Clinical Coordination and Data and Statistics for Studies of the National Drug Abuse Treatment Clinical Trials Network

NIDA Clinical Trials Network, 3UG1DA040309-11S2

8/1/25-2/28/30

Lisa A. Marsch, PhD (Northeast Node of the CTN, Center for Technology and Behavioral Health, Geisel School of Medicine at Dartmouth); Jennifer McCormack, MS (The Emmes Company, LLC; Data and Statistics Center [DSC]); N. Robrina Walker, PhD (The Emmes Company, LLC; Clinical Coordinating Center [CCC])

Scientific Officers: Landhing Moran, PhD, NIDA CCTN; August Holtyn, PhD, NIDA CCTN.

Research Team: Bethany McLeman, BA (Northeast Node; Node Coordinator); Chantal Lambert-Harris, MA (Northeast Node; Project Director); Emma Fredyma, MPH (Northeast Node; Research Coordinator); Kathryn Hefner, PhD (The Emmes Company, LLC; DSC); Eve Jelstrom, CRNA, MBA (The Emmes Company, LLC; CCC); Steffanie Wilson, PhD (The Emmes Company, LLC; CCC).

The National Institute on Drug Abuse (NIDA) Clinical Trials Network (CTN) was established in 1999 to bridge the gap between research and practice to improve substance use disorder treatment. The CTN aims to address novel and timely research questions directly relevant to clinical practice and the needs of people living with substance use disorders (SUDs). Studies conducted in the CTN are typically multi-site clinical effectiveness or hybrid clinical effectiveness/implementation trials aligned with NIDA’s key areas of interest. This research agenda evolves as the landscape of the SUD treatment community in the US shifts, health care systems transform, and new scientific advancements emerge.

The objective of this award is to provide clinical coordination and data/analytical support for studies funded by the National Drug Abuse Treatment Clinical Trials Network through a collaboration with a contracted research organization (CRO) that is experienced in multi-site clinical trials focused on substance use disorder.

The Emmes Company, LLC, is a Contracted Research Organization that was founded in 1977 with a well-established history as a scientific partner to many divisions within the US government, including the National Institutes of Health (NIH). The Emmes Company, LLC, has been a CRO of the CTN since its first trial launched in 1999. Emmes has provided support to CTN Nodes primarily through its Clinical Coordinating Center (CCC) and Data and Statistics Center (DSC).

This project will provide clinical coordination and data and statistical management for multiple CTN studies focused on substance use disorders. This will include all services provided by Emmes for covered CTN trials. This project will provide clinical and data/analytical support for CTN trials; study oversight will be the responsibility of each individual study’s lead investigative team. In accordance with the parent cooperative agreement (UG1DA040309), the Northeast Node of the Clinical Trials Network will collaborate with partners at NIDA to oversee all aspects of services provided by The Emmes Company, LLC.

Clinical and data and statistics management are vital scientific contributions to the ongoing achievements made by the CTN towards seminal research on substance use disorders. This project will supply needed efforts by Emmes to efficiently develop, conduct, analyze, and disseminate key learning from the NIDA CTN.