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The Clinical Pharmacist as Principal Investigator: A Commentary from the American College of Clinical Pharmacy
Author(s) -
Myryam Bayat,
Lisa E. Davis,
Daren L. Knoell,
Joan KorthBradley,
Mark A. Munger,
Mark S. Shaefer,
Peter H. Vlasses,
Daniel P. Wermeling,
Michael R. Ujhelyi
Publication year - 2000
Publication title -
pharmacotherapy: the journal of human pharmacology and drug therapy
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 1.227
H-Index - 109
eISSN - 1875-9114
pISSN - 0277-0008
DOI - 10.1592/phco.20.6.599.35165
Subject(s) - pharmacy , clinical pharmacy , principal (computer security) , citation , pharmacist , medicine , alternative medicine , family medicine , medical education , library science , computer science , pathology , operating system
Research is critical to advancing the practice of pharmacy. Indeed, the last three decades contain many examples where seminal research papers authored by clinical pharmacists have advanced pharmacy care and improved patient outcomes. Whereas many clinical pharmacists have established strong research programs, there must be continued efforts to increase the number of highly competent pharmacist researchers by reducing barriers into a research career and improving the quality of research training programs. The American College of Clinical Pharmacy (ACCP) continues to receive inquiries regarding the requisites for a pharmacist to serve as the principal investigator (PI) for industrysponsored research. This paper summarizes Food and Drug Administration (FDA) policies regarding the pharmacist’s ability to serve as PI on clinical drug research; presents a brief view on this issue from the perspective of the pharmaceutical industry; describes FDA regulations governing clinical research, and the PI’s responsibilities in meeting those regulations; and provides advice to clinical pharmacists who desire to serve as PIs on clinical drug research sponsored by the pharmaceutical industry.