What We DoThe CINRG network is a collaborative group of more than 20 sites that performs clinical studies in neuromuscular disorders. The goals of the studies that we run vary, from monitoring and observing patients over time to gain an understanding of the natural course of progression of a particular disease, to testing the safety and efficacy of a promising new drug or a drug that is used in other disease states and may work in neuromuscular disorders, to comparing the efficacy of two drugs. To date CINRG has completed a total of 9 clinical studies and is currently running several others. While most of our focus has been on Duchenne and Becker Muscular Dystrophy, we are currently running a study in Limb-Girdle Muscular Dystrophy. We hope to continue with our current research in Becker and Duchenne Muscular Dystrophy and expand into other neuromuscular disorders.
CINRG Organizational Structure
For a list of all CINRG sites around the world with the contact information for each site please click here.
CINRG Coordinating Center
The CINRG Coordinating Center (CC) works to monitor and establish both network and protocol specific standards to ensure the quality and safety of clinical research protocols run through the network. Specifically, the Coordinating Center provides study design assistance at study start as well as help in protocol writing, case report form design, database design and regulatory and ethical review. Once a study is approved, the coordinating center trains the sites on implementing the study and approves the site to allow recruitment of participants when training goals are accomplished. This includes, in particular, training of clinical evaluators at the sites on the assessments of outcomes in these studies. In addition, the Coordinating Center develops protocol specific manual of procedures, pharmacy manuals of operations and its own plans for monitoring the study progress and the sites while it is ongoing. Data quality and completeness is regularly reviewed. The Coordinating Center provides periodic data summaries to the Data and Safety Monitoring Board and also has a mechanism of alert in every study should there be a serious adverse event. At the conclusion of the study, the Coordinating Center analyzes the data and all involved CINRG members participate in its interpretation. Study results are presented at national and international meetings and are published in scientific journals. A brief description of the roles of the Coordinating Center and selected bios of key personnel are listed below.
Coordinating Center Director: Avital Cnaan, PhD
Medical Director: Paula Clemens, MD
Scientific Director: Kanneboyina Nagaraju, DVM, PhD
Clinical Evaluations (CE) Gold Standard Trainers: Tina Duong, MPT (Manager, Lead), Marisa Birkmeier, PT, DPT, PCS, Kristy Rose, MHSc, PhD, Linda Johnson, PT, NDT, Anna-Karin Kroksmark, PT, PhD and Julaine Florence, PT
The CE manager supports the CQMS system, clinical evaluators and management of CINRG outcome measures. This includes training and certification of all site evaluators, quality assurance of data from clinical evaluations, CQMS related protocol development, maintenance of adequate operations at clinical trial sites and working with the vendor(s) who develop the CQMS and its component parts.
Operations Manager: Lauren Morgenroth, MS, CGC & Project Managers: Andrea Smith, MS, CGC, Tanisha Brown-Caines, MBA, CCRC and Lindsey Vacovsky, MPH
The Operations Manager (OM) and Project Managers (PMs) support all activities related to protocol development, production and amendments, preparation and maintenance regulatory documents, manages the Coordinating Center grant and the patient care costs of the clinical trial sites, trains the clinical trial sites on protocol procedures, conducts internal monitoring as well as site monitoring visits, performs safety surveillance and facilitates communications.
Database Manager: Adrienne Arrieta, MS, Fengming Hu, MS, Jia Feng, MS, Maya Shimony, MPH, and Wenze Tang, MS
The Database Manager (DBM) designs and maintains CINRG databases, designs and produces case report forms, tracks patients and case report form collection and conducts quality assurance activities. This role supports web-based and electronic communication systems designed to facilitate communication and exchange of information within CINRG. In addition, the DBM runs quality assurance checks on the data, generates data queries from the system and resolves queries.
Biostatistician: Heather Gordish-Dressman, PhD, Marni Jacobs, PhD, Yunfei Wang, MS, MAS, DVM, DrPH, and Jichuan Wang, PhD
The Biostatistician is responsible for review and input to protocol designs and development of sample size considerations and statistical analysis plans. Once a study is approved, the biostatistician reviews case report form development and proposed database design to ensure that it is consistent with protocol and future analysis needs. The biostatistician prepares all data summary reports for the DSMB and other groups, performs data analyses on the protocols and participates in interpretation and dissemination of results through presentations and preparation of manuscripts.
CINRG Executive Committee (EC)
CINRG is led by an elected Executive Committee composed of some of the leading researchers in Neuromuscular Disorders plus some of the Principal Investigators from the CINRG Network. This combination of NMD scientific knowledge combined with an in depth understanding of CINRG provides excellent leadership for CINRG. The Executive Committee Members are listed here.
The "Sponsor" of our clinical studies, or the entity that initiates and is responsible for the study, can be CINRG itself, a company or a non-profit organization that wants to use CINRG to run a trial or a government agency that wants to fund research. Sometimes it is the collaborative efforts of some of these groups that provide the leadership and funding for a study. Not every site participates in every study as it depends on the number of patients that is needed to fulfill the statistical requirements of a study, the interest level of the site in the study goal and the particular logistical requirements a study may have. There are many federal and international rules and regulations that govern the conduct of clinical studies and CINRG prides itself in maintaining standards that meet or exceed these requirements. The FDA has more information available at ClinicalTrials.gov