Enrolling large studies in healthy volunteers
Charité Research Organisation has a substantial database of healthy volunteers. We supplement this with study-specific marketing. Typically, we are randomising n=24-80 subjects for individual studies. However, we are also enrolling many more subjects for certain types of studies. For example, Phase I biosimilar studies often require us to randomise more than n=200 healthy subjects. Nutritional intervention studies often require more than n=300 subjects to be recruited, screened and randomised. As with patients, efficiently enrolling large numbers of healthy volunteers requires a fundamental understanding of the challenges presented by different types of studies.
For instance, First Time in Human studies present different challenges to biosimilar studies. First Time in Human studies typically utilise a dose escalation design. This means volunteers are often asked to be particularly flexible in terms of the timing of their participation. Additionally, no prior clinical data is available to present to volunteers.
Biosimilar studies have a different design. This allows more predictable planning in terms of timing of participation. However, the availability of extensive adverse event data for the marketed biologic requires that special attention is needed when explaining it to the volunteers.
Clinical Pharmacology (Biosimilar)
n=210 subjects in a single-centre setting
- Expedited timelines
- 5-day in-house period for 12 subjects per week
- Strict lab ranges at SCR
12 per week
Direct-to-subject marketing and existing database
Duration of Participation
- 4 weeks screening
- 5 days in-house for dosing
- 8 weeks follow-up