The clinician as investigator: participating in clinical trials in the practice setting.

Abstract:

:The rapid development of new drugs, therapies, and devices has created a dramatic increase in the number of trials needed to properly evaluate them. The majority of patients treated today, many of whom could be eligible for participation in these studies, are seen in community hospitals and medical practices that are not affiliated with an academic medical center. Thus, there is a demonstrable need for physicians in private practice to enlist as investigators in these trials. This article is intended to encourage those physicians by describing the need and providing the rationale for their participation. It covers basic requirements for participating in clinical trials and outlines ethical, regulatory, financial, and other logistical issues of importance for the potential investigator and provides an algorithm for selecting a study for participation. Finally, the appendices review basic elements of study design and statistical principles, which may be of interest to a potential investigator.

journal_name

Circulation

journal_title

Circulation

authors

Lader EW,Cannon CP,Ohman EM,Newby LK,Sulmasy DP,Barst RJ,Fair JM,Flather M,Freedman JE,Frye RL,Hand MM,Jesse RL,Van de Werf F,Costa F,American College of Cardiology Foundation.

doi

10.1161/01.CIR.0000128702.16441.75

subject

Has Abstract

pub_date

2004-06-01 00:00:00

pages

2672-9

issue

21

eissn

0009-7322

issn

1524-4539

pii

109/21/2672

journal_volume

109

pub_type

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