Hematology trials demand data-driven feasibility, expert site selection, and hyper-efficient start-up

By Angela Hirst, Director, Site Alliance, Therapeutic Networks, Oncology

Csilla Szalay, Associate Director, Feasibility Strategy

Published on: May 29, 2026

This article is part of Parexel's Hematology playbook series that is comprised of five chapters on the strategic decisions that separate hematology programs that launch from those that stall — from first-in-human design to post-approval evidence.

Intro Chapter 1 Chapter 2 Chapter 3 Chapter 4 Chapter 5

Targeted therapies and immunotherapies have rewritten survival and mortality for blood cancers since the mid-1990s: 5-year relative survival has risen from 48% to 68% for leukemia, 32% to 62% for myeloma, and 56% to 74% for non-Hodgkin lymphoma.1 Non-malignant hematology has seen similar gains for hemophilia and sickle cell disease (SCD).  

Declining mortality rates have created a patient-recruitment bottleneck for hematology sponsors. Patients are living longer and are less likely to join clinical trials until multiple lines of therapy have failed. In malignant hematology, trials are rarely designed for broad categories such as acute myeloid leukemia (AML); they typically target highly specific subgroups, such as FLT3-mutated, relapsed/refractory AML with defined prior therapies. Some Phase III protocols now include more than 50 eligibility criteria, making it challenging to identify a single qualifying patient. In non-malignant conditions such as SCD, the proliferation of gene therapy trials has created recruitment fatigue within dedicated patient communities.  

Hematology sponsors must therefore be operationally excellent. At Parexel, we address these challenges through data-driven feasibility, a proprietary network of high-performing hematology sites, and streamlined site start-up. 

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