About Us | Hawaii Clinical Research Center

Clinical Trials continued

Gynecology; Acute Pelvic Infection

Phases Conducted	Total Number of Studies to Date
Phase II and III Inpatient	1
Hawaii Clinical Research Center affiliates with gynecologists in the local community interested in research. Recruitment comes from a variety of sources including advertising, patient population, physician referral and strong networking.

Infectious Diseases; Strep Throat, Community-Acquired Pneumonia, and Influenza

Phases Conducted	Total Number of Studies to Date
Phase II, III, IV Outpatient	4
Letters, referrals and networking with our internists have helped in patient recruitment for this indication.

Neurology - Migraine Headaches, Dementia, Alzheimer’s

Phases Conducted	Total Number of Studies to Date
Phase II, III, IV Outpatient	10
Hawaii Clinical Research Center has access to adolescent, adult and elderly study populations. We have the ability to use nursing homes settings as well as conducting the trial in an outpatient setting. Methods of drug administration have included oral as well as injectable formulations generally with a drug vs. drug study design.

Orthopedics; Prevention of thromboembolism with elective hip and knee replacement

Phases Conducted	Total Number of Studies to Date
Phase II and III Inpatient	3
As with other specialty areas Hawaii Clinical Research Center affiliates with local gastroenterologists. Recruitment comes from a variety of sources including advertising, patient population, physician referral and strong networking.

Panic, Generalized Anxiety, Post Traumatic Stress Disorder and Borderline Personality Disorders

Phases Conducted	Total Number of Studies to Date
Phase II and III Outpatient	28
Hawaii Clinical Research Center has worked with adolescent, adult and elderly populations in these study indications. Placebo controlled and drug vs. drug study designs have been conducted. Patient recruitment comes from advertising, which is very effective, as well as working with local mental health groups and organizations, and physician networking.

Pharmacokinetics, Pharmacodynamics, Biomarker and Genotyping, With On-Going Trial or Stand Alone

Phases Conducted	Total Number of Studies to Date
Phase I, II, III and IV	60 plus
Many of our studies have included specific specimen collection for further research. Hawaii Clinical Research Center has strong capabilities in this area. We have a -70° freezer for storage, refrigerated centrifuge and contracts with many couriers’ services to provide direct shipment of these specimens while maintaining their integrity

Phase I - Healthy Human Trials, Pharmacokinetic, Safety and Efficacy and Comfort studies

Phases Conducted	Total Number of Studies to Date
Phase I	15
Hawaii Clinical Research Center has conducted several Japanese bridging studies that have included both Japanese only subjects or studies with equal comparison of Caucasian counterparts. Total numbers of study subjects have ranged from twelve subjects to eighty plus subjects in these trials. Other studies have focused on safety and efficacy and pharmacokinetic sampling done at multiple time points. Inpatient stays have lasted as long as fifteen days in duration. Our current database of Japanese well exceeds 600+ with growth daily. Phase I research is a big interest to The Hawaii Clinical Research Center and the community. We have a thirty bed residential Phase I unit and our center is equipped with a -70° freezer for storage, refrigerated centrifuge and capabilities for handling all pharmacokinetic and other laboratory specimens. Experience with our local labs has also been an asset in successful collection and processing of safety laboratory specimens with electronic submission capabilities.

Schizophrenia, Schizoaffective, Schizophreniform and Psychosis

Phases Conducted	Total Number of Studies to Date
Phase II, III, IV Inpatient and Outpatient	53
Hawaii Clinical Research Center is experienced with both placebo-controlled studies as well as drug vs. drug comparisons. Methods of drug administration have included oral as well as injectable formulations. Areas of study have been with general schizophrenic populations, treatment resistant patients and those who have agitation associated with the disorder. The duration of these studies has ranged from several weeks to six-week inpatient stays. Many of the trials were designed with open label long-term extensions.