Books We're Reading

White Coat, Black Hat: Adventures on the Dark Side of Medicine

Elliot, C. White Coat, Black Hat: Adventures on the Dark Side of Medicine. Boston, Beacon; September 2010. [Amazon.com]: http://preview.tinyurl.com/25l9mml

Reviews:
More Tidbits from White Coat, Black Hat. Howard Brody, M.D. 2010-08-22: http://brodyhooked.blogspot.com/2010/08/more-tidbits-from-white-coat-black-hat.html
A Guided Tour of Modern Medicine's Underbelly. Abigail Zuger, M.D. The New York Times. 2010-09-27: http://www.nytimes.com/2010/09/28/health/28zuger.html

About Carl Elliot, M.D., Ph.D. (University of Minnesota Center for Bioethics) Accessed on 2010-10-11 at: http://www.ahc.umn.edu/bioethics/facstaff/elliott_c/home.html

Clinical Trials: What Patients and Healthy Volunteers Need to Know

New Book — for Patients and Healthy Volunteers
If you are already in a clinical trial, or considering entering a clinical trial, this book is a must read.

Education about the process is an important aspect of empowerment. This book provides you with many useful questions to ask yourself, the investigator, your doctor and others involved with the process of clinical trials.

About the Author, Lorna Speid, Ph.D.
Dr. Speid is a qualified UK Pharmacist, working in San Diego, California, USA. She has a lot of experience designing clinical trials and developing drugs for unmet medical needs. She is very aware of the need to ensure patients and healthy volunteers are an empowered part of the process.

Summary
The book Clinical trials: What Patients and Healthy Volunteers Need to Know is now available from major bookstores and on the internet at Amazon.com and other major sites. Clinical investigators involved with clinical trials in major investigative institutions in the United States have advised that they will provide the book to research subjects if it is made available to them by pharmaceutical companies for this purpose. We are exploring this possibility for bulk sales, but wish to ensure that as many patients and healthy volunteers as possible are aware that they can buy the book in books stores now.

Why is the Book Important
Every year thousands of people, many of them with serious illnesses, take part in clinical trials. The clinical trial process is complex even for those of us who are involved in the business of designing, setting up, monitoring or regulating clinical trials. The process is a maze for research subjects and potential research subjects. Patients and healthy volunteers interested in taking part in clinical trials will find that at least 29,000,000 hits will come up on Google for the term clinical trials. Even if this amount of information could be sorted, the information would be difficult to sift through. Currently, less than 5% of adult cancer patients are currently enrolled in clinical trials. The reasons for this are various, but will include a dearth of easily digestible information on the process of enrolling in clinical trials. Information provided by pharmaceutical companies for specific clinical trials is limited to the trial in question. This information does not educate the patient about the clinical trial process in general. This lack of understanding of what is effected from them leads to research subjects that are not fully engaged in the process. Compliance is not as optimal as it could be and the results of clinical trials are impacted, as a result.

This book Clinical trials: What Patients and Healthy Volunteers Need to Know explains the process of clinical trials in the drug development context. Potential and research subjects as well as parents and guardians are provided information that will equip them to be a part of the decision making process involved with taking part in clinical trials. The research subject should be able to ask intelligent questions before signing the informed consent document. If a parent or guardian is going to sign the form on behalf of a child, the parent/guardian will be in a better position to do so.

Speid, L. Clinical Trials: What Patients and Healthy Volunteers Need to Know. New York, Oxford University Press; 2010.

Oxford University Press: http://www.oup.com/us/catalog/general/subject/Medicine/?view=usa&ci=9780199734160

Amazon.com: http://preview.tinyurl.com/24k9qx9

The Professional Guinea Pig: Big Pharma and the Risky World of Human Subjects

Review: Inside the Risky World of Drug-Trial 'Guinea Pigs'. David Glenn. The Chronicle of Higher Education. 2010-07-11: http://chronicle.com/article/Inside-the-Risky-World-of/66225/

Abadie, RL. The Professional Guinea Pig: Big Pharma and the Risky World of Human Subjects. Durham, Duke University Press; 2010. [Amazon.com]: http://tinyurl.com/277hycs

What the Doctor Didn't Say: The Hidden Truth About Medical Research

Menikoff, J., Richards, EP. What the Doctor Didn't Say: The Hidden Truth About Medical Research. New York, Oxford University Press; 2006. [Amazon.com]: http://preview.tinyurl.com/26wobed

Review: Woodward BA. New Engl J Med. 2007; 356:877-878: http://www.nejm.org/doi/full/10.1056/NEJMbkrev57458

Smart Mice, Not-So-Smart People: An Interesting and Amusing Guide to Bioethics

Review: Norman N. Goldfarb. Journal of Clinical Research Best Practices. 2010;6(8): http://www.firstclinical.com/journal/2010/1008_Smart.pdf

Caplan, AL. Smart Mice, Not-So-Smart People: An Interesting and Amusing Guide to Bioethics. Rowman & Littlefield; 2007. [Amazon.com]: http://preview.tinyurl.com/25lrugy

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