Participant recruitment and retention into randomized controlled trials (RCTs) is a growing and evolving science. It varies dramatically by discipline given the important and key choices that must be made based on the unique trial design considerations. In the field of Alzheimer’s Disease (AD) therapeutics, recruitment goals, approaches, and strategies vary based on the disease stage of the target population which can range from asymptomatic adults with biomarker evidence of the disease to end-stage symptom management. This chapter discusses existing barriers and provides recommendations to achieve inclusive and timely recruitment in multi-center AD trials. It proposes an evidence-based recruitment framework anchored on culturally cognizant and participant focused study level and study site level efforts.

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Achieving Inclusion in Pharmacological Clinical Trials for Alzheimer’s Disease

  • Doris Molina-Henry,
  • Rema Raman

摘要

Participant recruitment and retention into randomized controlled trials (RCTs) is a growing and evolving science. It varies dramatically by discipline given the important and key choices that must be made based on the unique trial design considerations. In the field of Alzheimer’s Disease (AD) therapeutics, recruitment goals, approaches, and strategies vary based on the disease stage of the target population which can range from asymptomatic adults with biomarker evidence of the disease to end-stage symptom management. This chapter discusses existing barriers and provides recommendations to achieve inclusive and timely recruitment in multi-center AD trials. It proposes an evidence-based recruitment framework anchored on culturally cognizant and participant focused study level and study site level efforts.