What the Doctor Didn't Say: The Hidden Truth about Medical Researchby Jerry Menikoff, Edward P. Richards
Pub. Date: 08/07/2006
Publisher: Oxford University Press, USA
Millions of people each year decide to participate in clinical trialsmedical research studies involving an innovative treatment for a medical problem. For the patient, such participation can sometimes be a life-saving choice. But it can also be just the opposite. Our country years ago adopted rules designed to assure that people are making informed choices
Millions of people each year decide to participate in clinical trialsmedical research studies involving an innovative treatment for a medical problem. For the patient, such participation can sometimes be a life-saving choice. But it can also be just the opposite. Our country years ago adopted rules designed to assure that people are making informed choices about participation. This book explains the reality behind those rules: that our current system of clinical trials hides much of the information patients need to make the right choices.
Witness the following scenarios:
-Hundreds of patients with colon cancer undergo a new form of keyhole surgery at leading cancer centersnever being told that 85% of colorectal surgeons, worried that it increases the risk of the cancer returning, would not themselves undergo that procedure.
-Tens of thousands of women at high risk of developing breast cancer are asked to participate in a major research study. They are told about the option of having both breasts surgically removedbut not told about the option of taking a standard osteoporosis pill that might cut the risk of getting breast cancer by one-half or more.
What The Doctor Didn't Say, principally written by a nationally prominent expert, is the first book to reveal many heretofore hidden aspects about the true nature of participation in clinical trials. It shows why options not commonly knownincluding getting a new treatment outside of a research studycan often be the best choice. It explains how patients can make good decisions even if there is only limited information about a treatment's effect. And it does this through the eye-opening stories of what is happening daily to thousands of people.
This book ends up confronting the fundamental dilemma of medical research: Participation in clinical trials plays a vital role in advancing knowledge, and many experts fear that if the information provided herein became widely known, fewer people would participate. But the authors demonstrate that there is no need to deceive people into participating in research. We can have a system that promotes participation while still providing truthful information to participants.
- Oxford University Press, USA
- Publication date:
- Edition description:
- Product dimensions:
- 9.30(w) x 6.30(h) x 0.80(d)
Table of Contents
1. The Dilemma of Human Research
Part I: How Good Studies Can Be Bad Choices
2. The Nature of Research
3. A Case Study: The Difference Between Being a Patient and Being a Research Subject
4. How the Law Protects Patients Who Get Non-Standard Care
5. The Weakened Legal Protections Given to Research Subjects
6. How Bad for the Subjects Can the Study Be?
Part II: Consent: What Are Subjects Told?
7. What Informed Consent Requires
8. The Anatomy of a Consent Form
9. The Good, the Bad, and the Ugly Research Study: From Consent to Choice
10. The Hidden Alternative
Part III: When Consent Can't Be Obtained
11. Incompetent Adults
12. Emergency Research
13. Children in Research: The Basic Rules
14. Can Children Be Enrolled in Studies That Are Bad for Them?
15. Research and Reproduction
Part IV: The Role of Money
16. Should Research Subjects be Paid?
17. Compensating Researchers: Dealing with Conflicts of Interest
Part V: The Challenge for the Future
18. Where Do We Go From Here: The Paradox of Pediatric Oncology Research
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