Clinical Research Center

Hawaii Pacific Neuroscience Clinical Research Center (CRC) proven model, and combined years of experience affords us the ability to provide Hawaii patients with groundbreaking new neuroscience treatment options.

The BRAIN Clinical Research Center is a highly sought after national clinical trial site and have a national reputation for successful completion and recruitment including rapid site start up. Its performance matrix scores at 90% of patients randomized and 95% patients completing studies. Site has a national reputation as a top-performing site and rapid site start up. It has successfully completed over 150 clinical trials and actively involved in investigations of:

NIH NINDS Funded Hawaii site for NeuroCOVID Databank/Biobank
Alzheimer’s, MCI, Preclinical and other related neurodegenerative disorders
Parkinson’s, & other movement disorders including Huntington’s chorea, tremors
Epilepsy, Seizures including acute abortive therapies in overnight EMU
MS, Neuroimmunology, Vaccine research
Headache, Migraines and Pain research
Neuromuscular including myasthenia gravis, CIDP
Concussion, traumatic brain injury
Narcolepsy, insomnia and other sleep disorders
Neurodevice, neuromodulation studies
Rare Neurological Diseases

Few recent examples of successfully investigated, FDA approved and launched products include Cenobamate for Epilepsy, Inbrija for Parkinson’s, Kesimpta for MS, Daridorexant for Insomnia in recent years.

Hawaii BRAIN ACTIVE RECRUITING neuroscience clinical trials

Fully equipped and staffed with dedicated full-time experienced research nurses, research coordinators, staff dedicated to regulatory, IRB submission, budgets and facilitates fully equipped for Phase I, II, III and IV Trial Capable with: –

Overnight PK studies in monitored unit
Biomarker (CSF, serum, genetic) sampling,
Phase 0 & Phase I Normal Volunteer and Patient Subject Studies
IV Infusion studies in IV Infusion Center
20 Exam rooms with dedicated Monitor rooms
Central IRB for Rapid Site Start Up
On-site 3T MRI
On-site Radiology Department
Onsite Spinal Tap/Fluoroscopic LP
Onsite Pharmacy
Onsite IV Infusion Center
Onsite Emergency resuscitation equipment
Central Laboratories use & experience
Accredited Local Laboratory
Refrigerated, ambient temperature centrifuge
Refrigerators -20C freezer, -70 Freezer
Onsite ABRET accredited & CliniLab certified EEG & VEEG Labs
Onsite AASM Accredited & CliniLab certified Sleep Laboratory
IATA certified Lab
Ongoing GCP training
Onsite EMG, EEG
Locked/secure Drug storage temperature controlled and monitored daily

The BRAIN clinical research site is fully integrated and collaborates closely with Hawaii Pacific Neuroscience Center with its Centers of Excellence for disease specific disorders are fully integrated so that patients have easy access to the benefits of world class groundbreaking clinical research at the Clinical Research Center specially equipped with:

Hawaii Memory Disorders Center (ALZ-NET site 6239) & Hawaii AD Infusion Center

Hawaii Comprehensive Epilepsy Center and Video-EEG Epilepsy Monitoring Unit (EMU)

Hawaii Parkinson’s Disease and Movement Disorders Center

Hawaii Headache and Facial Pain Center & Infusion Center

Hawaii Sleep and Insomnia Center (AASM Accredited Sleep Laboratory)

Hawaii ALS and Neuromuscular Center (MG Foundation of America Partners in MG Care)

Hawaii Neuroscience Infusion Center

Hawaii MS & Neuroimmunology Center
Hawaii Center for Rare Neurological Diseases

Hawaii Infusion Center

Hawaii Center for Psychiatric Neuroscience

Hawaii NeuroCOVID Clinic

Hawaii Traumatic Brain Injury Center

Hawaii Stroke and Neurologic Restoration Center

Unique Genotype contribution to National Clinical Trial Data

According to NIH NIMHD (National Institute on Minority Health & Health Disparities), one of America’s greatest challenges is reducing the profound disparity in health status of its racial and ethnic minority, rural, low-income, and other underserved populations.

For example, side effects like ARIA (Amyloid related imaging abnormalities) in the use of Alzheimer’s monoclonal antibody therapy is heavily determined by genotype including ApoE alleles. In the CLARITY trial data submitted to FDA, out of the 1792 patients in the database, only 1 was of Native Hawaiians and Pacific islanders genotype, contributed by our site.

According to 2020 US census Bureau, Asian is the 2^nd fastest growing minority after Hispanics and yet, it is one of the most under-represented groups in any US clinical trials. We believe Hawaii can play an important role in reducing the disparity in minority participation & engagement in clinical trials or research especially for minority groups as defined by NIH National Institute on Minority Health & Health Disparities (NIMHD)

Asian Americans (7% of US & over 40% of Hawaii’s population)
Native Hawaiians and Pacific islanders (10% of Hawaii’s population)
Underserved rural population (94% Hawaii’s landmass)

Hawaii is one of the most diverse US states and one of 6 states with majority minority population and home to several NIMHD designated US health disparity populations. Our team focus on promoting and collecting data on Hawaii’s diverse population to enhance scientific knowledge and designing interventions to improve health outcomes by improving health care access, reduce health disparities especially for minorities like Asians, Native Hawaiians and other Pacific islanders and underserved and underrepresented groups.