Clinical trials in the 21st century: the case for participant-centered research.

Informed consumers of the 21st century increasingly will be hesitant to enroll in randomized clinical trials (RCTs) because they will be unwilling to (a) submit to random assignment; (b) complete assessments that are too lengthy, intrusive, or irrelevant; or (c) comply with protocols that do not meet their needs. Research centered on the needs and interests of participants is likely to engender greater participation and commitment than are traditional RCTs. Recommendations for making clinical trials more participant centered include: (a) expanding our conceptualizations of study validity, (b) involving consumers as advisers in the development and execution of clinical trials, and (c) offering participants reasonable alternatives to random assignment. Copyright 2001 John Wiley & Sons, Inc.