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

Informed consumers of the 21st century increasingly will be hesitant to enr oll in randomized clinical trials (RCTs) because they will be unwilling to (a) submit to random assignment; (b) complete assessments that are too leng thy, 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 traditi onal RCTs. Recommendations for making clinical trials more participant cent ered include: (a) expanding our conceptualizations of study validity, (b) i nvolving consumers as advisers in the development and execution of clinical trials, and (c) offering participants reasonable alternatives to random as signment. (C) 2001 John Wiley & Sons, Inc.