Methodological issues in conducting a community-based clinical drug trial.
OBJECTIVE
This paper explores the advantages and disadvantages of implementing a clinical drug trial in a closed community.


METHODS
In the study we conducted a randomized, double-blind, placebo-controlled clinical trial to evaluate the effects of an antacid containing aluminum hydroxide on serum lipoproteins in hypercholesterolemic adults.


RESULTS
The results of the trial, which was conducted on two Israeli kibbutzim (rural cooperative communities), have been published previously.


CONCLUSIONS
The kibbutz presents a unique setting for the conduct of a clinical trial. There were opportunities to uphold inclusion and exclusion criteria carefully, to obtain informed consent, to enhance dietary and drug adherence, to ensure the quality of data collection, to maintain the interest of the participants in the study, and to monitor closely adverse effects and patient safety. This report describes the unique circumstances under which the trial was conducted and the role of the clinician as a clinical investigator and discusses their implications for the internal validity and generalizability of the trial.
Sperber
A D
AD
Division of Internal Medicine, Soroka Medical Center, Beer-Sheva, Israel.
Henkin
Y
Y
Shany
S
S
D000328:Adult; D000368:Aged; D000536:Aluminum Hydroxide / Q000627:therapeutic use*; D003154:Community Medicine; D004311:Double-Blind Method; D006801:Humans; D006937:Hypercholesterolemia / Q000188:drug therapy*; D007258:Informed Consent; D008875:Middle Aged; D010349:Patient Compliance; D016032:Randomized Controlled Trials as Topic / Q000379:methods*; D015203:Reproducibility of Results; D012107:Research Design
D000536:Aluminum Hydroxide