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It's Great! Oops, No It Isn't


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Oktober 2008

Beschreibung

Beschreibung

This book dissects medical research methodology and through a penetrating inquiry into its triumphs and tragedies 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 they've ended up with a truthful answer. In It's Great! readers learn 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, and 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, it's their health that is at stake. TOC:Preface
Part One: Medical Research Explained
Chapter 1. Medical Research - Searching For AnswersChapter 2. The Case-Control Method - Looking Backward Chapter 3. The Cohort Study - Watchful Waiting Chapter 4. The Clinical Trial - The Gold Standard Chapter 5. Comparing The Methods - Qualitative Differences
Part Two: Understanding The Clinical Trial
Chapter 6. The Protocol - The Guiding Light Chapter 7. The Control Group - Leveling The Playing Field Chapter 8. Measurements - They're Never Exact Chapter 9. Bias Control - A Closer Look At Blinding And Randomization Chapter 10. Utility -Are Clinical Trial Results Useful? Chapter 11. Research Discrimination - Inadequately Tested Populations Chapter 12. Seven Deadly Flaws - The Achilles' Heel Of The Clinical Trial
Part Three: Tools Of The Trade
Chapter 13. Statistics - Was The Finding Significant? Chapter 14. Analysis Issues - A Lot Of Choices Chapter 15. The Meta Analysis - An Alternative To Large Trials
Part Four: The Real World
Chapter 16. Research Results that Clashed - What's The Right Answer? Chapter 17. Hormone Replacement Therapy - The Silver Bullet That Misfired Chapter 18. Publishing - Getting The Word Out To Doctors Chapter 19. Communicating - Sharing The News With The Public Chapter 20. Product Development - Getting Discoveries To The Market Chapter 21. Medical Innovation - Regulators, Resources And Results Chapter 22. Science And Politics - A Troubling Mixture Chapter 23. Research Misconduct - Irresistible Temptation Chapter 24. Postmarketing Surveillance - An Imperfect System Chapter 25. Regulatory Reform - Changes Needed Chapter 26. Journey's End - A Call For Action
Notes/BibliographyGlossaryIndex

Inhaltsverzeichnis

Preface Part One: Medical Research Explained Chapter 1. Medical Research - Searching For Answers
Chapter 2. The Case-Control Method - Looking Backward
Chapter 3. The Cohort Study - Watchful Waiting
Chapter 4. The Clinical Trial - The Gold Standard
Chapter 5. Comparing The Methods - Qualitative Differences Part Two: Understanding The Clinical Trial Chapter 6. The Protocol - The Guiding Light
Chapter 7. The Control Group - Leveling The Playing Field
Chapter 8. Measurements - They're Never Exact
Chapter 9. Bias Control - A Closer Look At Blinding And Randomization
Chapter 10. Utility -Are Clinical Trial Results Useful?
Chapter 11. Research Discrimination - Inadequately Tested Populations
Chapter 12. Seven Deadly Flaws - The Achilles' Heel Of The Clinical Trial Part Three: Tools Of The Trade Chapter 13. Statistics - Was The Finding Significant?
Chapter 14. Analysis Issues - A Lot Of Choices
Chapter 15. The Meta Analysis - An Alternative To Large Trials Part Four: The Real World Chapter 16. Research Results that Clashed - What's The Right Answer?
Chapter 17. Hormone Replacement Therapy - The Silver Bullet That Misfired
Chapter 18. Publishing - Getting The Word Out To Doctors
Chapter 19. Communicating - Sharing The News With The Public
Chapter 20. Product Development - Getting Discoveries To The Market
Chapter 21. Medical Innovation - Regulators, Resources And Results
Chapter 22. Science And Politics - A Troubling Mixture
Chapter 23. Research Misconduct - Irresistible Temptation
Chapter 24. Postmarketing Surveillance - An Imperfect System
Chapter 25. Regulatory Reform - Changes Needed
Chapter 26. Journey's End - A Call For Action Notes/Bibliography
Glossary
Index

Innenansichten

Leseprobe

"Defining the Experimental Treatment (p.49-50)

Researchers clearly know what experimental agent they intend to study, but they must also specify how and when it is to be used. Again, as obvious as it might seem, that decision may not be so easy for new experimental compounds. From medieval days it was known that often what distinguished a medicine from a poison was the dosage. The number of exposures, the actual dose in each exposure, the timing of the doses, and the length of exposure all matter. Even the most benign substance can be toxic when administered in a high enough dose. Look at radiation, in low doses it kills cancer cells, in high doses it kills the patient.

The research leading up to large-scale clinical trials tends to rely on studies with only a small number of patients. The emphasis in early drug research is on establishing the safety of the drug rather than its efficacy. Small safety studies make sense since it is unwise to subject a lot of people to a newly developed drug. An efficacious dose is looked for by performing more small studies until researchers decide that theres sufficient information to allow the new therapy to enter a more vigorous efficacy-testing phase. The planned dosage schedule for these large-scale trials come from the small clinical trials as well as work done in animals. Consequently, there can be a scarcity of information on humans and the wrong clinical dose may be selected and used in the protocols for the rest of the research program.

Another factor that raises the risk of using an inappropriate dose occurs when there is a lot of pressure to quickly find a ""cure"" for a grave disease. In that circumstance it is understandable that people want access to a new therapy as early as possible. This pressure may result in selecting a suboptimal dose prematurely. Failure to list the best possible dose in the protocols of investigative studies is well illustrated by the
antidepressant drug imipramine. Imipramine was a very successful drug, a market leader, and as a result frequently chosen as the control treatment for new antidepressant drug studies done in the 1960s. However, it turned out that the treatment schedules were often too short and the dose too low. A report in the American Journal of Psychiatry found that imipramine dose in those trials was often half of what doctors now consider the optimal dose.

Furthermore, the studies often lasted less than four weeks, and it is now recognized that trials must be longer than four weeks to get the most favorable drug effect. The experimental drug can also be a marketed drug that may have new uses. An example of this is the doctor trials conducted in the U.K. and the U.S. at about the same time. The trials had the same goal, each wanted to see if aspirin could prevent a heart attack. Despite the same goal and the use of male physicians as subjects, plus the fact there was collaboration between the trial designers, their protocols differed markedly in terms of the aspirin dosages. The British physicians received three times the dose of aspirin compared to that used in the American study."

Pressestimmen

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


It's Great! Oops, No It Isn't


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 women's risk of heart disease" but by 2001 that optimistic report was reversed as evidenced by a Washington Post article titled, "Hormones don't protect women from heart disease."

People are confused because they do not understand the process behind these conflicting results. A new book can help - It's Great! Oops, No It Isn't: Why Clinical Research Can't 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 h


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EAN: 9781402089077
Untertitel: Why Clinical Research Can't Guarantee The Right Medical Answers. 2009. Auflage. Sprache: Englisch. Dateigröße in MByte: 3.
Verlag: Springer Netherlands
Erscheinungsdatum: Oktober 2008
Format: pdf eBook
Kopierschutz: Adobe DRM
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