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Multicentre European trials: their design, execution and relevance
1Department of Cardiology, Erasmus University, Rotterdam, The Netherlands.
Independent, scientifically based clinical trials in cardiology are crucial for advancing patient care. Research organizations must prioritize credibility and pathophysiological validity over sheer size for reliable data.
Area of Science:
- Cardiology
- Clinical Trials
- Health Services Research
Background:
- Multicentre randomized clinical trials in Europe have significantly impacted cardiology practice.
- The upcoming Single Europe Act in 1992 will further emphasize the role of such research.
- Independent, scientifically based research organizations are vital for advancing coronary artery disease research.
Purpose of the Study:
- To outline the arguments for independent research organizations in cardiology.
- To discuss the science, data management, and cost-benefit of clinical trials.
- To critique the 'Big is beautiful' trend in clinical trials and emphasize credibility.
Main Methods:
- Review of multicentre randomized clinical trials conducted in Europe.
- Discussion of cost-benefit, data acquisition, and management in clinical trials.
- Critique of trial size and simplicity, advocating for credibility and pathophysiological validity.
Main Results:
- Arguments for independent research organizations in cardiology are presented.
- The role of the pharmaceutical industry in clinical trials is examined.
- The CABRI trial is used as an example to illustrate data applicability and validity.
Conclusions:
- Independent research organizations are essential for rigorous cardiology research.
- Credibility and sound pathophysiological hypotheses are more important than large trial size.
- The economic usefulness and validity of trial data are critical for clinical practice.
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