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Trials and tribulations: the ISIS experience.
1University of Oxford, John Radcliffe Hospital, Headington, UK.
Australian and New Zealand Journal of Medicine
|October 1, 1992
Summary
The ISIS trials group pioneered large-scale clinical trials, demonstrating that simple, large trials effectively assess treatments for common conditions. This approach significantly advanced medical research and patient care.
Area of Science:
- Cardiology
- Clinical Trials Methodology
- Evidence-Based Medicine
Background:
- The ISIS trials group evolved over a decade to include approximately 1000 hospitals globally.
- Initial work focused on quantitative infarct size measurement, leading to a preliminary trial of intravenous atenolol.
Purpose of the Study:
- To address the inadequacy of small clinical trials in reliably evaluating moderate but medically significant treatments.
- To establish a large-scale collaborative trial network for efficient and effective medical research.
Main Methods:
- Development of a large international collaboration of hospitals for conducting trials.
- Focus on simple trial designs to facilitate rapid patient entry and data collection.
- Trials are funded primarily by industry with oversight from an international steering committee and data monitoring committees.
Main Results:
- The collaborative approach enabled the reliable assessment of treatments for common medical conditions.
- Large, simple trials proved effective in answering critical clinical questions rapidly.
- Overview of three completed trials will be presented, offering insights into their execution.
Conclusions:
- Large-scale, simple clinical trials are a powerful tool for advancing medical knowledge.
- The ISIS trials methodology has significantly contributed to evidence-based medicine.
- The collaborative model fosters efficient and effective clinical research worldwide.