Psychiatry Clinical Trials and Mental Health Partnership

Therapeutic Expertise Neuroscience Research Psychiatry

Global experience with mental health research

The importance of mental health has increased within the medical community and the public at large, but the need for psychiatric treatments remains high.

Mental health conditions and substance use disorders affect roughly 13% of the global population and are attributed to 14.3% of deaths worldwide. There is an urgent need among patients and their loved ones for effective, novel treatment options for mental health conditions.

There are a number of challenges you may face in mental health clinical projects—but as your CRO partner, PPD enables you to manage the specific challenges that may arise, such as subjective assessments, inter-rater reliability, scale validation and placebo response rates. Our psychiatric experts have experience designing and executing trials for various mental health disorders related to:

behavior
cognition

maladaptation
mood

perceptions

The medical experts at our Rare Disease and Pediatric Center of Excellence (COE) focus on treating rare and pediatric conditions, including childhood psychiatric disorders such as autism and Rett syndrome.

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Experience in 50 psychiatry trials across a number of indications:

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

Psychiatry studies

Sites

Patients

Confidently advance your psychiatry clinical trial program

Minimizing the risks inherent in psychiatry studies—such as placebo response rates—without having to compromise on identifying, recruiting and properly evaluating the appropriate patients is vital to your study. To proactively overcome issues that may negatively impact signal detection, we apply our cross-functional expertise in risk mitigation including:

Expectation biases
Inconsistencies in disease severity assessment
Misconceptions of treatment versus research
Natural histories of the disease
Subjective endpoints

Leading site and patient access

Through our advanced patient enrollment solutions—which optimize recruitment and retention without impacting data quality—PPD is able to reduce your psychiatry clinical study timelines. Our advanced patient enrollment solutions are based on three crucial, interconnected components:

Fully-owned sites with psychiatrist/neurologist access

Network of traditional psychiatry clinical research sites

Proprietary global database of clinical trial candidates

These patient-minded services increase your access to high-quality candidates while also providing budget certainty, operational efficiency and accountability in achieving key performance indicators.

A reduction in study site footprint means fewer raters and, therefore, reduced variability in data. Because of their extensive experience in psychiatry, the staff members at our dedicated research sites have a deep understanding of mental health patient interactions and expectations in psychiatry trials.

Study data integrity and scientific surveillance

PPD’s data analytics group delivers robust approaches to data integrity protection, centralized statistical monitoring, and scientific surveillance to better monitor and manage psychiatric clinical study data. Custom-fit scientific surveillance tools in psychiatry and neuroscience trials translate into action at the site and study levels. These tools include:

Bayesian methods for predicting risks and detecting inflated placebo responses
Multivariate methods coupled with clinical insights for detecting systematic irregularities, with appropriate multiplicity adjustments, across and between:
- Clinical outcome assessments
- Patient-reported outcomes
- Relevant safety outcomes including laboratory assessments, adverse events and vitals

To ensure consistency in studies at all levels, PPD also offers site support services for researchers and staff, which include:

Detecting fraudulent activity, and in severe cases pausing enrollment in sites associated with elevated risks across multiple data domains
Increasing patient-site engagement through e-consent and patient concierge services
Minimizing rater and caregiver changes
Site training and support
Training reinforcement for raters and caregivers

Your Partner in Delivering Successful Psychiatry Trials