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Outcomes
- Effective study design and patient management leading to high patient retention (only 4% discontinuation).
- Patient recruitment was completed on time without any advertisement despite longer timelines associated with academic sites and the institutional burden.
Study Characteristics
- Disease Focus: Systemic Sclerosis (SSc), including subgroups Raynaud’s Phenomenon (RP), Limited cutaneous SSc (lcSSc), and Diffuse cutaneous SSc (dcSSc).
- Patient Demographics: 49 patients with diverse geographic distribution.
- Study Design: Biopsy-based research requiring 2 or 4 x 3mm biopsies per patient; no treatment was offered as part of the study.
Study Challenges & Solutions
Challenge #1 – Recruitment
The absence of an active treatment arm made the study less appealing to potential participants.
Solution: Leveraged the site’s comprehensive patient database to identify and recruit eligible patients.
Challenge #2 – Logistics
- Many participants traveled long distances for study visits, with some living more than 2h away.
- Biopsies were conducted at a separate institute, requiring patients to attend 2 locations for each visit.
Solution: Successfully coordinated complex logistics, including transportation support for patients from remote areas and seamless scheduling across multiple facilities.
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