Division of Cardiology

Clinical Trials Unit (Clinical Pharmacology)

The clinical pharmacology unit is an important clinical research and teaching site within the Division, with a long track record in the evaluation of new pharmacotherapies for treatment of hypertension, angina, and hyperlipidemias.

Several National Institute of Health (NIH) and/or industry-sponsored trials are ongoing at any given time and nearly 1,000 patients are enrolled in trials annually. Recent or current studies conducted by this unit include the Women’s Health Initiative, ACIP, SHEP, AFFIRM and the initial clinical experience with the angiotensin II receptor antagonist, losartan, and two trials in the administration of angiogenic growth factors.

The following is a summary of the major teaching goals for fellows who rotate through this unit:

  1. learning the fundamentals of clinical pharmacology, including pharmacokinetics, pharmacodynamics, and rational drug therapies for cardiovascular disease
  2. learning the fundamentals of clinical investigation, including hypothesis generation, protocol design, recruitment strategies, data collection, data management, data analysis, manuscript preparation, and scientific presentation
  3. developing skills in the longitudinal follow-up of patients with chronic ischemic heart disease, arrhythmia, hypertension, hyperlipidemia and obesity participating in a clinical investigation
  4. learning new analytic techniques including 24-hour ambulatory monitoring for hypertension and ischemia, and non-invasive monitoring of vascular compliance
  5. learning how to analyze critically the pharmacologic and clinical trials literature and prepare a scholarly review on cutting edge topics

Fellows are involved, in collaboration with the clinical pharmacology unit staff, in the execution of all aspects of the ongoing clinical research trials, including study design, patient recruitment, clinical evaluation and testing, data compilation and presentation, and manuscript preparation. All clinical research activities are directly overseen by the Director (or his designee) and there are regular data review sessions with the unit staff.

In addition, selected fellows are encouraged to participate in study planning/design sessions with investigators from other institutions and all fellows are expected to produce a scholarly manuscript during their rotation. In addition to clinical activities related to study execution, patients referred to the clinical pharmacology unit have chronic cardiac disease and require longitudinal follow-up at least during the period of study. The fellow has consultative responsibility for this care, which enhances the outpatient educational component of the overall training program in cardiology. Topics in clinical pharmacology are frequently presented as part of the didactic core and during in cardiology grand rounds.

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