As such, I began the ASHP Intensive Study B: Evaluating Clinical Trials in Hypertension and Dyslipidemia: Applying Recent Guideline Changes to Patient Care with the hopes of learning a little more about the management of these issues
From a investigational drug standpoint, the NIH has stopped accepting new patients in clinical trials at the moment, but are currently keeping with their currently enrolled patients
In some cases, safety issues seen in animals lead to the unnecessary abandonment of promising drugs and in other cases, safety signals that appear in humans during clinical trials may not have been detected in animals
Seeding is a term defined as "Clinical trials, deceptively portrayed as patient studies which are used to promote drugs recently approved or under review by the FDA by encouraging prescribers to use these medication under the guise of participating as an investigator in a clinical trial". What the drug companies (in this case Parke-Davis, a subsidiary of Pfizer Inc who as a matter of fact payed 2.3 billion in "misbranding" Bextra) do is essentially reach out to most primary care physicians the majority of which have little experience as investigators in clinical trials, and ask them to be a part of a study. Each physician is assigned a small number of patients (less than 10), which is unusual for clinical trials due to the sheer increase in logistical problems this creates such as ensuring physicians follow proper protocol
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Intensive Studies Module A provides translation of pharmacogenomics to practice, while Intensive Studies Module B focuses on evaluating clinical trials in hypertension and dyslipidemia
Similar to all my other rotations, I have learned an incredible amount about the practice of pharmacy; there is endless information for me to absorb about oncologic pharmacotherapy, pharmacokinetics, drug interactions, clinical trials and – of course – the ubiquitous side effects of chemotherapy
Effect of citalopram on agitation in Alzheimer disease: the CitAD randomized clinical trial. JAMA. 2014; 311:682-91