Use of addictive substances impacts several hundred million people worldwide. The United Nations World Drug Report 2020 estimates that in the period 2009–2018 the number of past-year users of any drug grew from 210 million to 269 million globally, representing an increase of more than 25%. Among the 269 million, 35 million suffer from drug use disorders, with one in seven being able to access treatment.
Likewise, Alcohol Use Disorder (AUD) contributes to significant disease and mortality. An estimated 283 million people are affected by AUD worldwide, with the highest percentage in Europe and the Americas, and lowest in the Middle East and Africa. Harmful alcohol use results in 3 million deaths each year, approximately 5.3% of all deaths globally. It is related to more than 200 diseases and disproportionately impacts people 20-39 years old. Treatment coverage for AUD rises globally in proportion to national income, with lower income countries having almost no access to treatment.
Clinical Research Experience
Over the course of 20 years, Emmes has developed strong networks and relationships with organizations and key opinion leaders across a variety of settings (e.g., primary care, emergency departments, community based outpatient specialty clinics, and rural treatment centers) involved in clinical research and treatment relating to substance use.
As part of our mission to advance the public health, we partner with institutions such as the National Institute of Drug Abuse (NIDA) to address the challenges of substance use. For over fifteen years we have supported the NIDA National Drug Abuse Treatment Clinical Trials Network (CTN), operating as its Clinical Coordinating Center beginning in 2005 and its Data and Statistics Center since 2009.
Emmes has experience with many of the pharmaco-therapeutic agents and behavioral interventions used to treat substance use. Our experience includes 50+ studies across a variety of substance use disorders, including opioids, methamphetamine, cocaine and other stimulants, cannabis, and drug/alcohol combinations.
In addition to managing clinical research studies, Emmes’ experience includes collection, management and analysis of TimeLine Followback (TLFB) data; standardization work leading to the creation of substance use-related Common Data Elements; and supporting data harmonization. Currently we are focused on research funded by the NIH HEAL Initiative to combat the national opioid public health crisis.
A Sample of Emmes’ Experience
in Substance Use
|Clinical Coordinating Center for NIDA Clinical Trials Network (CTN) 2005-present||Full service CRO support for clinical trials management and other NIDA initiatives||Full service clinical trial management, protocol development, site management, safety monitoring, trial logistics, regulatory support, QA, data management, analysis, reporting, regulatory affairs, publications|
|NIDA CTN Data and Statistics Center, 2009-present||Full service statistical and data management support||Study design, statistical support and analysis, data management, trial monitoring, reporting|
|NIDA Common Data Elements (CDEs)||Manage the effort to establish CDEs relating to substance use||Create CDEs, collaborate and manage personnel involved in CDE process, create and manage the NIDA CDE website, develop instruments included on the Data Standards Registry and Repository and an Emmes’ developed NIDA website|