Data solutions provider TARGET PharmaSolutions has commenced a large-scale observational trial called TARGET-DERM to obtain real-world evidence for immune-mediated inflammatory skin conditions (IMISCs).
TARGET-DERM will initially focus on atopic dermatitis (AD/eczema). Its design is disease-focused rather than treatment-specific, for enabling capture of natural history and outcomes data continuously.
The trial will gather retrospective and prospective data over three years and five years, respectively, on a total of up to 15,000 adult and paediatric patients at about 100 sites across the US.
The collected data is set to include patient reported outcomes (PROs), with new therapies entering the market and clinical programmes evolving.
This data will be made available on a biorepository that can be accessed by TARGET-DERM stakeholders for genomic studies and translational research.
In addition, the trial will develop a research registry of IMISCs patients within academic and community real-world practices. The registry is intended to study the safety and effectiveness of existing as well as future therapies.
Icahn School of Medicine dermatology department vice-chair Emma Guttman-Yassky said: “TARGET-DERM is a unique opportunity to better understand the natural history of AD and other diseases and to evaluate different treatment regimens, outcomes and adverse events across a large, diverse patient population.
“It is our hope that this research can better inform how these conditions are approached and ultimately improve the lives of the millions of people who suffer from them.”
Guttman-Yassky is part of an academic steering committee that will lead the observational trial.
In the future, the trial will be expanded to additional skin conditions – hidradenitis suppurativa, alopecia areata and vitiligo.