Are normal healthy research volunteers psychologically healthy? A pilot investigation.

摘要: Most new drug development in Phase I clinical trials relies on the use of “normal healthyresearch volunteers” (NHRVs); however, little is known about personality functioning ofthese volunteers. Determining whether NHRVs are similar to or different from individualswith “normal” personalities can impact participant recruitment, group assignment, andstatistical interpretation study results. This pilot was undertaken gain insight intothe demographics, functioning, and potential psychopathology volunteerswho participated a connement trial. ( N 28) an all-male,Phase trial completed battery questions, including Minnesota MultiphasicPersonality Inventory–2 (MMPI-2) sociodemographic questionnaire. Fifty percent ofthe sample showed clinically signicant elevations at least one scales. Currentndings need be replicated expanded through future research. Results must beinterpreted with caution because small, all-male sample. preliminary studysuggests that there difference between generalpopulation. In addition, may purposefully distort conceal self-report informationwhen participating studies.Keywords: trials, pharmacology, healthy volunteers, normal volunteer personality, research volunteers