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Methodological issues in conducting a community-based clinical drug trial
A D Sperber1, Y Henkin, S Shany
1Division of Internal Medicine, Soroka Medical Center, Beer-Sheva, Israel.
Family Practice Research Journal
|December 1, 1993
Summary
Conducting clinical trials in closed communities like Israeli kibbutzim offers unique advantages for participant adherence and data quality. This setting facilitated careful monitoring and enhanced the internal validity of the study.
Area of Science:
- Clinical research methodology
- Public health studies
- Pharmacological trials
Background:
- Closed communities present unique logistical and ethical considerations for clinical research.
- Previous studies have not fully explored the potential of communal living settings for drug trials.
Purpose of the Study:
- To explore the advantages and disadvantages of conducting clinical drug trials within a closed community.
- To evaluate the feasibility and impact of a communal setting on trial execution and data integrity.
Main Methods:
- A randomized, double-blind, placebo-controlled clinical trial was conducted.
- The study involved hypercholesterolemic adults residing in two Israeli kibbutzim.
- The trial assessed the effects of aluminum hydroxide antacid on serum lipoproteins.
Main Results:
- The kibbutz setting facilitated strict adherence to inclusion/exclusion criteria.
- Enhanced participant engagement and adherence to study protocols were observed.
- High-quality data collection and close monitoring of adverse events were achieved.
Conclusions:
- The Israeli kibbutz model provides a unique and advantageous environment for clinical trials.
- This setting supports robust study conduct, improving internal validity and generalizability.
- The clinician's role as a clinical investigator is crucial for success in such unique research environments.