U24HD107621

Data Coordinating Center (DCC) for the Neonatal Opioid Withdrawal Syndrome Pharmacological Treatments Comparative Effectiveness Trial (NOWS PHACET) - Project Summary/Abstract

Major knowledge gaps exist in optimizing pharmacologic treatment for Neonatal Opioid Withdrawal Syndrome (NOWS), a pressing public health issue. Rigorous, high-quality, randomized trials are urgently needed to develop the evidence base and best practices for neonatal medicine in this area.

In response, the NICHD HEAL Initiative NOWS Pharmacological Treatments Comparative Effectiveness Trial (NOWS PHACET) Consortium will design and implement a multi-center, comparative effectiveness, randomized controlled trial (RCT) to assess the optimal pharmacological treatment for NOWS that informs clinical practice guidelines.

There is a crucial need for an independent and experienced Data Coordinating Center (DCC) to provide high-quality and impartial biostatistical expertise to address the substantial methodologic challenges in the design and conduct of such a trial. The DCC will fulfill this need by:

1. Building consensus to help identify critical methodologic issues.
2. Bringing objective statistical expertise to the conception, design, and analyses of a rigorous and feasible randomized trial (with appropriate monitoring).
3. Developing processes and systems to increase the efficiency of the consortium, ensure trial feasibility, and effective use of limited trial participants and resources.
4. Ensuring standardization of study design, development, data collection, data quality, and data analyses with existing HEAL activities.
5. Dissemination of study results, public reports, and public use data.

As the longtime DCC for the NICHD Neonatal Research Network (NRN) and the ongoing Advancing Clinical Trials in Neonatal Opioid Withdrawal (ACT NOW) studies, RTI has successfully collaborated in the design and implementation of 30+ RCTs in neonates informing clinical practice.

Our specific aims as the DCC for NOWS PHACET are to:

1. Enhance the scientific rigor of the consortium by collaboratively building consensus for a uniform protocol that addresses the unique feasibility and implementation challenges of pharmacological RCTs in NOWS.
2. Optimize productivity with flexible, efficient, and high-quality data and study management, and promote HEAL data harmonization and sharing.
3. Protect participant safety and study integrity working with the independent Data Safety and Monitoring Committee (DSMC), Single IRB (SIRB), NICHD, and FDA (as needed).
4. Provide timely reporting and data analysis, and collaborate with investigators on all consortium analyses and publications.
5. Provide the necessary logistical, contractual, communications, and regulatory support.

The unique strengths of this application include:

1. A highly qualified PI and staff uniquely experienced in all aspects of both neonatal and NOWS trials, including neurodevelopmental follow-up.
2. Proven track record of collaboration and scientific productivity in perinatal studies.
3. State-of-the-art infrastructure of flexible tools, processes, and systems customized for neonatal/NOWS RCTs incorporating follow-up.
4. Multidisciplinary experts available as needed.
5. Depth and breadth of expert staff with an agile administrative structure that can respond quickly to changing needs.

Research Triangle Institute

TO CONDUCT AND SUPPORT LABORATORY RESEARCH, CLINICAL TRIALS, AND STUDIES WITH PEOPLE THAT EXPLORE HEALTH PROCESSES. NICHD RESEARCHERS EXAMINE GROWTH AND DEVELOPMENT, BIOLOGIC AND REPRODUCTIVE FUNCTIONS, BEHAVIOR PATTERNS, AND POPULATION DYNAMICS TO PROTECT AND MAINTAIN THE HEALTH OF ALL PEOPLE. TO EXAMINE THE IMPACT OF DISABILITIES, DISEASES, AND DEFECTS ON THE LIVES OF INDIVIDUALS. WITH THIS INFORMATION, THE NICHD HOPES TO RESTORE, INCREASE, AND MAXIMIZE THE CAPABILITIES OF PEOPLE AFFECTED BY DISEASE AND INJURY. TO SPONSOR TRAINING PROGRAMS FOR SCIENTISTS, DOCTORS, AND RESEARCHERS TO ENSURE THAT NICHD RESEARCH CAN CONTINUE. BY TRAINING THESE PROFESSIONALS IN THE LATEST RESEARCH METHODS AND TECHNOLOGIES, THE NICHD WILL BE ABLE TO CONDUCT ITS RESEARCH AND MAKE HEALTH RESEARCH PROGRESS UNTIL ALL CHILDREN, ADULTS, FAMILIES, AND POPULATIONS ENJOY GOOD HEALTH. THE MISSION OF THE NICHD IS TO ENSURE THAT EVERY PERSON IS BORN HEALTHY AND WANTED, THAT WOMEN SUFFER NO HARMFUL EFFECTS FROM REPRODUCTIVE PROCESSES, AND THAT ALL CHILDREN HAVE THE CHANCE TO ACHIEVE THEIR FULL POTENTIAL FOR HEALTHY AND PRODUCTIVE LIVES, FREE FROM DISEASE OR DISABILITY, AND TO ENSURE THE HEALTH, PRODUCTIVITY, INDEPENDENCE, AND WELL-BEING OF ALL PEOPLE THROUGH OPTIMAL REHABILITATION.

93.279 - Drug Abuse and Addiction Research Programs

National Institute of Child Health and Human Development (NICHD) [HHS - NIH]

National Institute on Drug Abuse (NIDA) [HHS - NIH]

Durham, North Carolina 277132852 United States

Single Zip Code

HEAL Initiative: Data Coordinating Center for the Neonatal Opioid Withdrawal Syndrome Pharmacological Treatments Comparative Effectiveness Trial (U24 Clinical Trial Required) (RFA-HD-21-032)

Amendment Since initial award the End Date has been extended from 08/31/26 to 08/31/27 and the total obligations have increased 85% from $12,000,000 to $22,225,991.