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The Lugano statements on controlled clinical trials
The Journal of International Medical Research
|January 1, 1987
Summary
Controlled clinical trials are essential for medical progress and patient benefit. Despite challenges, consensus indicates they are indispensable for advancing healthcare, outweighing potential trial disadvantages.
Area of Science:
- Clinical Trials
- Medical Research Ethics
- Evidence-Based Medicine
Background:
- Controlled clinical trials (CCTs) are crucial for medical advancement but face scrutiny regarding ethics and design.
- A consensus conference addressed 175 statements concerning CCTs, involving diverse stakeholders.
Purpose of the Study:
- To gauge expert opinion on critical issues surrounding the design, conduct, and regulation of CCTs.
- To determine the perceived necessity and ethical considerations of CCTs in modern medicine.
Main Methods:
- A consensus conference with 47 international representatives from academia, government, and industry.
- Validation of conference statements through a survey of 47 'matched pairs' non-attendees.
Main Results:
- Overwhelming consensus that CCTs are indispensable for medical progress.
- Participants and non-participants largely agreed on the statements, reflecting broad expert opinion.
- Public and physician benefits of CCT participation were highlighted, alongside concerns about informed consent and bias.
Conclusions:
- Controlled clinical trials are a necessity for advancing medicine and improving patient care.
- Addressing ethical dilemmas and improving trial design are crucial for maintaining public trust and clinical relevance.