Our approach and expertise
At Parexel, our approach to studies for treatments for dermatology disorders is driven by a deep understanding of the challenges in the patient population, including young people and children. Creating the right environment for patients and understanding their motivations, especially in early-phase studies, is intrinsic to our work. They know better than anyone the range of physical, emotional, and financial burdens they experience, as well as the frustrating search for effective relief.
Atopic dermatitis
For people affected by atopic dermatitis – those afflicted by this debilitating condition as well as their families – the high volume of active research for treatments is encouraging and reassuring. Researchers, however, face a very different challenge: intense competition. Globally, more than 150 industry-sponsored, Phase I-IV interventional studies focused on atopic dermatitis ( eczema) are currently open and planned, all recruiting adults or adults combined with children. Moreover, these trials are especially complex because of the nature of the disease and the subjectivity of endpoints assessments. Securing data quality must be a top priority, as well as ensuring adherence and commitment to the trial through proper scheduling and patient comfort. There is simply no substitute for experience in this area.
The Parexel team has gained deep operational knowledge from the successful delivery of 69 global trials for atopic dermatitis in the past 5 years, including first-in-class biologic approval. We provide a blueprint for achieving trial objectives via a profound understanding of the patient experience, proven site-activation strategies, and real-time data-driven monitoring.
We target sites that are top enrollers and express interest in early-phase studies, even those of a short duration. Benchmarking analysis and historical data help us identify overall enrollment trends in moderate-to-severe atopic dermatitis trials, which guides site selection using our well-established networks. Along with a robust feasibility and qualification process, patient-centric study setup, and thorough investigator training, this approach has a dramatic effect on mitigating screen failure and boosting patient retention.
Likewise, securing data quality requires an expert understanding of trial setup, oversight, and real-time monitoring to control rater consistency, screen-failure scores, attrition rates, and placebo response. All of this is crucial for accelerating timelines and demonstrating drug efficacy at the trial’s conclusion.
For a recent early-phase trial, for example, we earned a 10/10 client satisfaction score for delivering full enrollment within one month of the site initiation visit, with first patient screened on Day 1. We achieved >90% e-diary compliance across 6,000 patients using real-time alerts, bring your own device options, and continual oversight by clinical operations teams.
Parexel is uniquely positioned to support trials in atopic dermatitis a cross all phases. Our therapeutically aligned cross-functional operational teams, including project and clinical operations leaders, feasibility specialists, and biostatisticians, deliver integrated solutions from protocol design through database lock. These teams include more than 200 clinical research associates, each with more than 5 years of experience specifically in atopic dermatitis trials, and a team of Board-certified dermatologists in the EU, U.S., and Asia-Pacific regions.