Clinical pharmacology and therapeutics
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Clin. Pharmacol. Ther. · Sep 2009
Practice guidelines: development, application to clinical care, and role in provider education.
Substantial progress has been made in the past several decades toward the application of evidence-based medicine. Practice guidelines, which assist providers in clinical decision making, have played a valuable role in this initiative. This article highlights the attributes of good practice guidelines, along with their role in the education of health-care providers, and examines the development, revision, and limitations of practice guidelines for emerging infections.
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Clin. Pharmacol. Ther. · Jul 2009
Comparative StudyI-SPY 2: an adaptive breast cancer trial design in the setting of neoadjuvant chemotherapy.
I-SPY 2 (investigation of serial studies to predict your therapeutic response with imaging and molecular analysis 2) is a process targeting the rapid, focused clinical development of paired oncologic therapies and biomarkers. The framework is an adaptive phase II clinical trial design in the neoadjuvant setting for women with locally advanced breast cancer. I-SPY 2 is a collaborative effort among academic investigators, the National Cancer Institute, the US Food and Drug Administration, and the pharmaceutical and biotechnology industries under the auspices of the Foundation for the National Institutes of Health Biomarkers Consortium.
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"Counterfeit Drugs Kill" is the slogan the World Health Organization (WHO) uses in its anti-counterfeiting campaign. International organizations, governments of developed and developing countries, and the pharmaceutical industry created the IMPACT initiative (International Medical Products Anti-Counterfeiting Taskforce) to take on the thriving illegal industry that makes profits by selling fake drugs. However, before committing resources, policy makers want to assess the burden caused by counterfeit drugs in comparison with other health problems that compete for the limited resources available.