PPD’s experience in the past five years:
PPD has a deep understanding of the challenges of dermatology drug development
- Early phase through post-approval experience
- Cross-functional experience to drive endpoint quality, ensuring top-tier investigator and project team training and rater consistency
- Experience recruiting and retaining pediatric and rare populations
- Biosimilars experience
CONSISTENT ENDPOINT ASSESSMENTS
The qualitative nature of many dermatological indications, including psoriasis, atopic dermatitis and acne, means that endpoint data are frequently derived from visual descriptions of observations from an investigator-trained eye versus more quantitative results. This variability requires consistent objective methods in order to build confidence in the quality of trial data and ensure reproducibility and translation to clinical practice.
We have deep experience putting a plan in place that leverages strategies such as rater training to help ensure rater consistency.
Expanding Patient Access to Dermatology Studies
Many dermatology indications, including psoriasis and atopic dermatitis, must contend with significant competition for patients and site resources globally. We dramatically shift the recruitment paradigm with our Accelerated Enrollment Solutions delivery model. We use our database of 100 million households with known medical conditions to identify actual patients in advance of study startup. This database includes 4.9 million households with eczema and four million households with psoriasis. Interviews with these households not only provide us with insights that strengthen our ability to recruit the right patients for your trial, we can then refer those precise patients directly to study sites.