Unrivalled ability to identify, screen and randomise patients
Everyone knows the conventional wisdom. A clinical site typically contributes 0-5 patients to a study. Upwards of 25% of sites deliver no patients at all. We don’t think that’s very good. In fact, in early development, we don’t think it’s an acceptable way forward in most cases. The implication is that practically every patient study requires a massively multi-centre approach. That’s just not a great solution in early development where evaluation of complex diagnostic and laboratory biomarker parameters are critical to decision making.
Our approach, which combines access to a large and varied database with ‘direct to patient’ marketing, is able to do better – much better. Our ability to enrol is based on the % prevalence of the indication and the estimated percentage of those patients meeting defined inclusion/exclusion criteria. For indications such as SLE, Sjögren’s or MS we may be able to target up to n=30-50 patients (randomised at our unit). For indications such as diabetes, RA, Asthma we can aim at up to n=100 patients (randomised at our unit) or even beyond.
n=27 patients in a single-centre setting
- Complex biomarkers
- Labial salivary gland biopsies
- HR ultrasound parotid gland imaging
2-3 patients per month
Direct-to-patient marketing and existing database
Duration of Participation
- 4 weeks SCR
- 24 weeks treatment + FUP
- Long-term FUP