The clinician as investigator: participating in clinical trials in the practice setting.
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.
Lader
Ellis W
EW
Cannon
Christopher P
CP
Ohman
E Magnus
EM
Newby
L Kristin
LK
Sulmasy
Daniel P
DP
Barst
Robyn J
RJ
Fair
Joan M
JM
Flather
Marcus
M
Freedman
Jane E
JE
Frye
Robert L
RL
Hand
Mary M
MM
Jesse
Robert L
RL
Van de Werf
Frans
F
Costa
Fernando
F
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