Your Partner in Delivering Successful Psychiatry Trials
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:
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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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.
Reducing Patient Burden Through Digital Solutions
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
As you focus on your mental health clinical projects, PPD is here to help. Connect with us to learn more about our experienced team.