Department of Neurology, University of Kentucky College of Medicine, Lexington, KY 40536, USA.
Alzheimer Dis Assoc Disord. 2010 Apr-Jun;24(2):165-70. doi: 10.1097/WAD.0b013e3181aba927.
Inefficient and delayed recruitment into clinical trials in Alzheimer disease are major obstacles impeding progress in the discovery of more effective therapeutic strategies to combat this disease. Despite widespread recognition of this problem, limited empirical data demonstrating the effectiveness of specific recruitment strategies are available to guide recruitment endeavors. This study was designed to evaluate the effectiveness of recruitment efforts targeting either the primary care health professionals (PCPs) or patients and families with a community grass-roots outreach event. The primary outcome measure was actual study recruitment and participation in the 4 months postintervention. No research subjects were recruited from the PCP intervention, whereas 69 subjects were recruited into clinical studies from the community grass-roots outreach event activity (0% vs. 28%, P<0.0001, Fisher exact test). Barriers to recruitment success in the PCP arm included a perception of perceived harm to subjects from research participation and fear of losing patients through clinical research participation. Our results suggest that outreach efforts directed at the potential study subject/caregiver are not only cost-effective but are able to easily accomplish the desired result of direct recruitment into clinical research studies.
阿尔茨海默病临床试验的招募效率低下且延迟,这是阻碍发现更有效治疗策略以对抗这种疾病的主要障碍。尽管普遍认识到这个问题,但可用的指导招募工作的具体招募策略的经验数据有限。本研究旨在评估针对初级保健卫生专业人员(PCP)或患者和家庭的社区基层外展活动的招募效果。主要的观察指标是干预后 4 个月的实际研究招募和参与情况。PCP 干预组没有招募到研究对象,而社区基层外展活动招募了 69 名临床研究对象(0%比 28%,P<0.0001,Fisher 确切检验)。PCP 组招募成功的障碍包括对研究参与者的潜在伤害的感知和对通过临床研究参与失去患者的恐惧。我们的结果表明,针对潜在研究对象/照顾者的外展工作不仅具有成本效益,而且能够轻松实现直接招募到临床研究的预期结果。