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6 - The Rights of Patients to Participate in Clinical Research

Published online by Cambridge University Press:  04 December 2009

Michael A. Santoro
Affiliation:
Rutgers University, New Jersey
Glenna M. Crooks
Affiliation:
President & CEO, Strategic Health Policy International, Inc.
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Summary

RESEARCH: PROCESS AND PURPOSE

In the West, we trace the beginning of clinical research to Dr. James Lind, who in 1747 studied six treatments for scurvy on twelve sailors aboard the HMS Salisbury as it sailed from England to Plymouth Colony. The study lacked the rigor of modern clinical trials, but it was the first recorded Western instance of a documented scientific approach comparing the effects of interventions in humans.

Modern clinical research is more sophisticated than this early example, but it has the same purpose – prospective studies comparing the effect and value of an intervention against a control in human beings, requiring that an intervention be planned and applied selectively in humans to determine its impact. When properly planned and conducted, clinical trials assess the effectiveness of care and enhance treatment armamentaria. By comparing alternatives, clinical research has great potential to save lives, improve the quality of life, reform healthcare, and control costs. It is from these comparisons that conclusions are drawn about the value of an intervention.

PATIENT PARTICIPATION: IMPERATIVES AND DEMANDS

Patient participation is no small matter in today's healthcare systems, which treat both newly emerging communicable diseases and increasingly complex combinations of chronic and acute conditions afflicting young and old alike. Researchers need patients who are willing to participate in the studies that will generate answers to the questions of how to treat conditions effectively and efficiently, returning the patients to high-quality lives with good clinical outcomes at the lowest possible cost.

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Publisher: Cambridge University Press
Print publication year: 2005

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