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Your Partner in Successful Psychiatry Trial Delivery

Your Partner in Successful Psychiatry Trial Delivery

Experience with Mental Health Research

While medical and public awareness of the prevalence and burden of mental disorders has increased, there remains a high unmet medical need.

Mental health and substance use disorders affect around 13% of the population globally. It is estimated that mental disorders are attributable to 14.3% of deaths worldwide (JAMA Psychiatry, 2015). There remains an urgent need to identify new, efficacious treatment options.

We have experience in 40 psychiatry trials across a number of indications:

  • Depression (treatment-resistant, unspecified)
  • Schizophrenia (childhood, paranoid)
  • Attention deficit disorder with hyperactivity
  • Autistic disorder
  • Opioid-related disorders
  • Neonatal abstinence syndrome
  • Psychotic disorders

Confidently Advance Your Psychiatry Clinical Trial

PPD understands how to minimize the risks inherent in psychiatry studies, particularly those associated with placebo response rates. Identification, recruitment and proper evaluation of the appropriate patients are critical factors. We apply our deep understanding in this space to overcome issues that may negatively impact signal detection, including:

  • Subjective endpoints
  • Natural history of the disease
  • Inconsistency in disease severity assessment
  • Inaccurate diagnosis
  • Misconceptions of treatment versus research
  • Expectation bias

Leading Site and Patient Access

Our advanced patient enrollment solution is based on these critical interconnected components:

  • A global proprietary database of trial participants
  • Wholly-owned clinical research sites with access to psychiatrists or neurologists
  • A network of traditional psychiatry sites

The efficiency enabled by this solution gives us the ability to reduce study timelines and provide high-quality patients, budget certainty, operational efficiency and complete accountability in achieving key performance indicators. Additional benefits for psychiatry trials include:

  • Timely recruitment and retention without impacting data quality
  • Dedicated research sites and staff better understand the nuances of patient interactions and expectations in trials
  • A reduction in study site footprint equals fewer raters and reduced data variability

Data Integrity and Scientific Surveillance

PPD’s data analytics group delivers a robust approach to data integrity protection, centralized statistical monitoring and scientific surveillance to better monitor and manage psychiatry clinical study data.

Custom-fit scientific surveillance tools in neuroscience trials include Bayesian methods to predict risks and detect inflated placebo responses. In addition, multivariate methods coupled with clinical insights are used to detect systematic irregularities across and between clinical outcome assessments, patient-reported outcomes and relevant safety outcomes such as laboratory assessments, adverse events and vitals, with appropriate multiplicity adjustments. This is translated into actions at the site- and study-level.

  • Training reinforcement for raters or caregivers
  • Increased patient and site engagement
  • Minimizing rater or caregiver changes
  • Detection of fraudulent activity, and in severe cases pausing enrollment in sites associated with elevated risks across multiple data domains