http://www.loc.gov/mods/v3 http://www.loc.gov/standards/mods/v3/mods-3-2.xsd
Why Clinical Research Can't Guarantee the Right Medical Answers
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 Women’s Risk of Heart Disease (San Francisco Chronicle, 1994) Hormones Don’t 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.
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 – They'ever 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 – What's 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 -- Journey's End – A Call for Action.
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