Our Clinical Trials – Case Studies

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Problem Solving for Uninterrupted Trial Progress

A Neurology Case Study

The Challenge

Worldwide Clinical Trials was retained to intervene in a Phase IIb, multinational, randomized, double-blind, placebocontrolled study, in subjects with progressive cognitive decline compatible with the diagnosis of prodromal AD.

For this highly complex study, the original CRO had failed to meet enrollment expectations due to inadequate vetting of site capabilities for this unique diagnostic category which required the use of multiple, sophisticated screening assessments which served as a “gatekeeper” for patient eligibility. The study had been launched in over 30 centers by the sponsor with virtually no patient enrollment prior to Worldwide Clinical Trials’ engagement.
 

The Solution
  • Dedicated a WCT neuropsychologist to oversee clinical monitoring, site selection and enrollment.
  • Structured the sequence of test applications for compatibility with protocol design and standard of care.
  • Reevaluated site attributes and rater qualifications for administration of battery of neuropsychological tests; many of which required specialized training in a highly
    codified sequence.
The Results
  • Worldwide Clinical Trials’ conceptual, operational and assessment services oversaw the study’s extension into neighboring countries.
  • Supervision and training by the WCT therapeutic specialist on measures that affected patient eligibility, accelerated patient randomization and the study completed one week prior to the original target date.
  • As acknowledgment of WCT’s material contribution to concepts, analysis and implementation of the study, WCT scientific staff are co-authors in an accepted article in the Journal of Alzheimer’s Disease.

Read more about our expertise in Neurology Clinical Trials.

Neurology Portfolio
Neurodegenerative Disorders (Alzheimer’s Disease, Frontotemporal

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