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CLRA 6220 Health Economics and Financial Management in Clinical Research Administration: Welcome & Course Readings

Welcome to your course guide

Please find your required library readings below. If you have problems with the links below, please contact the Library. If you have APA questions about these materials, please contact the Writing Center.

CLRA 6220 Required Course Readings

The links are for required readings found in the Walden databases ONLY. For all other readings, see your course resources.

Enter your myWalden user name and password at the prompt.

Abkowitz, A. (2009). Pfizer’s home remedy. Fortune, 160(4), 82–86.

Annemans, L., Geneste, B., & Jolain, B. (2000). Early modelling for assessing health and economic outcomes of drug therapy. Value in Health, 3(6), 427–434.

Arnst, C. (2009, September 3). Feds hit Pfizer with a $2.3 billion fine. BusinessWeek Online.

Arnst, C. (2009). The drug mergers’ harsh side effects. BusinessWeek, (4124), 26.

Barrett, J., & Jay, P. (2005). Clinical research fraud: A victimless crime? Applied Clinical Trials, 14(2), 44–46.

Chatterjee, P. (2008). Clinical trials in India: Ethical concerns. Bulletin of the World Health Organization, 86(8), 581–582.

de Pouvourville, G., Ulmann, P., Nixon, J., Boulenger, S., Glanville, J., & Drummond, M. (2005). The diffusion of health economics knowledge in Europe: The EURONHEED (European Network of Health Economics Evaluation Database) project. PharmacoEconomics, 23(2), 113–120.

Getz, K. A. (2009). Are academia and NIH bastions of integrity? Applied Clinical Trials,18(7), 32–36.

Glancszpigel, D., & Rácaro, G. (2007). Create a successful project plan for global trials. Applied Clinical Trials, 16(11), 52–54.

Harris, G. (2009, September 22). Debate flaring over grants for research. The New York Times.

Harris, G. (2009, December 18). Advisers on vaccines often have conflicts, report says. The New York Times.

Henderson, L. (2009). CRO and AMC collaboration. Applied Clinical Trials, 18(2), 52–53.

Jankosky, J., Jiang, Y., & Farwell, T. (2007). Grant budgeting and negotiating in India and China. Applied Clinical Trials, 16(11), 56–62.

Johal, S. S., Oliver, P., & Williams, H. C. (2008). Better decision making for evaluating new medical device projects: A real options approach. Journal of Medical Marketing, 8(2), 101–112.

Johnson, I., & Whalen, J. (2009, November 4). Corporate news: Novartis mounts ambitious push into China—Pharmaceutical giant commits $1 billion, citing rapidly growing market driven by health-care reform. The Wall Street Journal.

Leonhardt, D. (2009, November 8). Dr. Brent James will make it better. The New York Times Magazine, 30–37, 44, 46–47.

Meier, B. (2009, October 16). Panel finds shortcomings in bone study. The New York Times.

Mittra, J. (2007). Life science innovation and the restructuring of the pharmaceutical industry: Merger, acquisition and strategic alliance behaviour of large firms. Technology Analysis & Strategic Management, 19(3), 279–301.

Moore, J. (2009, Jul 13). A study under fire: A highly regarded surgeon and Medtronic cunsultant is under investigation for an allegedly fraudulent medical study involving and orthopedic product made by the med-tech giant. Star Tribune, pp. D.1-n/a.

Moses, H., Braunwald, E., Martin, J. B., & Thier, S. O. (2002). Collaborating with industry—Choices for the academic medical center. The New England Journal of Medicine, 347(17), 1371–1375.

Newby, D., & Hill, S. (2003). Use of pharmacoeconomics in prescribing research. Part 2: Cost-minimization analysis—when are two therapies equal? Journal of Clinical Pharmacy & Therapeutics, 28(2), 145–150.

Phillips, K. A. (2006). The intersection of biotechnology and pharmacogenomics: Health policy implications. Health Affairs, 25(5), 1271–1280.

Pocha, J. S. (2006). Animal tester. Forbes Asia, 2(18), 24–26.

Pollack, A. (2009, November 11). 2 drug firms extend deal to develop antibodies. The New York Times.

Prendergast, M., Abramovits, W., Boguniewicz, M., Lebwohl, M., Tokar, M., & Tong, K. B. (2004). Look beyond financial conflicts of interest in evaluating industry-academia collaborations in burden-of-illness and outcomes research studies in dermatology. Journal of Investigative Dermatology, 123(3), 452–454.

Quintiles; Quintiles announces clinical research partnership with the University of Pretoria. (2009, September 21). Biotech Business Week, 1589.

Research institutions leaving money on table. (2009). Clinical Trials Administrator, 7(9), 102–104.

Robertson, J., Lang, D., & Hill, S. (2003). Use of pharmacoeconomics in prescribing research. Part 1: Costs—moving beyond the acquisition price for drugs. Journal of Clinical Pharmacy & Therapeutics, 28(1), 73–79.

Rockoff, J. D. (2009, November 10). Corporate news: Pfizer shuts six R&D sites after takeover. The Wall Street Journal.

Shaw, G. (2005). Tapping alternative sources: Funding beyond the NIH. Genomics & Proteomics, 5(8), 12–18.

Troy, T. (2009). The end of medical miracles? Commentary, 127(6), 46–50.

Wechsler, J. (2009). Health reform shapes drug development. Applied Clinical Trials, 18(8), 24–26.

Weinfurt, K. P., Hall, M. A., Dinan, M. A., DePuy, V., Friedman, J. Y., Allsbrook, J. S., et al. (2008). Effects of disclosing financial interests on attitudes toward clinical research. JGIM: Journal of General Internal Medicine, 23(6), 860–866.

Weintraub, A. (2009, October 12). J&J tries to buy itself a pipeline. BusinessWeek, (4150), 58–60.

Whalen, J. (2009, November 11). Novartis launching Prevacid ad blitz—Drug firm budgets $200 million to promote its nonprescription heartburn treatment. The Wall Street Journal.

Willenberg, K. M. (2004). Managing clinical trials—Frustration or bliss? Journal of Oncology Management, 13(6), 24–26.

Wilson, D. (2009, November 16). Drug companies increase prices in face of change. The New York Times.

Young, M. (Ed.). (2009). Standard operating procedures: Don’t wait until audit looms to develop SOPs. Clinical Trials Administrator, 7(7), 73–75.

Young, M. (Ed.). (2009). Wave of CT future: Comparative effectiveness research gets $1.1 billion in fed stimulus bucks. Clinical Trials Administrator, 7(9), 97–100.

Other Readings

Optional or supplemental readings may or may not be available in the library. Find further information about optional readings here.

If you have questions about your required course textbooks, please contact Customer Care at support@waldenu.edu