Chronic Myeloid Leukemia

Case Study:

Phase III Oncology Trial (Chronic Myeloid Leukemia)

Therapeutic Area:

Oncology – Chronic Myeloid Leukemia (CML)

Study Phase:

Phase III | International | Full-Service CRO Support

Background:

The investigational product is a novel, next-generation tyrosine kinase inhibitor (TKI) developed for the treatment of patients with chronic myeloid leukemia who are resistant or intolerant to standard therapies. The drug represents an innovative therapeutic option addressing an important unmet medical need in later-line CML treatment and has been successfully launched in EAEU.

Client Challenge:

The sponsor selected the EAEU region and India as the primary enrolling countries and required an experienced full-service CRO to manage a large, multinational Phase III clinical trial across emerging and complex regions. Key priorities included regulatory compliance, patient safety, robust data quality, and acceleration of patient enrollment in high-potential countries.

Smooth Drug Development Full-Service Solution:

Smooth Drug Development provided comprehensive, end-to-end CRO services, supporting the study from early planning through execution and close-out:

• Regulatory submissions and country-specific approval strategies

• Site feasibility, activation, and ongoing site management

• Clinical monitoring and logistics coordination

• Patient recruitment oversight and enrollment strategy optimization

• Data quality oversight and operational risk management

Study Scope & Geography:

• More than 53 clinical sites were opened across:

  – Pakistan

  – Turkey

  – EAEU

  – Kazakhstan

  – India

• EAEU and India were selected by the sponsor as the primary enrolling regions

• Active patient enrollment was driven predominantly in EAEU and India

Study Duration:

22 months

Key Challenges:

A total of 180 patients were enrolled in the study.

• Prolonged regulatory approval timelines in certain regions

• Recruitment complexity due to variability in access to standard treatments

• Need to rapidly scale enrollment in India within a competitive oncology landscape

• Requirement for strict ethical oversight across diverse healthcare systems

Targeted Enrollment Acceleration Strategy:

To boost enrollment in India, Smooth Drug Development implemented targeted recruitment initiatives:

• Engaged specialized Site Management Organizations (SMOs) with proven expertise in clinical oncology studies

• Strengthened site-level patient identification and pre-screening processes

• Established dedicated patient camps in India to identify, educate, and pre-screen potential study participants

• Enabled faster referral pathways and improved screening-to-enrollment conversion rates

Proactive & Risk-Based Approach:

Smooth Drug Development applied a structured, risk-based operational model:

• Close collaboration with local regulatory authorities to facilitate approvals

• Continuous site performance tracking with targeted support for high-enrolling sites

• Proactive issue identification and rapid corrective actions

• Transparent sponsor communication and regular risk reporting

Results & Outcomes:

• Successful execution of a large, multi-country Phase III Hematology trial

• Enrollment targets achieved through focused recruitment efforts in Russia and India

• Accelerated enrollment in India through SMO engagement and patient camp initiatives

• Full regulatory and GCP compliance maintained across all participating regions

• High-quality clinical data supporting regulatory and commercial objectives

• Contribution to the successful market launch of a novel CML therapy in EAEU

Why Smooth Drug Development:

Smooth Drug Development combines global operational expertise with strong regional execution capabilities to deliver complex late-phase oncology trials. Our full-service CRO model ensures control, quality, and confidence for sponsors navigating Phase III development in challenging and diverse markets.