Latest Contract Research Organization News | SanaClis

When Progress Meets Its Hardest Tests

Written by Lora Bogoeva | Feb 4, 2026 11:09:40 AM

World Cancer Day is a reminder of both how far oncology has progressed, and where meaningful gaps remain. While many cancers now benefit from prevention, early detection, and increasingly effective therapies, others continue to demand sustained clinical innovation to improve long-term outcomes.

Hematologic malignancies fall firmly into this category. Despite decades of research and major therapeutic breakthroughs, blood cancers remain among the most complex and resource-intensive diseases to study and treat, with relapse and resistance still affecting a substantial proportion of patients.

Hematologic malignancies represent one of the most scientifically advanced yet operationally demanding areas in oncology clinical research. While therapeutic innovation has accelerated rapidly, blood cancers continue to challenge sponsors with biological diversity, complex treatment pathways, and demanding trial execution requirements.

Cancers of the blood, bone marrow, and lymphatic system, including leukemia, lymphoma, and multiple myeloma account for approximately 7% of all cancer cases worldwide and remain the fourth leading cause of cancer-related death globally. Despite declining mortality rates, relapse and drug resistance remain common, reinforcing the central role of clinical trials in advancing treatment options.

For sponsors, success in hematologic malignancy clinical trials depends on translating scientific progress into studies that are both innovative and operationally feasible.

February 4th, World Cancer Day

A High-Burden Disease Group: Among the Top 10 Cancers Worldwide

Hematologic malignancies rank among the top 10 human cancers globally in both incidence and mortality and account for approximately 7% of all cancer diagnoses worldwide. Global Burden of Disease data show that incident cases have increased steadily over the past three decades, reaching approximately 1.34 million new cases globally.

In Europe alone, around 300,000 patients are diagnosed with a blood cancer each year, including leukemia, lymphoma, and multiple myeloma. While age-standardized mortality rates have declined, incidence trends differ by region. In the United States, around 190,000 people are diagnosed each year with leukemia, lymphoma, or multiple myeloma, underscoring the substantial burden of hematologic malignancies across major clinical trial regions. Notably, leukemia incidence is declining globally but continues to increase in developed regions.

Disease burden is unevenly distributed, with hematologic malignancies consistently more common in men across subtypes and geographies. These epidemiological patterns directly influence trial feasibility, recruitment dynamics, and regional enrollment performance.

For sponsors designing multi-country clinical trials, understanding where global disease burden is concentrated ,and where incidence trends are shifting, is essential for realistic enrollment timelines and effective site selection.

Biologically Diverse Diseases with Fragmented Patient Populations

Hematologic malignancies encompass a broad spectrum of myeloid and lymphoid cancers, each characterized by distinct molecular drivers, disease trajectories, and treatment responses. Even within a single diagnosis, outcomes can vary substantially based on cytogenetic and biomarker profiles.

This biological diversity has enabled major advances in targeted therapy and precision medicine. At the same time, it has led to increasingly fragmented patient populations, smaller eligible cohorts, and more complex inclusion criteria.

Unlike cancers with strong prevention pathways, the exact cause of most hematologic malignancies remains unknown, limiting preventive strategies and placing sustained emphasis on clinical research across all stages of disease.

Treatment Progress, Yet 5-Year Survival Still Limited to 40–50%

Treatment strategies for hematologic malignancies have evolved significantly. Chemotherapy and hematopoietic stem cell transplantation remain foundational but are increasingly complemented by targeted therapies and immunotherapies.

Innovations such as BTK, BCL-2, FLT3, IDH, and JAK inhibitors, along with monoclonal antibodies and CAR-T cell therapies, have transformed outcomes in selected patient populations, particularly in relapsed or refractory disease.

Despite these advances, five-year survival rates across hematologic malignancies remain only 40–50%, with relapse and drug resistance continuing to limit long-term disease control. Treatment-related toxicity and financial burden further complicate care delivery, particularly in regions with restricted access to novel therapies.

Clinical Trial Innovation

Innovation with Operational Constraints: Clinical Trials in Hematologic Malignancies

Hematologic malignancy clinical trials are among the most complex in oncology. Many studies remain non-randomized and rely heavily on surrogate endpoints, reflecting both ethical considerations and rapidly evolving standards of care.

Advanced immunotherapies and cell-based treatments introduce additional operational challenges, including intensive safety monitoring, early toxicity detection, and specialized site capabilities. Safety remains a defining concern, as different therapeutic classes are associated with varying degrees of treatment-related adverse events.

Notably, older patients who represent a large proportion of the real-world hematologic malignancy population, remain underrepresented in many trials, limiting the applicability of results to routine clinical practice.

SanaClis and the Operational Reality

SanaClis supports sponsors operating in the complex reality of hematologic malignancy clinical research, where scientific ambition must be matched by operational precision. Blood cancer trials frequently involve demanding protocols, intensive safety oversight, and highly specialized clinical environments, requiring experienced teams and well-prepared sites.

SanaClis works with a focused network of hematology and oncology centres selected for their ability to deliver complex hematologic malignancy trials in real-world clinical settings. These centres demonstrate:

  • Experience with relapsed and refractory patient populations, including heavily pre-treated cohorts
  • Established pathways for early detection and management of treatment-related toxicities, particularly in advanced and immune-based therapies
  • Operational capacity to support high visit frequency and complex assessment schedules, without compromising data quality or patient safety
  • Familiarity with biomarker-driven enrollment and molecular stratification, enabling precise patient identification and protocol adherence

This site model enables more realistic feasibility assessments, reduced start-up delays, and more reliable enrollment performance in highly selected patient populations.

Clinical Operations and Supply Chain Under One Roof

In hematologic malignancies, especially in studies involving advanced or temperature-sensitive therapies, logistics failures become clinical risks. SanaClis integrates clinical operations with its clinical supply chain infrastructure to manage:

  • Investigational product flow and temperature control
  • Site readiness and pharmacy coordination
  • Timing-critical shipments
  • Alignment of dosing schedules with logistics windows
  • Procurement and supply of any back-ground treatments or ancillary products

This reduces protocol deviations, treatment delays, and avoidable site burden, issues that frequently disrupt complex oncology studies.

If your hematologic malignancy program involves complex populations, advanced therapies, or demanding operational requirements, SanaClis can support trial execution where clinical operations and supply chain must move together.