Core B: Clinical Translational Core

NIH RePORTER · NIH · P50 · $208,913 · view on reporter.nih.gov ↗

Abstract

The Clinical Translational Core B will: (1) enable intellectual and developmental disabilities (IDD)-related clinical research to accelerate translational studies of the causes, associated clinical features, and new interventions in IDD; (2) incorporate non-traditional approaches into IDD research, including pragmatic clinical trials within learning healthcare systems and remote interventional studies and (3) enhance inclusion of IDD populations into ongoing (non-IDD) research studies by providing investigative teams with the necessary tools and trainings to support these populations. These efforts will facilitate inclusion of people with IDD into ongoing clinical and translational research, especially in studies from which they have previously been excluded. The Core’s services include (1) hands-on support to IDDRC research teams in the form of targeted consultations that tailor “condition-agnostic” Vanderbilt resources such as the Recruitment Innovation Center, which implements recruitment and retention strategies for clinical trials, to the needs of IDD populations; (2) maintenance and expansion of two research registries, one for autism spectrum disorder and one for Down syndrome; (3) consultation on data pulls for electronic health records and genetic databanks; (4) various methods to enable remote research, including online research portals and telehealth research approaches; and (5) hands-on support to non-IDD research teams to enhance inclusion in studies, including modifying Electronic Consent (eConsent) for IDD populations. These services are both responsive to investigator needs as well as generative in adding value to IDD research locally and nationwide, via dissemination through national networks. Overall, Core B’s services are focused on encouraging non-traditional researchers (e.g. those not working on IDD) to become engaged in IDD research; enables research involving non-traditional participants (e.g. people with IDD typically excluded from ongoing clinical research); and facilitates the use of non-traditional approaches (e.g. pragmatic trials, remote research) into IDD research efforts. Thus, Core B’s activities enable IDD research to be conducted optimally from study design to recruitment/consent, to implementation, and also expands efforts to more appropriately represent those with IDD in non-IDD ongoing research studies. Together these activities will accelerate IDD-related discoveries that will lead to high-impact interventions and treatments, thus improving the lives of those with IDD and families.

Key facts

NIH application ID
10915489
Project number
5P50HD103537-05
Recipient
VANDERBILT UNIVERSITY MEDICAL CENTER
Principal Investigator
BETH A MALOW
Activity code
P50
Funding institute
NIH
Fiscal year
2024
Award amount
$208,913
Award type
5
Project period
2020-08-06 → 2027-05-31