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Clinical trial: a clinician's perspective.

W E Richenbacher¹

¹Division of Cardiothoracic Surgery, The University of Iowa College of Medicine, Iowa City, USA.

ASAIO Journal (American Society for Artificial Internal Organs : 1992)

|February 10, 2000

Summary

This study redefines the clinical trial process, focusing on patient well-being and intellectual curiosity over potential fame or financial gain. It emphasizes offering innovative therapies safely and effectively.

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Area of Science:

Clinical Research
Medical Innovation
Patient Care

Background:

Principal investigators (PIs) participate in clinical trials for various reasons, including intellectual curiosity and offering novel treatments.
Motivations like fame and fortune present potential downsides, including reputational risk and financial strain on departments.

Purpose of the Study:

To present a revised algorithm for the conduct of clinical trials, based on practical experience.
To highlight the primary motivation for conducting trials: providing patients with access to innovative therapeutic modalities.

Main Methods:

The study outlines a conceptual algorithm for clinical trial conduct.
Specific excluded elements include device development, regulatory approvals, and site selection processes.

Main Results:

The revised algorithm focuses on the operational aspects of conducting a trial once a site is established.
It emphasizes the PI's role in ensuring patient safety and well-being throughout the trial.

Conclusions:

Patient well-being and the ethical conduct of trials are paramount.
Intellectual curiosity and the drive to offer new therapies are key motivators for PIs, balanced with a realistic perspective on potential challenges.

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