Tuesday, June 15, 2010

Birthing a New...Book!

Longer than the usual gestation, the 2nd edition of Conducting Clinical Research just came into being. A bit overdue, the past 10 months have been an immersion of reading, research, and writing to bring you an expanded, revised, and fully updated edition.

CCR 2nd shares the basic genetic makeup of its older sibling—a pragmatic, step-by-step, how-to manual for both experienced medical professionals and newbies, and shares the dominant wry humor gene.

There are notable differences, with many updates including recent regulations affecting research, subject injury clauses, tips on surviving audits and legal landmines. New topics include the unique needs of device and vaccine trials, perspective on the globalization and outsourcing of clinical trials, cultural competency and health literacy—keys to understanding and succeeding with the changing dynamics of the industry.

My first-born was greeted with much critical acclaim:

"Successfully covers . . . clinical trials. Practical considerations, substantial background and resource information. The text is well written . . . fills an important need."

—Annals of Internal Medicine, April 2007

“5 Stars! (100 out of 100)… This is a must have for novice or experienced clinical researchers.”

Doody's Review: Expert Review 2007

Sibling rivalry portends even greater success for the new addition.

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To find out more, click here for an excerpt, table of contents, and complete description.

Please share our joy with your friends.


Monday, June 14, 2010

The Rise of the Superbugs

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This week has brought news of new superbugs--daptomycin-resistant VRE (Vancomycin-resistant Enterococcus) isolates and linezolid-resistant MRSA.

I've cared for patients this week with MRSA, VRE, and ESBL gram-negative rods resistant to almost every antibiotic.

Many factors fuel the rise in resistant organisms. Some that are not often addressed include inadequate education (e.g. that asymptomatic Foley catheter related cultures should not be treated);

fear of peer review or legal liability for not treating a culture;

the demands of family or religious groups that “everything be done” even when the patient is clearly terminal and the treatment is futile—and where the treatment of one such patient puts many others at unnecessary risk.

A excellent overview of some of the other issues can be found at the Center for Global Development’s drug resistance site.

As an Infectious Disease physician who has been involved in clinical research for new antibiotics as well as patient care, I am very familiar with the difficulties of bringing a new drug to market. In fact, I participated in early clinical trials for both Daptomycin and Linezolid. It angers and saddens me to see these valuable and critical resources squandered by irresponsible detailing and prescribing patterns and because of liability concerns. We need serious guidelines and restrictions on antibiotic use if we are not to soon enter the post-antibiotic era. There is no time to wait for new drugs to be developed.