NeuroBANK™ as an Accelerated Clinical Research Environment: Development, Deployment and Services to ALS Research Community

Research Summary

Principle Investigators: Merit Cudkowicz MD & Alex Sherman

Successful implementation of NeuroBANK™ will allow for a standardized patient-centric approach to clinical research in ALS with information linked across studies, locations and modalities. Standard Common Data Elements, standard operating procedures and GUID technology will lead to accelerated studies’ review, approval, deployment and patient enrollment.

NeuroBANK™ is a patient-centric clinical research platform that allows capture and aggregation of clinical and clinical research data from simultaneously running research projects and links these data with biospecimen repositories, image banks and genetic information. Embedded Global Unique Patient Identifier (GUID) technology allows generating a patient-specific 11-character string that uniquely and securely identifies a patient without a risk of exposure of that patient’s true identity.

In general, the project consists of five components:

  • NeuroBANK™ software design, development and deployment;
  • Creation of standard operating procedures and processes, including regulatory compliance and pre-competitive guidelines; creating standardized NeuroBANK™ language on data sharing and GUID usage that could be included into any NeuroBANK™-related protocol and Informed Consent Form (ICF);
  • Service operations including research-specific study configurations, custom development, data management, data analytics and user training and support; best practices development and implementation;
  • Outreach program conception and implementation, which includes creation and dissemination of how-to materials, user guide documents, marketing materials, and advertising to researchers to analyze and request analyses of anonymized data;
  • Patient-centric tools and applications specifications requirements development, including patient-portal and social network that will eventually allow bringing patient-reported outcomes (PROs) and patient perspectives into clinical research space.

We specified three aims for the first year of the project:

Aim 1: Develop, implement and promote NeuroBANK™ as an accelerated clinical research environment that will benefit all stakeholders in the research continuum, including clinicians, researchers, patient advocacy groups, biotech and pharmaceutical companies, and PALS.

 Aim 2: Develop best practices, optimize processes in clinical care and clinical research, introduce open-ended research protocols, and approve regulatory language for research protocols and informed consent forms that could be shared by all participants.

 Aim 3: Create tools and processes to support an active and vibrant patient community that will become an equal player in the research continuum.


  • Massachusetts General Hospital
    • Alex Sherman

Impact of Study

Unlike any other platform for clinical research, NeuroBANK™ offers a patient-centric approach to research and care, in which, while a patient may be a subject in multiple clinical studies, the information from all these studies is captured in a single system, thus allowing a longitudinal view on a person. Patients’ informed consent forms will contain the same uniform language on data sharing, and similar language will be provided for all research protocols that will utilize NeuroBANK™.

Clinical research information may also be linked to biorepositories, image banks and genetic files. Data from clinical visits may also be entered into NeuroBANK™, allowing information from clinical visits to become research information. ALS-specific Common Data Elements (CDEs) will promote standardization in ALS clinical research and clinical care, as some of the CDEs are developed with clinical practice collection workflows in mind.

Standardization in the language, CDEs, workflows and processes will allow for faster protocol and consent language development, faster grant processing, lowering individual grants’ budgets, and better information quality.

The quality of data will be monitored and enforced, as the NeuroBANK™ team will provide data management, support and help desk services.


The following table illustrates the benefits of NeuroBANK™ to various stakeholders of the research and clinical care continuum:

NeuroBANK™ Advantages/To…. Investigators Clinicians Foundations Biotech/Pharma
 Time Reduction/Rapid Deployment ✓ ✓
 Standardization/CDEs/Outcomes ✓ ✓ ✓
 Data Quality via Central DM ✓ ✓ ✓ ✓
 Costs Reduction/Re-use of Resources ✓ ✓
 Data Aggregation/Data Mining ✓ ✓ ✓ ✓
 Opportunity to collaborate ✓ ✓
 Links to Bio/Image/DNA Banks ✓ ✓ ✓
 Study Patient Sub-populations ✓ ✓ ✓
 Comparative Effectiveness Research ✓ ✓
 Trial Cost Reduction (Lead-in, Placebo) ✓ ✓ ✓

Clinical Investigators will benefit from NeuroBANK™ accelerated research environment because of:

  • Faster processing of funding applications
  • Faster study approval with standardized protocols and ICFs language
  • Faster study start-up (validated library eCRFs)
  • No need to worry about electronic data capture nor data management (DM)
  • DM services are included: validated library forms, standard CDEs
  • Import existing research patient data and continue data capture
  • Aggregate and/or access large data sets previously unavailable
  • Data are linked to biospecimen, images and DNA
  • Compare patients’ disease progression against other patients and sites
  • Analyze data for comparative effectiveness research

Clinicians will benefit while collecting data at the “Bedside” as:

  • Single point of entry for clinical data may become research data
  • Captured clinical data or imported from EHR systems, may be linked and upended to research data
  • Disease progression may be charted for clinicians’ own patient population
  • They may join the research community with a minimum amount of effort and time in response to patients’ pressures and own ambitions

Research and PALS Community will benefit as NeuroBANK™ will:

  • Export data to fulfill clinicians’ obligations to external registries in required formats
  • Allow for Practice QI and comparative effectiveness analysis across sites
  • Introduce best-practice quality measures
  • Allow PALS profiling against all other patients in the network
  • Predict therapeutic outcome, bringing us closer to precise prognostication

ALS Association will benefit by:

  • Saving funds as it will be unnecessary to fund “database development” and data management services separately for each approved application
  • Faster processing of funding applications, as it will be unnecessary to analyze applications for data capture/data management services
  • Enjoying faster studies’ approval by IRBs and ethics boards as protocols and ICFs will contain standard language
  • Enjoying faster studies’ start-up
  • Enjoying faster patient recruitment
  • Not worrying about electronic data capture systems or data management
  • Assuring that the data management services are consistent and provide data of highest quality
  • Ensuring consistency of research data across multiple studies and sites
  • Direct access to clinical and research community (“democratization”)


One of the defining features of NeuroBANK™ is utilization of the Global Unique Patient Identifier, or GUID, that uniquely and safely identifies a patient in a clinical research continuum. GUID provides two primary benefits:

  • Allows patients’ clinical and research data to be aggregated and linked across clinical visits and research projects over time, regardless of where and when that data were collected
  • Enables a researcher to get information on a patient even if the data were collected by others