14 - Trial Site Infrastructure and Management: Importance to Alzheimer’s Disease Drug Development

Summary

The path to approvability of drugs created for Alzheimer’s disease (AD) dementia, mild cognitive impairment, or associated symptoms of AD is long and expensive, involving the study sponsor, the registration authorities, a clinical research organization, and the performance site. The key to successful AD trials is the performance site, the individual investigators, the recruited subjects, and the quality of the data generated. Performance sites include academic medical centers, a division within a large multi-specialty group, and for-profit clinical trial companies. All performance sites have common elements. These include the staff (investigator, coordinator, rater/neuropsychologist, and manager), access to study participants for enrollment, appropriate training of staff, regulatory oversight (investigational review board ), and the ancillary services. Types of studies that are available include therapeutic (medication or device), longitudinal observational, and imaging. Different types of studies have different requirements for staff or infrastructure, some easy to deploy, others not. In this chapter we will describe the elements of a successful AD clinical trial site.