of others should not be innocent bystanders. They have a right, maybe even an obligation, to become involved. After all, its their health that is at stake. Ronald Gauch, Ph.D., spent most of his adult life involved in the application of research methods to clinical investigations. He has been a primary player in important medical studies of major pharmaceutical companies. He has also seen the research world from the academic side at Marist College. He is an excellent presenter, winner of a number of speaking competitions and awarded best teacher recognition on two occasions while at Marist College. As a consultant to the pharmaceutical and healthcare industries, and working with a number of local health-related organizations, he is involved with both the academic and practical world of medical research. The author is available for interview. Ronald R. Gauch Its Great! Oops, No It Isnt Why Clinical Research Cant Guarantee The Right Medical Answers 2008. XIV, 298 pages. Hardcover e39.95, $59.95, Feature Tells consumers precisely why medical researchers cant promise that their investigations produced a correct finding by exposing sources of errors that go beyond the researchers control Explains why the path drugs must travel as they make their way through the development phase and onto the market is flawed Describes the pitfalls that occur when publishing and communicating medical research results to the medical profession and the public Offers ways to improve the current systems of approving and monitoring drugs Provides the information patients, physicians and healthcare professionals need so their interests and concerns are heard by the medical research community Details ISBN1402089066 Language English ISBN-10 1402089066 ISBN-13 9781402089060 Media Book Format Hardcover Year 2008 Imprint Springer-Verlag New York Inc. Place of Publication New York, NY Country of Publication United States Short Title IT S GRT OOPS NO IT ISN T 2009 Pages 298 Edition 2009th UK Release Date 2008-11-06 AU Release Date 2008-11-06 NZ Release Date 2008-11-06 US Release Date 2008-11-06 Illustrations XIII, 298 p. Author Ronald Gauch Publisher Springer-Verlag New York Inc. Edition Description 2009 ed. Publication Date 2008-11-06 Subtitle Why Clinical Research Cant Guarantee The Right Medical Answers. Alternative 9789048180233 DEWEY 610.72 Audience Professional & Vocational We've got this At The Nile, if you're looking for it, we've got it. With fast shipping, low prices, friendly service and well over a million items - you're bound to find what you want, at a price you'll love! TheNile_Item_ID:137616350;

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Its Great! Oops, No It Isnt: Why Clinical Research Can

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ISBN-13: 9781402089060

Book Title: Its Great! Oops, No It Isnt

Number of Pages: 298 Pages

Language: English

Publication Name: It's Great! Oops, No It Isn't: Why Clinical Research Can't Guarantee the Right Medical Answers.

Publisher: Springer-Verlag New York Inc.

Publication Year: 2008

Subject: Medicine, Mathematics, Healthcare System

Item Height: 235 mm

Item Weight: 1370 g

Type: Textbook

Author: Ronald Gauch

Item Width: 155 mm

Format: Hardcover

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