| Autor: |
Dwyer, John, Bork, Jason, Zisko, Leigh, Goldfeder, Gabe, Trotter, Jennifer, Ritchie, Craig W., Neild, Julie, Syson, Judi, Draper, Kristy |
| Zdroj: |
Alzheimer's & Dementia: The Journal of the Alzheimer's Association; Dec2021 Supplement S9, Vol. 17, p1-1, 1p |
| Abstrakt: |
Background: The Global Alzheimer's Platform Foundation® (GAP) was launched in 2015 in response to the critical need to improve the delivery of Alzheimer's disease (AD) clinical trials. Over 80 AD sites have joined GAP's growing network (GAP‐Net). While initial efforts were focused on North America, a top priority of the platform was to develop an international trial network. Method: Development of a transatlantic site network in Europe: (1) Site identification: European sites that participated in the European Prevention of Alzheimer's Dementia (EPAD) network were approached as well as other leading sites. (2) Program identification: Sites were surveyed to understand what services were needed to improve AD trial delivery. Existing GAP programs that could be optimized in Europe with limited changes were identified along with new programs. (3) Infrastructure development: Europe‐specific agreements, regulatory strategies, and communication plans were developed to ensure alignment with the global mission. Evaluation and onboarding processes were also developed. Result: Site identification: Over 50 sites in Europe are currently onboarding. Sites are located primarily in western Europe. Program identification: Existing GAP programs that can be optimized in Europe will include accelerated study start‐up services, rater certification, transportation support, and recruiting programs (media toolkits, trial videos, social / earned media support, and regional recruitment summits). Programs that will need to be modified or developed include trial design input, prescreening support, education of primary care physicians, and advocacy group collaboration. Infrastructure development: 44 sites have returned surveys and metrics, 20 sites have been approved to join the network, and will be approached to sign the European Network Agreement. Conclusion: In partnership with leading clinical research sites in Europe, GAP has begun developing a European site network. The processes developed for GAP‐Net in North America will be leveraged to support a GAP European network that can reduce the duration and cost and improve the quality of AD clinical studies. GAP will intensify collaboration with site networks in other countries to share learning and, where possible, to implement GAP‐enabled trials. These efforts will further GAP's aim of achieving a fully global network of sites to enhance speed, efficiency, and quality of AD clinical trials. [ABSTRACT FROM AUTHOR] |
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