Expertise in Psychiatry Clinical Trials

OVERVIEW

Worldwide Clinical Trials is the leader in CNS clinical research. Our tradition of excellence is founded on therapeutic expertise in CNS disorders, especially
psychiatry.
 
Our team’s experience in CNS clinical research is unsurpassed. Our leadership team has published more than 400 articles in peer reviewed journals and authored more than nine textbooks in the field of CNS pharmaceutical research, including a release on optimizing critical pathways in CNS drug development. We have participated in the design, execution, or analysis of 80 trials in a variety of psychiatric disorders since 2008.
 
These trials were conducted mainly in Eastern Europe (Russia, Ukraine, Serbia, Bulgaria, Romania and Croatia), and also in Argentina, Australia, France, Poland and the United States at more than 500 sites and included over 4,200 randomized patients.
 
Our operational staff and clinical assessment teams are exceptionally familiar with the use of appropriate diagnostic and outcome measures to evaluate a variety of psychiatric symptoms. We have worked with various proprietary and commercial rater response systems and has utilized several systems to assess rater agreement with patients’ self-reports on various scales, including
the SCID-CT, MINI, HAM-D, YMRS, MADRS, BPRS, and PANSS. We also recognize the importance of choosing the appropriate assessment battery to measure cognitive deficits in CNS disorders and the correct application of test instruments when assessing cognition in psychiatric disorders such as schizophrenia. Worldwide Clinical Trials teams have extensive experience working with the CANTAB, CogState, and CDR computerized cognitive batteries (among others) on numerous psychiatric trials.
 
OUR DIFFERENTIATORS IN PSYCHIATRIC DISEASES INCLUDE
  • • Extensive experience and expertise across various psychiatric disorders
  • • Experience in conducting clinical trials in psychiatry with >4,200 patients enrolled since 2008
  • • Established network of over 100 highly qualified investigators
  • • State-of-the-art international rater training and clinical assessment team
  • • Exceptional operational capabilities in the Central and Eastern Europe region, with outstanding enrollment/retention metrics in Central and Eastern Europe; expertise in medical aspects and outcome measures most widely utilized in psychiatric clinical trials
OPERATIONAL EXCELLENCE IN EMERGING REGIONS
Central and Eastern Europe has a long tradition of successfully conducting psychiatric studies. This region has an established network of highly qualified psychiatrists and has a large number of psychiatric patients available across disease stages, as well as unprecedented access to an untapped pool of treatment-naïve patients eager to enroll in studies. Given the unique treatment
practices, sites in this region often boast very high enrollment numbers with exceptionally low attrition rates of fewer than 5% (even in bipolar and schizophrenia outpatient studies where attrition rates have exceeded 50% in western countries). Recent data from our clinical assessment team shows that PI raters from this region have similar measures of dispersion and bias from gold
standards as their western counterparts, suggesting highly capable site raters. Another unique characteristic of conducting trials in this region is the fact that the majority of Worldwide Clinical Trials CRAs working in the CEE region are medical doctors and have trustful relationships with investigative sites.

 

CASE STUDIES

Psychotic Disorders
A Phase II inpatient study of acutely exacerbated schizophrenic patients (N=205) was awarded to Worldwide Clinical Trials over two large CROs (both preferred providers) based largely upon a protocol-specific feasibility assessment at each center where the protocol was to be implemented, deliberately highlighting design issues that potentially could affect patient accrual, retention, or other qualitative aspects of the trial. Practical site and country-specific suggestions on diagnostic, outcome, and operational measures prior to the initiation of the trial were highlighted in a process of pre-emptive trial management. Another representative clinical study in mood disorders is an ongoing Phase II double-blind, placebo-controlled, flexible-dose-design study evaluating the efficacy and safety of a novel antidepressant in patients with severe depression (Hamilton Depression Rating Scale (HAM-D) >24). In addition to typical endpoints such as the Quick Inventory
of Depressive Symptomatology – Self Report (QIDS-SR) and the Bech Melancholia Scale, this Russian study also is investigating preliminary pharmacokinetic/pharmacodynamic biomarker relationships for a new antidepressant in subjects with major depressive disorder (MDD).
 
Depression/Smoking Cessation
Contracted for protocol development and consultation services we participated in a unique Phase IV project at our inpatient facility. This trial randomized 110 subjects in six cohorts to a 12-week treatment period with both inpatient and outpatient treatment periods. Worldwide Clinical Trials staff assisted the sponsor with study design, selection and training on clinical assessments, and analysis/interpretation of study data, most notably the use of the Profile of Mood States via IVRS. This proprietary system featured an outbound patient reminder call system and automatic email alerts notifying study staff of significant depression symptomology using predetermined thresholds as a surrogate for suicidality and agitation/aggression.