title: 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.
authors.forename: Ellis W
authors.initials: EW
authors.lastname: Lader
authors.forename: Christopher P
authors.initials: CP
authors.lastname: Cannon
authors.forename: E Magnus
authors.initials: EM
authors.lastname: Ohman
authors.forename: L Kristin
authors.initials: LK
authors.lastname: Newby
authors.forename: Daniel P
authors.initials: DP
authors.lastname: Sulmasy
authors.forename: Robyn J
authors.initials: RJ
authors.lastname: Barst
authors.forename: Joan M
authors.initials: JM
authors.lastname: Fair
authors.forename: Marcus
authors.initials: M
authors.lastname: Flather
authors.forename: Jane E
authors.initials: JE
authors.lastname: Freedman
authors.forename: Robert L
authors.initials: RL
authors.lastname: Frye
authors.forename: Mary M
authors.initials: MM
authors.lastname: Hand
authors.forename: Robert L
authors.initials: RL
authors.lastname: Jesse
authors.forename: Frans
authors.initials: F
authors.lastname: Van de Werf
authors.forename: Fernando
authors.initials: F
authors.lastname: Costa
mesh_terms: D002755:Choice Behavior; D015510:Clinical Medicine / Q000331:legislation & jurisprudence / Q000458:organization & administration; D002986:Clinical Trials as Topic / Q000191:economics / Q000331:legislation & jurisprudence; D019317:Evidence-Based Medicine; D006801:Humans; D010819:Physician's Role; D011331:Private Practice; D016032:Randomized Controlled Trials as Topic; D012108:Research Personnel / Q000331:legislation & jurisprudence / Q000706:statistics & numerical data / Q000600:supply & distribution; D000078329:Workforce