We detect anomalous results in subjective assessments, pinpoint the problem and intervene before variability affects costs or compromises results.

New neuropharmacologics trials have seen rapid growth in the number of procedures per trial and have one of the lowest rates of approval success at approximately 14 percent. Health Decisions’ approach to neurosciences clinical trials and programs and our data-driven operations support rapid decision-making that enables efficient execution of studies in neurological and psychiatric studies. Through Health Decisions LiveTrial Global Clinical Development System, sponsors have real-time data access, enabling rapid, effective decision making. This approach has proven effective in ensuring proper administration of subjective assessments, identifying early issues with compliance and consistency. We rapidly detect anomalous results, pinpoint the source of the problem and intervene to ensure consistent administration of assessments before variability affects costs or compromises study results.

Health Decisions’ Expertise in Neurosciences Clinical Trials and Programs

Health Decisions’ neurosciences expertise covers all phases and the following indications:

  • Addictions and substance abuse
  • ADHD
  • Alzheimer’s disease
  • Autism
  • Depression
  • Bipolar disorder
  • Brain trauma
  • Fragile X syndrome
  • Mild cognitive impairment
  • Migraine
  • Multiple sclerosis
  • Pain management
  • Parkinson’s disease
  • Schizophrenia
  • Strokes
  • Tourette’s syndrome
  • Traumatic brain injury

Design and Operational Considerations in Neurosciences Development

Health Decisions’ team of clinical experts understands the key design and operational considerations in neurosciences clinical trials and programs, including:

Design Considerations

  • Sample-size reestimation to correct not only for size of treatment effect, but also variability of data
  • Planning to cope with an evolving standard of care
  • Evaluating advantages and disadvantages of superiority and noninferiority designs
  • Early stopping for futility or efficacy
  • Exploring combined phase studies
  • Allowing for the impact of placebo response

Operational Considerations

  • Minimizing inter-rater variability with subject assessments
  • Limiting inconsistencies in subject-reported outcomes and measures
  • Addressing enrollment challenges in areas of strong patient and investigator preference for existing treatments as well as competition with other studies
  • Similarly, addressing enrollment challenges associated with reluctance of caregivers and subjects to risk randomization to placebo

View the case study of a global phase III Alzheimer’s trial.

Download a fact sheet summarizing Health Decisions’ capabilities in CNS studies.
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