Case Study – Hematology: ODC Implemented a High-Touch Recruitment Model to Make Brazil a Decisive Late-Stage Accelerator in a Global Rare Hematology Trial
Challenge The sponsor needed to recruit patients with myelofibrosis and severe thrombocytopenia (platelets <50,000/μL) for the Phase III PACIFICA trial evaluating pacritinib. This is one of the rarest and most clinically fragile MF subgroups — with an estimated incidence of ~0.3 per 100,000 — The trial was enrolling patients since 2019 and included Brazil only in 2025 as part of a rescue strategy.
Strategy
- Mapping the Right Hematology Ecosystem: Prioritized high-volume MPN referral centers with established cytopenic MF patient pools and referral relationships to surface rare eligible patients.
- Structured Eligibility Funnel: Converted PACIFICA’s multi-gate complexity (disease, platelet threshold, DIPSS risk, JAK inhibitor history, organ function) into a sequential triage engine — identifying avoidable barriers early.
- Intensified Late-Stage Recruitment: Brazil entered late in the global study yet rapidly became the #1 contributor after Brazil’s inclusion. Concentrated site engagement, fast feedback cycles and candidate-level tracking drove a 63.4% screen-to-randomization rate.
Results & Why This Matters
- Brazil contributed 52 randomized patients in 10 months — 12.8% of global randomization — with only 9.2% of subject-contributing sites.
- After Brazil’s first screened patient, the country generated 40.9% of all global randomizations — ranking #1 contributor from 2025-2026 and #2 globally.
- Brazil’s 3.47 randomized patients per site outperformed the global benchmark of 2.50 – a +39% productivity advantage driven by ODC’s targeted center selection and recruitment strategies.
PACIFICA Phase III Trial Details Pacritinib vs Physician’s Choice in Myelofibrosis with Severe Thrombocytopenia Harrison CN, et al. Blood. 2019;134(Suppl_1):4175 NCT03165734 – Swedish Orphan Biovitrum / CTI BioPharma
- 407 patients randomized
- 24 countries represented
- 15 Brazilian sites
- 52 Brazilian patients
