Neurological Clinical Research Insitute

Overview

The Neurological Clinical Research Institute (NCRI) at Mass General Brigham is an academic research organization composed of innovative researchers experienced and passionate about designing, developing, facilitating, and conducting multicenter clinical trials in neurological diseases. Our goal is to develop new treatments for the patients we care for and for patients around the globe. We have expertise in ALS, Parkinson’s disease and other neurodegenerative diseases.

The unique strength of the NCRI is our institute’s position within one of the country’s largest hospital-based Neuroscience Research departments. The NCRI is able to leverage subspecialty experience from the Neuroscience Institute’s clinical faculty to provide the scientific leadership and collaborative approaches required to meet any complex challenges presented. Our world-renowned Harvard Medical School-based faculty are able to challenge conventional approaches and explore innovation, accelerating the translation of scientific discovery into better care for patients everywhere.

Co-founded in 1994 by Dr. Merit Cudkowicz and Dr. Steven Greenberg to conduct clinical research in neurological disorders, the NCRI develops, designs, supports and manages innovative observational and interventional trials for neurological disorders. In collaboration with the Mass General Brigham Biostatistics, the NCRI has an impressive record of rapidly and efficiently leading small and large multi-center, international clinical trials including randomized, double-blind, double-dummy and open label designs.

Mission

The mission of the Neurological Clinical Research Institute (NCRI) is to accelerate translational research in neurological disorders by initiating clinical development of novel therapies and leading trials of these compounds. We strive to be at the cutting edge of innovative trial design to accelerate therapy development by creating new trial methodology, discovering novel biomarkers and refining outcome measures.

Research Services

At the NCRI, we provide core comprehensive clinical trial infrastructure services to our collaborators. These include:

1. NeuroTherapeutics Consultations

We are happy to consult with researchers or trialists interested in initiating research projects, and/or using NCRI services. For these consultations, we draw from our broad expertise in all aspects of clinical trial design, operations, data management, and contracting to assist those seeking advice.

2. Trial Design and Biostatistics

NCRI trialists provide expert clinical trial design to enhance trial power, optimize results and ensure acceptability of a trial for participants.

3. Project Management

NCRI project management helps plan and manage the operations and regulatory aspects of complex research projects.

4. Central IRB

We have established a central IRB with existing reliance agreements with scores of academic trial sites and simple means for adding new sites. This structure provides more effective and efficient ethics and compliance oversight.

5. Electronic Data Capture

We offer longitudinal, repeatable and scalable data collection systems for projects of all sizes.

6. Data Management

Today’s research generates larger and more complex data sets than ever before. Our data management group ensures trial data is correct, clean, and high quality.

7. Site Management

The NCRI site operations team is responsible for the direct conduct of clinical trials in compliance with research protocols and is involved in the recruitment and retention of research participants. The site team consists of physicians, nurse practitioners, physical therapists, nurses and clinical research coordinators.

8. Budgeting and Contracting

Our experienced budget and contract team manage all aspects of sponsored awards, allowing investigators to focus on their research.

Our work also includes:

• Mapping the clinical development of potential therapies
• Custom design of clinical research protocols
• Bringing efficiency strategies and infrastructure to clinical research
• Providing resources, experienced staff, and services to accelerate the conduct of clinical research
• Fostering and empowering scientific collaboration
• Creating partnerships among scientific leaders with complementary backgrounds
• Establishing and managing disease-specific research consortia
• Performing high quality site-level clinical research
• Educating and mentoring future leaders in the field of clinical research
• Encouraging scientific innovation through funding

Collaborations

Mass General Brigham NCRI investigators and staff are pioneering research through their global research networks, individual labs and everything in between.

Networks and Centers

We serve as the Clinical and Data Coordinating Center and provide administrative, recruitment and retention, statistics and repository services for research networks and centers

• All ALS
• Collaborative Center for XDP
• NEALS
• NeuroNEXT
• J. Philip Kistler Stroke Research Center
• DISCOVERY
• Sean M. Healey & AMG Center for ALS
• Mass General Interdisciplinary Brain Center
• McCance Center for Brain Health
• Parkinson Study Group
• Mark VCID
• The Center for Innovation & Bioinformatics (CIB)

Individual Investigators & Research Labs

NCRI researchers work collaboratively with basic, translational and clinical researchers, innovators, and clinical trial leaders throughout the Mass General Brigham research community and around the world. NCRI facilitates the formation of collaborations and the sharing of materials and data between investigators at the NCRI with partner scientists. By developing and maintaining strong connections with a diverse group of researchers, we strive to advance neurotherapeutics and share scientific knowledge to better understand neurological disease.